Status:
COMPLETED
Pilot Study of Pirfenidone in Pulmonary Fibrosis With Anti-myeloperoxydase Antibodies
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Roche Pharma AG
URC-CIC Paris Descartes Necker Cochin
Conditions:
Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine wether pirfenidone is safe and effective in the treatment of pulmonary fibrosis with anti-myeloperoxydase (MPO) antibodies or pulmonary fibrosis with anti-MPO...
Detailed Description
Pulmonary fibrosis can be associated with Anti-Neutrophil Cytoplasmic Antibody (ANCA) directed against MPO or with anti-MPO associated vasculitis, leading to increased disability and poor prognosis. T...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Presence of anti-MPO antibody (ELISA) at inclusion or during pulmonary fibrosis follow-up and/or diagnosis of anti-MPO associated vasculitis according to the 2012 Revised International Chapel Hill Consensus Conference definitions
- Definite or possible Usual Interstitial Pneumonia or Non Specific Interstitial Pneumonia based on high-resolution computed tomography
- Presence of pulmonary fibrosis, defined as a range of 50 to 90% of the %FVC and a range of 30 to 90% of the %DLCO
- Pulmonary fibrosis refractory (according to the investigator's judgment) to a conventional regimen used for anti-MPO associated vasculitis when a treatment against vasculitis has been used
- Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information) and comply with the study protocol procedures (including required study visits)
- Have affiliation with a mode of social security (profit our being entitled).
Exclusion
- Other type of systemic vasculitis;
- Active vasculitis defined by Birmingham Vasculitis Activity Score \>3 (BVAS) ;
- Contraindication to Pirfenidone;
- Unable to perform pulmonary function test (PFT);
- Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study : implants of levonorgestrel; injectable progesterone; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progesterone only); double barrier method (condom, cervical cap or diaphragm with spermicidal agent); transdermal contraceptive patch; male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject;
- Any of the following liver function test criteria above specified limits: total bilirubin above 1,5 times the upper limit of normal (ULN), excluding patients with Gilbert's syndrome; aspartate (AST)/Glutamate Oxaloacétique Transaminase (SGOT) or alanine aminotransferase (ALT)/Glutamate Pyruvate Transaminase (SGPT), (AST/SGOT or ALT/SGPT) \>3 × ULN; alkaline phosphatase \>2.5 × ULN;
- Creatinine clearance (CrCl\<30) mL/min, calculated using the Cockcroft-Gault formula at screening
- Current treatment with Nintedanib or past treatment with Nintedanib in the last 12 months;
- Current treatment with Fluvoxamine or past treatment with Fluvoxamine in the last 28 days before screening
- Prior use of Pirfenidone or known hypersensitivity to any of the components of study treatment;
- Expected to receive a lung transplant within 1 year from randomization or, on a lung transplant waiting list at randomization;
- Associated connective tissue disease (such as systemic sclerosis).;
- Electrocardiogram (ECG), with a heart-rate-corrected QT interval (corrected using Fridericia's formula, QTcF) ≥ 500 ms at Screening, or a family or personal history of long QT syndrome;
- Treatment with Cyclophosphamide in the last 3 months;
- Current smoking or past smoking in the last 3 months.
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03385668
Start Date
January 31 2018
End Date
July 24 2020
Last Update
November 20 2025
Active Locations (1)
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1
Cochin Hospital
Paris, France, 75014