Status:
WITHDRAWN
A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis
Lead Sponsor:
Galmed Pharmaceuticals Ltd
Collaborating Sponsors:
Virginia Commonwealth University
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis
Detailed Description
The objectives of this study are to: * Establish the safety and tolerability of once daily (QD) Aramchol meglumine in patients with PSC * Examine whether once daily (QD) Aramchol meglumine has any ef...
Eligibility Criteria
Inclusion
- Male or female age 18 years and above (inclusive at first screening visit)
- Established diagnosis of large duct PSC based on abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP) or Endoscopic retrograde cholangiopancreatography (ERCP)
- Alkaline phosphatase \> 150 IU/l
- Stable inflammatory bowel disease therapy \> 3months for IBD patients
- If receiving treatment with Ursodeoxycholic acid (UDCA; ursodiol), therapy is at a dose of \<20 mg/kg/day, has been stable for at least 6 months before screening
- Ability to understand the nature of the study and to sign a written informed consent form (ICF)
Exclusion
- Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
- Active Crohn's disease (CDAI \> 40) or ulcerative colitis (Mayo IBD score \> 4) or active non-hemorrhoidal rectal bleeding
- Small bowel resection \> 100 cm
- Cirrhosis (clinically evident or by biopsy)
- Prior hepatic decompensation event
- Recent (\< 6 weeks) acute cholangitis or hospitalization for PSC or IBD
- Bleeding diathesis or other contraindication for liver biopsy
- Known GI or hepatobiliary malignancy
- Prior liver transplantation
- Prior exposure to study drug
- Active untreated viral hepatitis or other concomitant liver disease
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06095986
Start Date
June 1 2025
End Date
December 1 2027
Last Update
June 12 2025
Active Locations (1)
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1
The Sanyal Institute for Liver Disease & Metabolic Health at VCU
Richmond, Virginia, United States, 23284