Trials / Completed
CompletedNCT00348296
Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Benesis Corporation · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | High-dose intravenous immunoglobulin (Venoglobulin-IH) |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2009-07-01
- Completion
- 2009-07-01
- First posted
- 2006-07-04
- Last updated
- 2010-07-30
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00348296. Inclusion in this directory is not an endorsement.