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Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Immune Deficiency

Intervention: Immune globulin subcutaneous (Human) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Yusuke Watanabe, Study Director, Affiliation: CSL Behring K.K.

Summary

The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).

Clinical Details

Official title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Annualized rate of infection episodes

Secondary outcome:

Number of subjects with adverse events (AEs)

Percentage of subjects with adverse events (AEs)

Rate of AEs per infusion

Annualized rate of clinically documented serious bacterial infections (SBIs)

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

Duration of use of antibiotics for infection prophylaxis and treatment

Median serum IgG concentration

Eligibility

Minimum age: N/A. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who have completed the preceding follow-up study ZLB07_001CR.

- Written informed consent by the subject/parent/legally acceptable representative.

Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject. Exclusion Criteria:

- Pregnancy or nursing mother.

- Participation in a study with an investigational medicinal product (IMP) within 3

months prior to enrollment except for study ZLB07_001CR.

- Subjects who are planning to donate blood during the study.

- Known or suspected antibodies to the IMP, or to excipients of the IMP.

- Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.

Locations and Contacts

Study site, Nagoya city, Aichi Pref. 466-8560, Japan

Study site, Chiba city, Chiba Pref. 260-8677, Japan

Study site, Fukuoka city, Fukuoka 812-8582, Japan

Study site, Gifu city, Gifu Pref. 502-8558, Japan

Study Site, Sapporo city, Hokkaido 060-8648, Japan

Study site, Moriguchi city, Osaka 570-8507, Japan

Study site, Koshigaya city, Saitama Pref. 343-8555, Japan

Study site, Tokorozawa city, Saitama Pref. 359-8513, Japan

Study site, Bunkyo-ku, Tokyo Metropolitan 113-8519, Japan

Additional Information

Starting date: October 2011
Last updated: November 25, 2014

Page last updated: August 23, 2015

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