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Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis

Information source: Benesis Corporation
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Scleroderma, Systemic

Intervention: High-dose intravenous immunoglobulin (Venoglobulin-IH) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Benesis Corporation

Official(s) and/or principal investigator(s):
Kazuhiko Takehara, Professor, Study Chair, Affiliation: Kanazawa University

Overall contact:
Masashige Tsuda, Phone: +81-6-6201-1776, Email: 5709210@cc.m-pharma.co.jp

Summary

This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of GB-0998 for Treatment of Systemic Sclerosis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Changes in TSS at 12 weeks

Secondary outcome: Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who have sclerosis located proximal to the elbow joint with diffused systemic

scleroderma.

- Patients who have not less than 20 points of TSS.

- Patients with no appropriate therapeutic treatment.

Exclusion Criteria:

- Patients with severe hepatic disorder, severe renal disorder or severe heart

disorder.

- Patients with malignant tumors.

- Patients who have the anamnesis of shock or hypersensitivity to this drug.

- Patients who have the anamnesis of cerebral infarction or symptom of these diseases.

- Patients who have been diagnosed as IgA deficiency in their past history.

- Pregnant, lactating, and probably pregnant patients, and patients who want to become

pregnant.

- Patients who had any dose increase or new dosing of steroid within 12 weeks before

consent.

- Patients who were administered other investigational drug within 12 weeks before

consent.

Locations and Contacts

Masashige Tsuda, Phone: +81-6-6201-1776, Email: 5709210@cc.m-pharma.co.jp

Nagasaki University, Nagasaki 852-8501, Japan; Recruiting
Shinichi Sato, Professor, Principal Investigator
Additional Information

Starting date: July 2006
Ending date: September 2009
Last updated: March 22, 2007

Page last updated: November 03, 2008

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