EUCTR2018-003365-34-GB
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
ConditionsPrimary Biliary CholangitisMedDRA version: 20.0 Level: PT Classification code 10008604 Term: Cholangitis System 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 and Company
- Enrollment
- 52
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects will be eligible for randomization only if they meet all of the
- •following criteria within the screening period, which is \=49 days prior to randomization, unless
- •specifically defined:
- •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
Exclusion Criteria
- •Medical Conditions
- •\[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 study.
- •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
- •e. Autoimmune liver disease other than PBC, such as overlap hepatitis
- •f. Nonalcoholic steatohepatitis
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA.Primary Biliary CholangitisMedDRA version: 20.0Level: PTClassification code 10008604Term: CholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2018-003365-34-ITELI LILLY & COMPANY, LILLY CORPORATE CENTER2
Active, not recruiting
Phase 1
Investigation on the effect and tolerability of erenumab in trigeminal neuralgiaTrigeminal neuralgiaMedDRA version: 20.0Level: PTClassification code 10044652Term: Trigeminal neuralgiaSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2019-000848-95-DKDansk Hovedpine Center, Neurologisk Klinik, Rigshospitalet - Glostrup80
Active, not recruiting
Not Applicable
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - NDEUCTR2006-001958-27-ITELI LILLY1,265
Active, not recruiting
Phase 1
A randomized study to evaluate the efficacy of Tocilizumab to induce Remission and to spare Glucocorticoids in subjects with new-onset Polymyalgia Rheumatica.Polymyalgia rheumaticaPolymyalgia rheumatica is an inflammatory rheumatic disease that occurs primarily in the elderly with a peak incidence around 70 years of age. It is clinically characterized by shoulder girdle and hip pain and stiffness which impair raising arms and rising from a chair.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2016-004990-42-ATMedizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie36
Active, not recruiting
Phase 1
Study of a new therapeutic agent used to treat portopulmonary hypertensioPortopulmonary hypertensionMedDRA version: 20.0Level: PTClassification code 10067281Term: Portopulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2014-004624-21-CZACTELION Pharmaceuticals Ltd.84