EUCTR2018-003365-34-IT
Active, not recruiting
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA. - na
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 sites2 target enrollmentAugust 3, 2021
ConditionsPrimary Biliary CholangitisMedDRA version: 20.0Level: PTClassification code 10008604Term: CholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsOlumiant
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary Biliary Cholangitis
- Sponsor
- ELI LILLY & COMPANY, LILLY CORPORATE CENTER
- Enrollment
- 2
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type of Patient and Disease Characteristics
- •\[1] Male or female patients who are at least 18 years of age.
- •\[2] Have a diagnosis of PBC (consistent with American Association for
- •the Study of Liver Disease \[AASLD] and European Association for Study
- •of the Liver \[EASL]
- •Practice Guidelines; \[Lindor 2009; EASL 2017]), as demonstrated by the
- •presence of at least 2 of the following 3 diagnostic factors:
- •¿ History of elevated ALP levels for at least 6 months
- •¿ Positive antimitochondrial antibodies titer
- •¿ Liver biopsy consistent with PBC
Exclusion Criteria
- •\[7] History or presence of other concomitant liver diseases including:
- •a. Hepatitis C virus (HCV) infection (hepatitis C antibody\-positive and
- •HCV ribonucleic acid \[RNA] positive). ¿ Note: Patients who have
- •documented anti\-HCV treatment for a past HCV infection AND are HCV
- •RNA\-negative with a sustained viral response may be enrolled in the
- •b. Hepatitis B virus (HBV) infection defined as:
- •¿ positive for hepatitis B surface antigen (HBsAg), or
- •¿ positive for hepatitis B core antibody (HBcAb)
- •c. Primary sclerosing cholangitis
- •d. Alcoholic liver disease
Outcomes
Primary Outcomes
Not specified
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