Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)
Conditions
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)
Interventions
DRUGPirfenidone
pirfenidone for SSc-ILD treatment
OTHERplacebo
as control
Sponsors
Shanghai Genomics, Inc.
GNI-EPS Pharmaceuticals, Inc. (GNI Group)
Beijing Continent Pharmaceutical Co, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.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.
Exclusion criteria
1. Subjects not fulfill all of the above inclusion criteria. 2. AST, ALT \>1.5 x ULN. 3. Bilirubin \>1.5 x ULN. 4. Creatinine clearance \<30 mL/min. 5. Airway obstruction (pre-bronchodilator FEV1/FVC \<0.7). 6. Other clinically significant pulmonary abnormalities. 7. Allergic to test drugs or components (e.g. lactose). 8. Clinical Significant Pulmonary hypertension:. 1. Significant past clinical evidence or echocardiography of right heart failure. 2. History of right heart catheterization showed that cardiac index ≤ 2 l/min/m2. 3. Pulmonary hypertension, which needs to use EPoprostenol/ Treprostinil for parenteral treatment . 9. Cardiovascular diseases: 1. Six weeks in severe hypertension, and out of control after treatment(≥160/100mmHg). 2. Myocardial infarction within six months. 3. A period of 6 months in unstable angina. 10. More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers. 11. Bleeding risk, including the following criterias: a. Predisposition to bleeding. b.Subjects need to the following treatments: i.Fibrinolysis, full-dose anticoagulation therapy(such as vitamin K antagonists, direct thrombin inhibitor, heparin, Hirudin ). ii. High dose antiplatelet therapy\[Note: not prohibited to maintain equipment needed indwelling venous pathway prophylactic low dose of heparin or heparin fluid (e.g. enoxaparin, daily 4000 I.U. s.c.) and the prevention of the use of antiplatelet therapy (e.g. acetylsalicylic acid, until 325 mg/d, or other antiplatelet dose of 75 mg/d the same dose of clopidogrel, or treatment)\]. c.history of hemorrhagic central nervous system (CNS) event within last year. d. Any of the following conditions within 3 months: i.Hemoptysis or hematuria ii. Active gastrointestinal bleeding or gastrointestinal ulcer. iii. major trauma or major surgery (researchers determined). e.coagulation parameters:international normalised ratio (INR) \>2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \>1.5 x ULN) 12. May interfere with detection procedures (such as interrupt oxygen intolerance in pulmonary function tests) or based on the researchers estimate, may affect the test to participate in or participate in the test may put patients at risk of disease or other complications (such as caused by SSc severe gastrointestinal symptoms). 13. Researchers determined that life expectancy was due to other diseases (non SSc) for a period of up to 2.5 years. 14. Clinical signs of malabsorption or needing parenteral nutrition. 15. History of thrombotic event within last year(Including stroke and transient ischemic attack). 16. Previous treatment with nintedanib or pirfenidone. 17. Use the following medicine: 1. Treatment with prednisone \>10 mg/day within 2 weeks. 2. Treatment with azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine within 8 weeks . 3. Treatment with cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium para-aminobenzoate within 6 months. 18. Unstable background therapy with cyclophosphamide or mycophenolate mofetil / sodium or methotrexate (not allow treatment). Patients must or A. patients cannot receive immunosuppressive therapy, sodium cyclophosphamide or mycophenolate mofetil / or MTX stable or B. within 6 months of acceptance, and in at least 6 months after randomization, the treatment to keep the background stable (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change from baseline (%) of FVC% | 52 Weeks |
Countries
China
Outcome results
None listed