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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348296
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : July 30, 2010
Information provided by:
Benesis Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Scleroderma, Systemic Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
Study Start Date : July 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Primary Outcome Measures :
  1. Changes in TSS at 12 weeks

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00348296

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Nagasaki University
Nagasaki, Japan, 852-8501
Sponsors and Collaborators
Benesis Corporation
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Study Chair: Kazuhiko Takehara, Professor Kanazawa University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00348296    
Other Study ID Numbers: 0998-A1
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: July 2010
Keywords provided by Benesis Corporation:
Scleroderma, Systemic
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs