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Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

NCT03068234 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-03-01

No results posted yet for this study

Summary

This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis.

Conditions

Interventions

DRUG

Pirfenidone

A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.

DRUG

Placebo oral capsule

Placebo for pirfenidone capsule

DRUG

Steroids

Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2019-04-30
Completion
2019-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068234 on ClinicalTrials.gov