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NCT02141087

Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

APPROVED FOR MARKETING Last updated 13 July 2015
What this trial tests

trial testing Pirfenidone in Idiopathic Pulmonary Fibrosis. Approved for marketing.

Quick facts

Lead sponsorGenentech, Inc.
StatusAPPROVED FOR MARKETING
Study typeEXPANDED_ACCESS

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of Pirfenidone

Trials testing the same drug.

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

Other Genentech, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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