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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 October 2023 |
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Main ID: |
NCT05293938 |
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Date of registration:
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04/03/2022 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
HEROES-PBC |
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Scientific title:
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Study Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis |
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Date of first enrolment:
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March 28, 2022 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05293938 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Lynda Szczech, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Intercept Pharmaceuticals |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
1. Definite or probable PBC diagnosis
2. UDCA failure
3. Age =18 years at the index date
4. Evaluable data for at least 12 months before the index date (inclusive)
Key Exclusion Criteria:
1. History or presence of other concomitant liver diseases
2. Patients with laboratory values indicative of hepatic decompensation or significant
hepatobiliary injury
3. History of liver transplant
4. Evidence of OCA, fenofibrate, or bezafibrate use
5. History or presence of hepatic decompensating events
6. Participation in a clinical trial for a PBC medication
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cholangitis
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Intervention(s)
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Drug: Standard of Care: UDCA
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Drug: Obeticholic Acid 5 MG
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Drug: Obeticholic Acid 10 MG
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Primary Outcome(s)
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Time to the first occurrence of the composite endpoint of all-cause death, liver transplant, or hepatic decompensation.
[Time Frame: Time from index date to first occurrence of the composite endpoint events, assessed up to 62 months.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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