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NCT02699879
Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
trial testing Pirfenidone in Idiopathic Pulmonary Fibrosis in 1,009 participants. Completed in 15 September 2016.
15 September 2016
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,009 |
| Start date | 16 February 2012 |
| Primary completion | 15 September 2016 |
| Estimated completion | 15 September 2016 |
| Sites | 106 locations across France, Denmark, Finland, Italy, Austria, Sweden, Ireland, United Kingdom |
Drugs / interventions tested
- Pirfenidone — full drug profile →
Conditions studied
- Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Eligibility, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study.
Cottin V, Koschel D, Günther A, Albera C, et al · · 2018 · cited 89× · PMID 30364407 · DOI 10.1183/23120541.00084-2018 -
Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies.
Behr J, Nathan SD, Costabel U, Albera C, et al · · 2023 · cited 11× · PMID 37391667 · DOI 10.1007/s12325-023-02565-3
Verify or expand the search:
- PubMed search for NCT02699879
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pirfenidone
Trials testing the same drug.
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- NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
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Other recruiting trials for Idiopathic Pulmonary Fibrosis
Currently open trials in the same condition.
- NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF · Phase 1 · recruiting
- NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
- NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc · Phase 1 · recruiting
- NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · recruiting
- NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
- NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
- NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
- NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02699879 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 21 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02699879.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing