A MULTICENTER STUDY WITH 24 WEEKS OF TREATMENT PERIOD, TO ASSESS SAFETY, TOLERABILITY AND EFFICACY OF IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS WITH PIRFENIDONE 200MG ORAL TABLETS

Phase 4

Completed

• Conditions: Health Condition 1: null- Idiopathic pulmonary fibrosis (IPF)

• Registration Number: CTRI/2018/03/012430
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 211

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified