CTRI/2018/03/012430CompletedPhase 4
A PHASE IV, PROSPECTIVE, OPEN LABEL, NON-COMPARATIVE, MULTICENTER STUDY WITH24 WEEKS OF TREATMENT PERIOD TO ASSESS SAFETY, TOLERABILITY AND EFFICACY OFPIRFENIDONE 200MG ORAL TABLETS IN PATIENTS WITH IDIOPATHIC PULMONARYFIBROSIS (IPF)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cipla Ltd
- Enrollment
- 211
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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 <30 ml/min) or end
- •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
- •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
Investigators
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