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Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease

NCT03856853 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2019-02-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the eEfficacy and safety of pirfenidone in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Conditions

  • Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)

Interventions

DRUG

Pirfenidone

pirfenidone for SSc-ILD treatment

OTHER

placebo

as control

Sponsors & Collaborators

  • Shanghai Genomics, Inc.

    collaborator INDUSTRY

  • GNI-EPS Pharmaceuticals, Inc. (GNI Group)

    collaborator INDUSTRY

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2021-02-10
Completion
2021-05-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03856853 on ClinicalTrials.gov