Phase II Study of Recombinant Relaxin for Progressive 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

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-12-31

Study Completion Date

1997-12-31

Brief Summary

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OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma).

II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.

Detailed Description

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PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.

Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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relaxin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Progressive systemic sclerosis (scleroderma)
* No pregnant or nursing women

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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G. Scott Herron

Role: STUDY_CHAIR

Stanford University

Other Identifiers

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SUMC-37488

Identifier Type: -

Identifier Source: secondary_id

199/12015