Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease
NCT ID: NCT03856853
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
144 participants
INTERVENTIONAL
2018-06-15
2021-05-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis
NCT03068234
Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
NCT03221257
Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis
NCT02821689
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
NCT02597933
Immunosuppressant Combined With Pirfenidone in CTD-ILD
NCT04928586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
treatment group
pirfenidone group
Pirfenidone
pirfenidone for SSc-ILD treatment
placebo group
placebo group
placebo
as control
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pirfenidone
pirfenidone for SSc-ILD treatment
placebo
as control
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
Exclusion Criteria
20. Major surgery is planned during the treatment period.
21. Pregnancy or lactation or make a schedule during the trials.
22. Give the drug 28 days before or after administration of the 3 month period, women of childbearing age \* are unwilling or unable to use contraceptive methods highly effective (according to ICH M3 (R2)), a highly effective means in the correct and consistent application of a barrier method when the failure rate of less than 1% per year. \* women of childbearing age is defined has undergone menarche and in line with "infertile women" standard "\[female infertile women" is defined as: postmenopausal period (12 months without menstruation, no other medical reasons) or permanent sterilization (e.g., tubal occlusion, hysterectomy, bilateral ovarian resection or bilateral tubal resection women)\].
(23)According to the researchers,exhibited evidence of alcohol or drug abuse. (24)Patients who were unable to understand or comply with the procedure were included in the self-administered questionnaire, which was completed without help.
25.Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment).
26.Clinical signs of malabsorption or needing parenteral nutrition. 27.With active peptic ulcer. 28.With mental illness . 29.Within 3 months to participate in other clinical trials. 30.Researchers determined that they did not participate in the trial.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Genomics, Inc.
INDUSTRY
GNI-EPS Pharmaceuticals, Inc. (GNI Group)
INDUSTRY
Beijing Continent Pharmaceutical Co, Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhang, Ling
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GNI-F647-1701
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.