Trial Profile
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis
Status:
Discontinued
Phase of Trial:
Phase III/IV
Latest Information Update: 06 Mar 2024
Price :
$35
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At a glance
- Drugs Obeticholic acid (Primary)
- Indications Primary biliary cirrhosis
- Focus Registrational; Therapeutic Use
- Acronyms COBALT
- Sponsors Intercept Pharmaceuticals
- 29 Feb 2024 According to an Intercept Pharmaceuticals media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Ocaliva for the treatment of PBC. The sNDA is supported by data from the Company's post-marketing requirement studies COBALT and Study 401 as well as real-world evidence from a U.S. claims database and international PBC patient registries. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target
- 14 Nov 2023 Results exploring the issues of Recruitment and retention using COBALT phase 3b/4 confirmatory outcomes trial presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
- 14 Nov 2023 Results assessing Clinical Trial (COBALT study) and Real-World Outcomes (HEROES study) in Patients with Primary Biliary Cholangitis Treated with Obeticholic Acid presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases