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

NCT01458171 | Completed Phase 3 Results

• 1 other identifier: ZLB07_001CR
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

Brief Summary

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).

Conditions

Primary Immune Deficiency Disorder

Keywords

Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (9)

• Overall Rate of AEs Per Infusion

  24 weeks

• Number of Subjects With Newly Developing or Worsening AEs

  24 weeks

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

  24 to 72 hours after infusion

• IgG Trough Level

  24 weeks

• Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)

  24 weeks

Other Outcomes (1)

• Rate of Infection Episodes (Serious and Non-serious)

  24 weeks

Study Arms (1)

IgPro20

EXPERIMENTAL

Biological: Immune globulin subcutaneous (Human)

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).

Also known as: Hizentra

IgPro20

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (9)

Study site

Nagoya, Aichi Pref., 466-8560, Japan

Location

Study site

Chiba, Chiba Pref., 260-8677, Japan

Location

Study site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Study site

Gifu, Gifu Pref., 502-8558, Japan

Location

Study site

Sapporo, Hokkaido, 060-8648, Japan

Location

Study site

Moriguchi, Osaka, 570-8507, Japan

Location

Study site

Koshigaya, Saitama Pref., 343-8555, Japan

Location

Study site

Tokorozawa, Saitama Pref., 359-8513, Japan

Location

Study site

Bunkyō City, Tokyo Metropolitan, 113-8519, Japan

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

gamma-Globulins; Hizentra

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: CSL Behring

clinicaltrials@cslbehring.com

Use email contact

Study Officials

• Midori Kobayashi

  CSL Behring K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 24, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 9, 2013
• Results First Posted: April 9, 2013

Record last verified: 2013-02

Locations

JP (9)