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NCT02141087
Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone
trial testing Pirfenidone in Idiopathic Pulmonary Fibrosis. Approved for marketing.
Quick facts
| Lead sponsor | Genentech, Inc. |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
Drugs / interventions tested
- Pirfenidone — full drug profile →
Conditions studied
- Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
Sponsor
Genentech, Inc. — full company profile →
Who can join
18 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open label multi-center program to allow patients in the US with IPF access to treatment with pirfenidone.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis.
Lancaster LH, de Andrade JA, Zibrak JD, Padilla ML, et al · · 2017 · cited 192× · PMID 29212837 · DOI 10.1183/16000617.0057-2017 -
Dose modification and dose intensity during treatment with pirfenidone: analysis of pooled data from three multinational phase III trials.
Nathan SD, Lancaster LH, Albera C, Glassberg MK, et al · · 2018 · cited 36× · PMID 30116539 · DOI 10.1136/bmjresp-2018-000323 -
Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Experience from 92 Sites in an Open-Label US Expanded Access Program.
Lancaster L, Morrison L, Auais A, Ding B, et al · · 2017 · cited 12× · PMID 32026347 · DOI 10.1007/s41030-017-0049-z
Verify or expand the search:
- PubMed search for NCT02141087
- 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.
- NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
- NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
- NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
- NCT06485635 — Real-life-persistence to Antifibrotic Treatments · completed
- NCT06484153 — Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcin · Phase 1, PHASE2 · not yet recruiting
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 Genentech, Inc. trials
Trials by the same sponsor.
- NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
- NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas · Phase 2 · recruiting
- NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
- NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
- NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting
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 NCT02141087 (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 Genentech, Inc.
- Last refreshed: 13 July 2015
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/NCT02141087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing