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NCT07104201
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
EARLY_PHASE1 trial testing Fenofibrate in Primary Biliary Cholangitis (PBC) in 15 participants. Currently enrolling.
1 March 2035
Quick facts
| Lead sponsor | Xijing Hospital of Digestive Diseases |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 13 March 2025 |
| Primary completion | 1 March 2035 |
| Estimated completion | 1 March 2035 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fenofibrate (FENOFIBRATE) — full drug profile →
Conditions studied
- Primary Biliary Cholangitis (PBC) — all drugs for Primary Biliary Cholangitis (PBC) →
Sponsor
Xijing Hospital of Digestive Diseases
Who can join
Adults 18 to 75, any sex, with Primary Biliary Cholangitis (PBC). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Treatment emergent adverse events (TEAEs)
Time frame: Through study completion, up to 120 Months
Sponsor's own description
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07104201
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fenofibrate
Trials testing the same drug.
- NCT07296458 — FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy · Phase 3 · recruiting
- NCT06858332 — Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia · recruiting
- NCT06191133 — Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma · Phase 1 · recruiting
- NCT06591455 — A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis · EARLY_PHASE1 · completed
- NCT06155331 — Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Br · Phase 2 · completed
Other recruiting trials for Primary Biliary Cholangitis (PBC)
Currently open trials in the same condition.
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
- NCT07296458 — FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy · Phase 3 · recruiting
- NCT07149675 — PBC Long-term Outcomes Study · recruiting
- NCT07161245 — RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis · NA · recruiting
- NCT06016842 — A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
Other Xijing Hospital of Digestive Diseases trials
Trials by the same sponsor.
- NCT07401303 — Full-time RDI for ESD: Impact on Major Adverse Events and Procedure Time · NA · not yet recruiting
- NCT07296458 — FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy · Phase 3 · recruiting
- NCT07129460 — Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia · Phase 4 · not yet recruiting
- NCT07182890 — Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · recruiting
- NCT07187492 — Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · 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 NCT07104201 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital of Digestive Diseases
- Last refreshed: 3 August 2025
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/NCT07104201.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing