Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01458171
First received: October 12, 2011
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).


Condition Intervention Phase
Primary Immune Deficiency Disorder
Biological: Immune globulin subcutaneous (Human)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).


Secondary Outcome Measures:
  • Overall Rate of AEs Per Infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.

  • Number of Subjects With Newly Developing or Worsening AEs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).

  • Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good' [ Time Frame: 24 to 72 hours after infusion ] [ Designated as safety issue: No ]
    Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as "very good", "good", "fair", or "poor". The reported percentage represents the percentage of subjects with local tolerability assessments of "very good" or "good" at any given study infusion.

  • IgG Trough Level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown

  • Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.

  • Number of Infection Episodes (Serious and Non-serious) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.

  • Number of Days of Hospitalization Due to Infections. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Median number of days of hospitalization due to infections.

  • Duration of Use of Antibiotics for Infection Prophylaxis and Treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Median number of days of use of antibiotics for infection prophylaxis and/or treatment


Other Outcome Measures:
  • Rate of Infection Episodes (Serious and Non-serious) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the FAS population and the PPS population and adjusted to 365 days.


Enrollment: 23
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IgPro20 Biological: Immune globulin subcutaneous (Human)
IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
Other Name: Hizentra

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
  • Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.

Exclusion Criteria:

  • Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
  • Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration >0.2 g/L or urine protein ++ by dipstick).
  • Pregnancy or nursing mother.
  • Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
  • Subjects who are planning to donate blood during the study.
  • Re-entry of subjects previously participating in the current follow-up study.
  • Known or suspected antibodies to the IMP, or to excipients of the IMP.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458171

Locations
Japan
Study site
Nagoya city, Aichi Pref., Japan, 466-8560
Study site
Chiba city, Chiba Pref., Japan, 260-8677
Study site
Fukuoka city, Fukuoka, Japan, 812-8582
Study site
Gifu city, Gifu Pref., Japan, 502-8558
Study site
Sapporo city, Hokkaido, Japan, 060-8648
Study site
Moriguchi city, Osaka, Japan, 570-8507
Study site
Koshigaya city, Saitama Pref., Japan, 343-8555
Study site
Tokorozawa city, Saitama Pref., Japan, 359-8513
Study site
Bunkyo-ku, Tokyo Metropolitan, Japan, 113-8519
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Midori Kobayashi CSL Behring K.K.
  More Information

No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01458171     History of Changes
Other Study ID Numbers: ZLB07_001CR
Study First Received: October 12, 2011
Results First Received: February 27, 2013
Last Updated: February 27, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by CSL Behring:
Immune globulin subcutaneous
SCIG
Primary immunodeficiency
PID

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014