MA39189 Trial Of Pirfenidone in Patients with Fibrosing uILD
MULTICENTER, INTERNATIONAL, DOUBLE-BLIND, TWO-ARM, RANDOMIZED, PLACEBO-CONTROLLED PHASE II TRIAL OF PIRFENIDONE IN PATIENTS WITH UNCLASSIFIABLE PROGRESSIVE FIBROSING ILD
F Hoffmann-La Roche Ltd
Duration of Study in the UK
1 years, 9 months, 0 days
Currently there is no specific treatment for patients with unclassifiable ILD and each patient must be treated on a case by case basis.
Pirfenidone is an experimental drug that may help to reduce scarring and swelling in the lungs.
This phase II study is designed to assess the affects, good or bad pirfenidone has on patients and their ILD, compared to a placebo (an inactive substance that looks like pirfenidone).
The study will enroll approximately 250 patients globally who will be randomly allocated to one of two treatment arms:
- Arm A: Pirfenidone (capsules)
- Arm B: Placebo (capsules)
Neither the patient or doctor will know which treatment has been allocated, this is known as a double blind study. Treatment allocation will only be revealed if there is a safety concern or at the end of the study.
The study will consist of the following stages:
• Washout Period
• Screening Period
• Double blind treatment
• Safety Follow-Up (includes optional Pirfenidone treatment)
Eligible patients will be assessed for safety & efficacy which will include regular blood tests, lung function tests, heart function as well as regular reviews by a study doctor. During the double blind treatment period patients will receive the study drug (pirfenidone or placebo) and will take the capsules 3 times each day over 24 weeks.
After completion of the double-blind treatment period, patients will be offered the possibility to receive Pirfenidone within the safety follow-up period for up to 12 months and will be required to attend clinic during this time.
The total length of the study is expected to be 1 year and 9 months.
The study is expected to be conducted in 12 research sites in the UK.
This study is sponsored by Roche Products Ltd in the UK.
North East - Newcastle & North Tyneside 1 Research Ethics Committee
Date of REC Opinion
24 May 2017
Further Information Favourable Opinion