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Study of Octanorm Subcutaneous IG in Patients With PID

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ClinicalTrials.gov Identifier: NCT01888484
Recruitment Status : Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief Summary:
This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacokinetic (PK) characteristics of octanorm.

Condition or disease Intervention/treatment Phase
Primary Immune Deficiency Disorder Biological: octanorm 16.5% Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases
Study Start Date : March 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Octanorm 16.5%
octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.
Biological: octanorm 16.5%
octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.




Primary Outcome Measures :
  1. To assess the efficacy of octanorm in preventing serious bacterial infections (SBI) [ Time Frame: Every 4 weeks until the final evaluation at week 65. ]
    The primary efficacy outcome is the rate of SBI (defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess) per person-year on treatment.

  2. To evaluate the pharmacokinetic (PK) characteristics of octanorm [ Time Frame: Measured at Week 12 and Week 28 ]
    The primary endpoint with respect to the PK investigations is the AUC from time 0 (start of the infusion) to the end of the nominal dosing period, standardized to 1 week (AUCτ), at steady-state conditions.



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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of at least 2 years up to and including 75 years.
  2. Confirmed diagnosis of PI as defined by the ESID and PAGID and requiring immunoglobulin replacement therapy due to hypogammaglobulinaemia or agammaglobulinaemia. The exact type of PI should be recorded.
  3. Patients with at least 6 infusions on regular treatment with any IVIG, there of a minimum of the last 2 months on the same product prior to entering the study. Constant IVIG dose between 200 and 800 mg/kg body weight (±20% of the mean dose for the last 6 infusions).
  4. Availability of the IgG trough levels of 2 previous IVIG infusions before enrollment, and maintenance of greater than or equal to 5.0 g/L in the trough levels of these 2 previous infusions.
  5. Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study.
  6. For adult patients: freely given written informed consent. For minor patients: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with the applicable regulatory requirements.
  7. Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.

Exclusion Criteria:

  1. Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
  2. Known history of adverse reactions to IgA in other products.
  3. Patients with body mass index ≥40 kg/m2.
  4. Exposure to blood or any blood product or plasma derivatives, other than IVIG treatment for PID, within the past 3 months prior to the first infusion of octanorm.
  5. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product (such as Polysorbate 80).
  6. Requirement of any routine premedication for IgG administration.
  7. History of malignancies of lymphoid cells and immunodeficiency with lymphoma.
  8. Severe liver function impairment (ALAT 3 times above upper limit of normal).
  9. Known protein-losing enteropathies or proteinuria.
  10. Presence of renal function impairment (creatinine greater than 120 uM/L), or creatinine greater than 1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
  11. Treatment with oral or parenteral steroids for greater than or equal to 30 days or when given intermittently or as bolus at daily doses greater than or equal to 0.15 mg/kg.
  12. Treatment with immunosuppressive or immunomodulatory drugs.
  13. Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of octanorm.
  14. Treatment with any investigational medicinal product within 3 months prior to first infusion of octanorm.
  15. Presence of any condition, that is likely to interfere with the evaluation of study medication or satisfactory conduct of the trial.
  16. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of octanorm.
  17. Known or suspected HIV, HCV, or HBV infection.
  18. Pregnant or nursing women.
  19. Planned pregnancy 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): NCT01888484


Locations
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United States, Alabama
Octapharma Research Site
Birmingham, Alabama, United States, 35233
United States, California
Octapharma Research Site
Irvine, California, United States, 92697
Octapharma Research Site
San Diego, California, United States, 92123
United States, Colorado
Octapharma Research Site
Centennial, Colorado, United States, 80112
United States, Nebraska
Octapharma Research Site
Omaha, Nebraska, United States, 68046
United States, Ohio
Octapharma Research Site
Toledo, Ohio, United States, 43617
United States, Texas
Octapharma Research Site
Frisco, Texas, United States, 75034
Canada
Octapharma Research Site
Edmonton, Canada, T6G 2V2
Octapharma Research Site
Montreal, Canada, H3H 1P3
Czechia
Octapharma Research Site
Brno, Czechia, 656 91
Octapharma Research Site
Olomouc, Czechia, 775 20
Octapharma Research Site
Pilsen, Czechia, 304 60
Octapharma Research Site
Prague, Czechia, 150 06
Hungary
Octapharma Research Site
Budapest, Hungary, 1097
Poland
Octapharma Research Site
Bialystok, Poland, 15-274
Octapharma Research Site
Krakow, Poland, 30-663
Octapharma Research Site
Krakow, Poland, 31-024
Octapharma Research Site
Lublin, Poland, 20-093
Russian Federation
Octapharma Research Site
Moscow, Russian Federation, 117198
Octapharma Research Site
Saint Petersburg, Russian Federation, 197101
Octapharma Research Site
Yekaterinburg, Russian Federation, 620149
Slovakia
Octapharma Research Site
Bratislava, Slovakia
Octapharma Research Site
Košice, Slovakia
Octapharma Research Site
Martin, Slovakia
Sponsors and Collaborators
Octapharma
Investigators
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Study Director: Wolfgang Frenzel International Medical Monitor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01888484     History of Changes
Other Study ID Numbers: SCGAM-01
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Octapharma:
PID
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs