Status:
COMPLETED
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
Lead Sponsor:
Mirum Pharmaceuticals, Inc.
Conditions:
Alagille Syndrome
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Diagnosis of Alagille Syndrome
- Evidence of cholestasis
- Moderate to severe pruritus
- Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures
Exclusion
- Surgical disruption of the enterohepatic circulation
- Liver transplant
- History or presence of other concomitant liver disease
- Females who are pregnant or lactating
- Known HIV infection
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01903460
Start Date
August 1 2013
End Date
March 1 2015
Last Update
March 28 2019
Active Locations (3)
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1
Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom, B4 6NH
2
Leeds Teaching Hospitals
Leeds, West Yorkshire, United Kingdom, LS9 7TF
3
Kings College Hospital
London, United Kingdom, SE5 9RS