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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scleroderma, Systemic

Keywords

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Scleroderma, Systemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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High-dose intravenous immunoglobulin (Venoglobulin-IH)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kazuhiko Takehara, Professor

Role: STUDY_CHAIR

Kanazawa University

Locations

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Nagasaki University

Nagasaki, Nagasaki, Japan

Site Status

Countries

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Japan

References

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Takehara K, Ihn H, Sato S. A randomized, double-blind, placebo-controlled trial: intravenous immunoglobulin treatment in patients with diffuse cutaneous systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):151-6. Epub 2013 Jul 23.

Reference Type DERIVED

PMID: 23910617 (View on PubMed)

Other Identifiers

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0998-A1

Identifier Type: -

Identifier Source: org_study_id