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Phase 2/3 Study of IGSC, 20% in PIDD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01218438
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : February 15, 2017
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Brief Summary:
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency Diseases (PID) Biological: Immune Globulin Intravenous (Human), 10% Solution Drug: Immune Globulin Subcutaneous (Human), 20% Solution Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)
Actual Study Start Date : January 28, 2013
Actual Primary Completion Date : March 13, 2015
Actual Study Completion Date : March 13, 2015


Arm Intervention/treatment
Experimental: Study Epochs 1-4

Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.

Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.

Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.

Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.

Biological: Immune Globulin Intravenous (Human), 10% Solution
Intravenous infusion with IGIV, 10%
Other Names:
  • IGIV
  • 10%

Drug: Immune Globulin Subcutaneous (Human), 20% Solution
Subcutaneous infusion with IGSC, 20%
Other Names:
  • IGSC
  • 20%




Primary Outcome Measures :
  1. Rate of Acute Serious Bacterial Infections Per Year (ASBI) [ Time Frame: 1 year ]
    Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.


Secondary Outcome Measures :
  1. Annual Rate of All Infections Per Participant [ Time Frame: 1 year ]
  2. Annual Rate of Sinus Infections Per Participant [ Time Frame: 1 year ]
  3. Annual Rate of Fever Episodes Per Participant [ Time Frame: 1 year ]
  4. Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant [ Time Frame: 1 year ]
  5. Annual Rate of Days on Antibiotics Per Participant [ Time Frame: 1 year ]
  6. Annual Rate of Hospitalizations for Illness or Infection Per Participant [ Time Frame: 1 year ]
  7. Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant [ Time Frame: 1 year ]
  8. Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant [ Time Frame: 1 year ]
  9. Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old) [ Time Frame: Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18 ]
    IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution; AUCSC = area under the concentration-time curve following subcutaneous administration; AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval

  10. Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals [ Time Frame: Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2) ]
  11. Trough Levels of Anti-Tetanus Antibody [ Time Frame: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2) ]
  12. Trough Levels of Anti-Haemophilus Influenza B Antibody [ Time Frame: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2) ]
  13. Trough Levels of Anti-Hepatitis B Antibody [ Time Frame: Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2) ]
  14. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)

  15. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.

  16. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)

  17. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

  18. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The minimum time (Tmax) to reach the maximum concentration (Cmax)

  19. Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

  20. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )

  21. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.

  22. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)

  23. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

  24. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The minimum time (Tmax) to reach the maximum concentration (Cmax)

  25. Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin) [ Time Frame: Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18 ]
    The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).

  26. Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table) [ Time Frame: 29 weeks ]
    There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals. To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured. The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4. This was an interim study analysis.

  27. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant [ Time Frame: Up to 20 months per subject (throughout entire study) ]
    Number of related SAEs and AEs divided by number of participants

  28. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion [ Time Frame: Up to 20 months per subject (throughout entire study) ]
    Number of related SAEs and AEs divided by number of subjects and divided by number of infusions

  29. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant [ Time Frame: Up to 20 months per subject (throughout entire study) ]
    Number of all SAEs and AEs divided by number of participants

  30. Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion [ Time Frame: Up to 20 months per subject (throughout entire study) ]
    Number of all SAEs and AEs divided by number of infusions

  31. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant [ Time Frame: Within 72 hours of completion of infusion ]
    Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants

  32. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion [ Time Frame: Within 72 hours of completion of infusion ]
    Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions

  33. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant [ Time Frame: Within 24 hours of completion of infusion ]
    Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants

  34. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion [ Time Frame: Within 24 hours of completion of infusion ]
    Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions

  35. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant [ Time Frame: Within 1 hour of completion of infusion ]
    Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants

  36. Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion [ Time Frame: Within 1 hour of completion of infusion ]
    Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions

  37. Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion [ Time Frame: Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs ]
    The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion ("temporally associated") plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug("related"), divided by the total number of infusions

  38. Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs) [ Time Frame: Up to 20 months (throughout entire study) ]
    The number of infusions associated with local non-SAEs divided by the total number of infusions.

