Trials / Completed
CompletedNCT01903460
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Paediatric Patients With Alagille Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Mirum Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Months – 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and pruritus associated with Alagille Syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUM001 | |
| DRUG | Placebo |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2015-02-01
- Completion
- 2015-03-01
- First posted
- 2013-07-19
- Last updated
- 2019-03-28
- Results posted
- 2015-12-07
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01903460. Inclusion in this directory is not an endorsement.