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Completed

NCT Number: NCT00348296

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

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.

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Key information

Conditions

Scleroderma, Systemic Connective Tissue Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagasaki University

Nagasaki, 852-8501, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-dose intravenous immunoglobulin (Venoglobulin-IH)

Drug

Primary outcomes

  1. Changes in TSS at 12 weeks

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benesis Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2006
Registry last updated
Jul 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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