  39. Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs) [ Time Frame: Up to 20 months (throughout entire study) ]
  40. Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs [ Time Frame: Up to 20 months (throughout entire study) ]
  41. Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs [ Time Frame: Up to 20 months (throughout entire study) ]
  42. Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration [ Time Frame: Up to 20 months (throughout entire study) ]
    An infusion will be deemed as tolerated unless one of the following occurs: 1. Any serious related AE(s) 2. Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion 3. Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion

  43. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  44. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  45. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  46. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  47. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  48. Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  49. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  50. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  51. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  52. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  53. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  54. Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  55. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  56. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  57. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  58. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  59. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  60. Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  61. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  62. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  63. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  64. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  65. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  66. Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  67. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  68. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  69. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  70. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  71. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  72. Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3 [ Time Frame: Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion ]
    Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.

  73. Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration [ Time Frame: Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40 ]
    Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.

  74. Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years [ Time Frame: Up to 20 months (throughout entire study) ]
    The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.

  75. Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age [ Time Frame: Up to 20 months (throughout entire study) ]
    The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.

  76. Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older [ Time Frame: Up to 20 months (throughout entire study) ]
    The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.

  77. Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old [ Time Frame: Up to 20 months per subject (throughout entire study) ]
    TSQM; for the age group 2 to 12 years the observer will be a parent. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

  78. Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older [ Time Frame: Up to 20 months per subject (throughout entire study) ]
    TSQM; for the age group 13 years and older the observer will be the participant. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

  79. Life Quality Index - 2 to 12 Years Old [ Time Frame: Up to 20 months (throughout entire study) ]
    For the age group 2 to 12 years the respondent will be a parent. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.

  80. Life Quality Index - 13 Years and Older [ Time Frame: Up to 20 months per subject (throughout entire study) ]
    For the age group 13 years and older the respondent will be the participant. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
  • Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
  • Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
  • Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
  • Serum trough level of IgG > 500 mg/dL at screening
  • Participant is willing and able to comply with the requirements of the protocol

Main Exclusion Criteria:

  • Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2
  • Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):

    • Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) > 2.5 times the upper limit of normal for the testing laboratory
    • Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] ≤500/mm^3)
  • Creatinine clearance (CLcr) value that is < 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula
  • Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
  • Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia
  • Abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
  • Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site
  • Acute serious bacterial infection within 3 months prior to screening
  • Ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following intravenous immunoglobulin, subcutaneous immunoglobulin, and/or Immune Serum Globulin (ISG) infusions
  • Severe immunoglobulin A (IgA) deficiency (less than 0.07g/L) with known anti-IgA antibodies and a history of hypersensitivity
  • Participant is on continuous systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and, in the opinion of the investigator, cannot stop these for the duration of the study without putting the patient at risk of increased infections
  • Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening
  • Bleeding disorder or thrombocytopenia with a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy
  • Total protein > 9 g/dL or myeloma or macroglobulinemia (IgM) or paraproteinemia
  • Severe dermatitis that would preclude adequate sites for safe product administration
  • Women of childbearing potential meeting any one of the following criteria:

    • Participant presents with a positive pregnancy test
    • Participant is breast feeding
    • Participant intends to begin nursing during the course of the study
    • Participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom [for male partner] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study
  • Participation in another clinical study and exposure to an investigational product or device within 30 days prior to study enrollment (exception: treatment in a previous Baxter immunoglobulin study)
  • Participant is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an investigational product or device during the course of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218438


Locations
Show Show 18 study locations
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
Layout table for investigator information
Study Director: Study Director Takeda
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01218438    
Other Study ID Numbers: 170904
First Posted: October 11, 2010    Key Record Dates
Results First Posted: February 15, 2017
Last Update Posted: July 20, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/
Additional relevant MeSH terms:
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Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genetic Diseases, Inborn
Pharmaceutical Solutions
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs