Status:
UNKNOWN
Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)
Lead Sponsor:
Beijing Kawin Technology Share-Holding Co., Ltd.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of lung disease characterized by fibrosis of the supporting framework (interstitium) of the lungs. By definition, the term is used on...
Eligibility Criteria
Inclusion
- Written informed consent signed;
- 18-75 years of age;
- Clinically or multidisciplinarily diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
- Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.
Exclusion
- Allergic to pirfenidone;
- Dyspnea symptoms relieved in the past 6 months;
- Patients in acute exacerbation phase;
- Diabetic patients whose fasting venous glucose \>11.1 mmol/L;
- Patients with malignant tumor and hemorrhagic diseases;
- Patients with serious underlying pulmonary disease;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times above the upper level of normal value range), kidney disease(Cr above the upper level of normal value range);
- Patients who has taken Acetylcysteine in the past 3 months;
- Patients who has taken Prednisone\>15mg/day(or other equivalent amount of glucocorticoid) and/or Immunosuppresants in the past 3 months;
- Patients who has taken interferon, penicillamine, colchine or other agents for the treatment of IPF;
- Pregnant or lactating women;
- Participated in other clinical trials in the past 1 month;
- The investigator assessed as inappropriate to participate in this clinical trial.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01504334
Start Date
January 1 2012
End Date
March 1 2013
Last Update
February 7 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijng, China, 100032