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

NCT00348296 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-07-30

No results posted yet for this study

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.

Conditions

  • Scleroderma, Systemic

Interventions

DRUG

High-dose intravenous immunoglobulin (Venoglobulin-IH)

Sponsors & Collaborators

  • Benesis Corporation

    lead INDUSTRY

Principal Investigators

  • Kazuhiko Takehara, Professor · Kanazawa University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00348296 on ClinicalTrials.gov