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

October 12, 2011
February 27, 2013
April 2011
February 2012   (final data collection date for primary outcome measure)
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]).
Median of the individual subject's rate of adverse events per infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
The rate will be calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered in this subject. The median rate will also be determined for AEs of mild, moderate and severe intensity and by causal relationship to study medication.
Complete list of historical versions of study NCT01458171 on ClinicalTrials.gov Archive Site
  • 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
  • Overall rate of adverse events per infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with newly developing or worsening adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of infusions with subject-assessed tolerability of at least 'good' [ Time Frame: 24 to 72 hours after infusion ] [ Designated as safety issue: No ]
  • IgG trough level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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.
  • Number of infection episodes [ 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 ]
  • Number of days of hospitalization due to infections [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Duration of use of antibiotics for infection prophylaxis and treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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.
Not Provided
 
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

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).

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Immune Deficiency Disorder
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
Experimental: IgPro20
Intervention: Biological: Immune globulin subcutaneous (Human)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
April 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01458171
ZLB07_001CR
Not Provided
CSL Behring
CSL Behring
Not Provided
Study Director: Midori Kobayashi CSL Behring K.K.
CSL Behring
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP