Trials / Withdrawn
WithdrawnNCT03678480
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- HighTide Biopharma Pty Ltd · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
Conditions
- Primary Sclerosing Cholangitis
- Cholangitis
- Cholangitis, Sclerosing
- Bile Duct Diseases
- Biliary Tract Diseases
- Digestive System Diseases
- Adolescent
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTD1801 | HTD1801 capsules, 250mg |
| DRUG | Ursodeoxycholic Acid | UDCA capsules, 125mg |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2021-10-04
- Completion
- 2021-11-04
- First posted
- 2018-09-19
- Last updated
- 2021-02-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03678480. Inclusion in this directory is not an endorsement.