A Phase 2 interventional study of Pirfenidone in Pulmonary Fibrosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Among 11 studies testing pirfenidone in Pulmonary Fibrosis — 2 open to participants now, 3 under way, 2 of them phase 3. pirfenidone · Pulmonary Fibrosis.
Among the 11 studies testing pirfenidone in Pulmonary Fibrosis, this one is the 11th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 2, and was the 6th registered.
342 studies on the registry are indexed under Pulmonary Fibrosis; 98 are open to participants now.
This study's enrollment of 7 is below the median of 59 across 212 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →2 of the 11 studies testing pirfenidone in Pulmonary Fibrosis are open now, in 4 countries. Each count lists the studies.
pirfenidone: first FDA approval 2014 (ESBRIET), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 71 Pulmonary Fibrosis studies recruiting now, 41 (58%) set no upper age limit and 4 (6%) stop at 75 or younger; 8 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2018.
Median enrollment 83 across the 11 interventional studies. Of the 6 that completed or were terminated, 3 (50%) have results posted.
6 of 11 have an industry lead sponsor. The 9 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 5 studies filed under Pulmonary Fibrosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing pirfenidone in Pulmonary Fibrosis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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 associated vasculitis.
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. The pathophysiology of this association remains unclear. Conventional therapies used for the treatment of vasculitis manifestations are often disappointing for the treatment of pulmonary fibrosis. The main cause of death in patients with anti-MPO ANCA associated vasculitis and associated pulmonary fibrosis is the progression of pulmonary fibrosis. No treatment has demonstrated efficacy to stabilize or improve pulmonary fibrosis associated with anti-MPO associated vasculitis.
Previous studies showed that Pirfenidone improves survival and pulmonary function in patients with idiopathic pulmonary fibrosis (IPF) and that Pirfenidone treatment is safe and well tolerated in IPF. Patients with anti-MPO associated vasculitis (or anti-MPO antibodies without vasculitis) and associated pulmonary fibrosis might benefit from the use of Pirfenidone. However, the efficacy and safety of pirfenidone in patients with anti-MPO associated vasculitis and associated pulmonary fibrosis has not been evaluated. This study was designed to assess the efficacy and safety of pirfenidone in patients with pulmonary fibrosis and anti-MPO ANCA associated vasculitis or anti-MPO antibodies without vasculitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive Pirfenidone
Drug: Pirfenidone
Pirfenidone at a dose of 2403 mg/day for 50 weeks, after a 2 weeks period of titration (801 mg/day for one week then 1602 mg/day for one week).
Treatment efficacy measured by the absolute change in percent predicted forced vital capacity (%FVC)
Treatment efficacy at Week 52 measured by the absolute change from baseline to Week 52 in percent predicted forced vital capacity (%FVC) : * Patients with progressive disease will be defined as absolute decline of 10% or more in %FVC. Missing values or death will be also considered as progressive. * Patients with non-progressive disease will be defined as improvement or no decline in %FVC or a decline of %FVC\<10%.
Time frame: 52 weeks
Adverse Events (AE)
Safety parameters reported in the period from baseline to 28 days after the last dose of the study drug: * Treatment-emergent AEs * Treatment-emergent Serious Adverse Events (SAE) * Treatment emergent Adverse Event of Special Interest (AESI) * Treatment-emergent treatment-related AEs * Treatment-emergent treatment-related SAEs * Treatment emergent related AESIs * AEs leading to early discontinuation of study treatment * Treatment-emergent deaths * Cause of death * Treatment-emergent changes in clinical laboratory findings * Vital signs
Time frame: 56 weeks corresponding to 28 days after the last dose of study drug
Treatment efficacy measured by the absolute change in percent predicted forced vital capacity (%FVC)
Treatment efficacy at Week 24 measured by the absolute change from baseline to Week 24 in percent predicted forced vital capacity (%FVC) : * Patients with progressive disease will be defined as absolute decline of 10% or more in %FVC. Missing values or death will be also considered as progressive. * Patients with non-progressive disease will be defined as improvement or no decline in %FVC or a decline of %FVC\<10%.
Time frame: 24 weeks
Relative change in in percent predicted forced vital capacity
Relative change from baseline to Week 52 in percent predicted forced vital capacity (%FVC)
Time frame: 52 weeks
Absolute change in in percent predicted forced vital capacity
Relative and absolute change from baseline to Week 52 in percent predicted forced vital capacity (%FVC)
Time frame: 52 weeks
Relative change in in percent predicted forced vital capacity
Relative and absolute change from baseline to Week 24 in percent predicted forced vital capacity (%FVC)
Time frame: 24 weeks
Absolute change in in percent predicted forced vital capacity
Relative and absolute change from baseline to Week 24 in percent predicted forced vital capacity (%FVC)
Time frame: 24 weeks
Six minute walk test (6MWT) distance
Change from Baseline to Week 52 in the six minute walk test (6MWT) distance
Time frame: 52 weeks
Six minute walk test (6MWT) distance
Change from Baseline to Week 24 in the six minute walk test (6MWT) distance
Time frame: 24 weeks
Carbon Monoxide Diffusing Capacity (%DLCO)
Change from Baseline to Week 52 in the percent predicted Carbon Monoxide Diffusing Capacity (%DLCO)
Time frame: 52 weeks
Carbon Monoxide Diffusing Capacity (%DLCO)
Change from Baseline to Week 24 in the percent predicted Carbon Monoxide Diffusing Capacity (%DLCO)
Time frame: 24 weeks
Progression-free survival
Progression-free survival defined as the time to the first occurrence of any one of the following: a confirmed decrease of 10 percentage points or more in %FVC, a confirmed decrease of 15 percentage points or more in %DLCO, or death.
Time frame: 52 weeks
Dyspnea
Change from Baseline to Week 52 in dyspnea as measured by the New York Heart Association classification, the modified Borg scale and by the Saint-George's Respiratory Questionnaire (SGRQ).
Time frame: 52 weeks
Chest CT-scan
Change in Chest-CT scan abnormalities at Week 52 (evaluated after a centralized blinded review of the chest CT-scans).
Time frame: 52 weeks
Quality of Life assessed by the Health Assessment Questionnaire (HAQ)
Time frame: 52 weeks
Quality of Life assessed by the Short Form-36 (SF-36)
Time frame: 52 weeks
Plan to share: No
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pirfenidone
Assistance Publique - Hôpitaux de Paris →