Health Condition 1: null- Idiopathic pulmonary fibrosis (IPF)
Conditions
Interventions
Intervention1: Pirfenidone: Pirfenidone 200mg oral tablets for 24 week.
Control Intervention1: NA: NA
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. A written signed and dated informed consent form from subjects and/or legally acceptable representatives 2. Subjects of either gender of 18 years of age and above 3. Subjects with diagnosis of Idiopathic Pulmonary Fibrosis 4. Subjects who are treatment naïve or who are already on treatment with Pirfenidone 200mg oral tablets suitable to complete titration phase of 6 weeks and continue the study with dosage 1800mg/day or above as per Investigatorâ??s discretion from baseline visit or who are already on treatment with Pirfenidone 200mg oral tablets with dosage 1800mg/day or above as per Investigatorâ??s discretion
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to Pirfenidone or any of its components 2. Subjects with history of angioedema with pirfenidone 3. Subjects with concomitant use of fluvoxamine 4. Subjects with severe hepatic impairment or end stage liver disease (Child Pugh Class C) 5. Subjects with severe renal impairment (CrCl stage renal disease requiring dialysis 6. Subjects with cardiac disease not secondary to lung disease, chronic liver disease, chronic renal disease, malignancy and Immunosuppression 7. Subjects with pregnancy or breast feeding 8. Abnormal laboratory investigations as judged by Investigator (SCR-2) 9. Participated in any clinical trial within 3 months from SCR-1. 10. Subject unsuitable to participate in the study as per the discretion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| · Adverse events and relevant abnormal laboratory findings (serious/ non-serious, expected/ unexpected, related/ nonrelated) · Percentage of subjects with adverse events · Percentage of subjects requiring dose reductions · Treatment discontinuation ratesTimepoint: week 4, 8 and 24 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| · Mean change in 6-MWT at week 4, 8 and 24 from baseline · Mean change in FEV1 and FVC at week 4, 8 and 24 from baselineTimepoint: week 4, 8 and 24 from baseline | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Ltd.
Outcome results
None listed