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

NCT03856853 | Unknown Phase 3

• 1 other identifier: GNI-F647-1701
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline (%) of FVC%

  52 Weeks

Study Arms (2)

treatment group

EXPERIMENTAL

pirfenidone group

Drug: Pirfenidone

placebo group

PLACEBO COMPARATOR

placebo group

Other: placebo

Interventions

Pirfenidone DRUG

pirfenidone for SSc-ILD treatment

treatment group

placebo OTHER

as control

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects aged between 18 and 75 years of age. 2.2013 ACR / EULAR classification criteria for SSc fulfilled. 3.SSc disease onset (defined by first non-Raynaud symptom) within 5 years. 4.SSc related Interstitial Lung Disease confirmed by HRCT. 5.Forced vital capacity (FVC) 40% to 70% predicted(include 40% and70% ). 6.Subject have the ability to understand and sign the informed consent before the trials.

You may not qualify if:

• AST, ALT \>1.5 x ULN.
• Bilirubin \>1.5 x ULN.
• Creatinine clearance \<30 mL/min.
• Airway obstruction (pre-bronchodilator FEV1/FVC \<0.7).
• Other clinically significant pulmonary abnormalities.
• Allergic to test drugs or components (e.g. lactose).
• Clinical Significant Pulmonary hypertension:.
• Significant past clinical evidence or echocardiography of right heart failure.
• History of right heart catheterization showed that cardiac index ≤ 2 l/min/m2.
• Pulmonary hypertension, which needs to use EPoprostenol/ Treprostinil for parenteral treatment .
• Cardiovascular diseases:
• Six weeks in severe hypertension, and out of control after treatment(≥160/100mmHg).
• Myocardial infarction within six months.
• A period of 6 months in unstable angina.
• More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers.

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead
• Shanghai Genomics, Inc.: collaborator
• GNI-EPS Pharmaceuticals, Inc. (GNI Group): collaborator

Study Sites (1)

Zhang, Ling

Beijing, Beijing Municipality, 100102, China

RECRUITING

MeSH Terms

Interventions

pirfenidone

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 27, 2019
• Study Start: June 15, 2018
• Primary Completion: February 10, 2021
• Study Completion: May 10, 2021
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

CN (1)