Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Neurology Rheumatology Diabetes / Metabolic Mental Health / Psychiatry Women's Health Dermatology Men's Health Rare Diseases
Clinical Trial Active — Not Recruiting Phase III NCT06383403

A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. — Active Not Recruiting • Phase III • Gastroenterology •…

📅 30 Apr 2026 ⏱ 2 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT06383403
Start
2024-07-09
Completion
2026-06-26
ClinicaliQ Trial Snapshot
  • A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. — Active Not Recruiting • Phase III • Gastroenterology • NCT06383403.
  • Trial testing elafibranor versus placebo in primary biliary cholangitis patients who cannot tolerate or inadequately respond to ursodeoxycholic acid, measuring effects on alkaline phosphatase levels.

Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a liver transplant or may…

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Clinical Brief
‘We have to respond to women’s health needs more easily’
Gastroenterology · BBC Health · 11 May 2026
Women's Health Initiative - Key Takeaways Liverpool-based groups are addressing long-standing gaps in women's healthcare provision, highlighting systemic under-resourcing that requires urgent…
View brief →
Guideline
Cirrhosis in Over 16s: Assessment and Management (NICE NG50)
Gastroenterology · 27 Mar 2026
Perform upper endoscopy to screen all cirrhosis patients for oesophageal varices; if present, offer variceal band ligation and initiate non-selective beta-blockers (propranolol…
View guideline →
Guideline
Hepatitis B (Chronic): Diagnosis and Management (NICE NG133)
Gastroenterology · 27 Mar 2026
Assess all newly diagnosed chronic hepatitis B patients with HBsAg, anti-HBc, HBeAg, anti-HBe, quantitative HBV DNA, ALT, and liver function tests before…
View guideline →
Clinical Brief
Taskforce set up to deliver urgent action on maternity
Gastroenterology · NHS England · 17 Mar 2026
Members confirmed for new Maternity and Neonatal Taskforce chaired by the Health and Social Care Secretary to deliver improvements on maternity. This…
View brief →
Clinical Brief
UKHSA and Stablepharma highlight breakthrough with fridge-free tetanus and diphtheria vaccine
Gastroenterology · UKHSA · 13 Mar 2026
Stablepharma has developed a thermostable tetanus and diphtheria vaccine requiring no cold-chain storage, addressing a critical logistical barrier to immunisation in resource-limited…
View brief →
Clinical Brief
Prince William praises £20m milestone for Bowelbabe fund
Gastroenterology · BBC Health · 02 Apr 2026
The Bowelbabe fund, established by Dame Deborah James in 2022, has reached a £20 million fundraising milestone to support Cancer Research UK's…
View brief →