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

CSL Behring23 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Immune Deficiency Disorder

Interventions

Immune globulin subcutaneous (Human)BIOLOGICAL

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).

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (9)

Study site

Nagoya, Aichi Pref., Japan

Study site

Chiba, Chiba Pref., Japan

Study site

Fukuoka, Fukuoka, Japan

Study site

Gifu, Gifu Pref., Japan

Outcomes

Primary Outcomes

Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion

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 \[i.e., possibly related, probably related, or related\]).

Time frame: 24 weeks

Secondary Outcomes

Overall Rate of AEs Per Infusion

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.

Time frame: 24 weeks

Number of Subjects With Newly Developing or Worsening AEs

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 \[i.e., possibly related, probably related, or related\]).

Time frame: 24 weeks

Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.