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NCT03678480
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
Withdrawn
Phase 2
Last updated 15 February 2021
What this trial tests
Phase 2 trial testing HTD1801 in Primary Sclerosing Cholangitis. Withdrawn.
Timeline
1 March 2021
Primary endpoint
4 October 2021
4 October 2021
4 November 2021
Quick facts
| Lead sponsor | HighTide Biopharma Pty Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 1 March 2021 |
| Primary completion | 4 October 2021 |
| Estimated completion | 4 November 2021 |
Drugs / interventions tested
- HTD1801 — full drug profile →
- Ursodeoxycholic Acid — full drug profile →
Conditions studied
- Primary Sclerosing Cholangitis — all drugs for Primary Sclerosing Cholangitis →
- Cholangitis — all drugs for Cholangitis →
- Cholangitis, Sclerosing — all drugs for Cholangitis, Sclerosing →
- Bile Duct Diseases — all drugs for Bile Duct Diseases →
Sponsor
HighTide Biopharma Pty Ltd — full company profile →
Who can join
Adults 12 to 17, any sex, with Primary Sclerosing Cholangitis or Cholangitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Management of Cholestatic Liver Diseases: Current Therapies and Emerging New Possibilities.
Mazzetti M, Marconi G, Mancinelli M, Benedetti A, et al · · 2021 · cited 17× · PMID 33919600 · DOI 10.3390/jcm10081763 -
An overview of recent treatment options for primary sclerosing cholangitis.
Mousavere I, Kalampokis G, Fousekis F, Karayiannis P, et al · · 2023 · cited 8× · PMID 38023975 · DOI 10.20524/aog.2023.0834
Verify or expand the search:
- PubMed search for NCT03678480
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HTD1801
Trials testing the same drug.
- NCT07496177 — A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chro · Phase 2 · not yet recruiting
- NCT06415773 — Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Contr · Phase 3 · completed
- NCT06353347 — Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled Wit · Phase 3 · completed
- NCT06350890 — Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes · Phase 3 · completed
- NCT05623189 — HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes · Phase 2 · completed
Other recruiting trials for Primary Sclerosing Cholangitis
Currently open trials in the same condition.
- NCT07229911 — A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC) · Phase 1 · recruiting
- NCT06905054 — Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation · Phase 2 · recruiting
- NCT06455280 — A Study of SIPLIZUMAB in AILD and LT Patients · Phase 1 · recruiting
- NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome · recruiting
- NCT06351696 — The Effects of Bromelain Supplement in Patients With Ulcerative Colitis · NA · recruiting
Other HighTide Biopharma Pty Ltd trials
Trials by the same sponsor.
- NCT06415773 — Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Contr · Phase 3 · completed
- NCT06353347 — Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled Wit · Phase 3 · completed
- NCT06350890 — Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes · Phase 3 · completed
- NCT05623189 — HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes · Phase 2 · completed
- NCT06411275 — A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Di · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03678480 (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 HighTide Biopharma Pty Ltd
- Last refreshed: 15 February 2021
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/NCT03678480.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing