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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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 (exclusion criteria 16 and 17 and the combined use of early precautions). 19. Previous or planned hematopoietic stem cell transplantation next year. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03856853
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Beijing Continent Pharmaceutical Co, Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustryIndustry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zhang, Ling, Beijing, Beijing, China

Status

Recruiting

Address

Zhang, Ling

Beijing, Beijing, 100102

Site Contact

Ling Zhang

rlzhang1006@163.com

+86-13501209210

Terms of Service

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