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NCT06267794: ODISEA
Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis.
Phase 2 trial testing Pirfenidone 1200 mg in Liver Fibrosis in 180 participants. Completed in 24 March 2023.
30 December 2021
Quick facts
| Lead sponsor | Jorge L Poo |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 26 June 2015 |
| Primary completion | 30 December 2021 |
| Estimated completion | 24 March 2023 |
Drugs / interventions tested
- Pirfenidone 1200 mg — full drug profile →
- Pirfenidone 1800 mg — full drug profile →
- Placebo
Conditions studied
- Liver Fibrosis — all drugs for Liver Fibrosis →
- Cirrhosis, Liver — all drugs for Cirrhosis, Liver →
- Chronic Liver Disease — all drugs for Chronic Liver Disease →
Sponsor
Jorge L Poo — full company profile →
Who can join
Adults 18 to 80, any sex, with Liver Fibrosis or Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Liver cirrhosis: molecular mechanisms and therapeutic interventions.
Dong Z, Wang Y, Jin W. · · 2024 · cited 13× · PMID 39290252 · DOI 10.1002/mco2.721 -
Decoding organ fibrosis: mechanistic insights and emerging therapeutic strategies.
Chen X, Zhang J, Guo L, Wu C, et al · · 2026 · cited 2× · PMID 41786685 · DOI 10.1038/s41392-025-02532-0
Verify or expand the search:
- PubMed search for NCT06267794
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pirfenidone 1200 mg
Trials testing the same drug.
- NCT06585319 — Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19 · Phase 2, PHASE3 · completed
Other recruiting trials for Liver Fibrosis
Currently open trials in the same condition.
- NCT07031089 — City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the · recruiting
- NCT06940375 — Incidence of Liver Disease-Related Outcomes in People With HIV · recruiting
- NCT07271576 — Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis · NA · recruiting
- NCT07069725 — The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Partic · Phase 1 · recruiting
- NCT07122700 — Evaluation of Non-Invasive Tests for Metabolic Liver Disease · 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 NCT06267794 (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 Jorge L Poo
- Last refreshed: 20 February 2024
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/NCT06267794.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing