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NCT05939947: FEGATO-01
A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis
Phase 1 trial testing ALE.F02 in Advanced Liver Fibrosis in 41 participants. Completed in 30 October 2024.
30 October 2024
Quick facts
| Lead sponsor | Alentis Therapeutics AG |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 41 |
| Start date | 1 April 2023 |
| Primary completion | 30 October 2024 |
| Estimated completion | 30 October 2024 |
| Sites | 6 locations across Romania, Slovakia, United States, Germany |
Drugs / interventions tested
- ALE.F02 — full drug profile →
- Placebo
Conditions studied
- Advanced Liver Fibrosis — all drugs for Advanced Liver Fibrosis →
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
Sponsor
Alentis Therapeutics AG — full company profile →
Who can join
Adults 18 to 80, any sex, with Advanced Liver Fibrosis or Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exploring the Critical Role of Tight Junction Proteins in Kidney Disease Pathogenesis.
Jayne D, Herbert C, Anquetil V, Teixeira G. · · 2025 · cited 4× · PMID 39532075 · DOI 10.1159/000542498 -
Translating Fibrosis to Malignancy: Biomarkers and Therapeutic Opportunities in Liver Fibrosis and Hepatocellular Carcinoma.
Neureiter D, Kiesslich T, Ocker M. · · 2026 · PMID 41892825 · DOI 10.3390/medsci14010110
Verify or expand the search:
- PubMed search for NCT05939947
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ALE.F02
Trials testing the same drug.
- NCT06047171 — Rescue of Nephrons With ALE.F02 (RENAL-F02) · Phase 2 · recruiting
Other Alentis Therapeutics AG trials
Trials by the same sponsor.
- NCT07169734 — A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06747585 — A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06054477 — Study of ALE.C04 in Patients With Head and Neck Cancer · Phase 1, PHASE2 · terminated
- NCT06047171 — Rescue of Nephrons With ALE.F02 (RENAL-F02) · Phase 2 · 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 NCT05939947 (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 Alentis Therapeutics AG
- Last refreshed: 3 December 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/NCT05939947.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing