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Operational and clinical reasons
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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
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The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis
The objectives of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSC patients administered with Aramchol meglumine | Active Comparator | Adult subjects with clinically diagnosed PSC that are administered with Aramchol meglumine |
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| PSC patients administered with placebo | Placebo Comparator | Adult subjects with clinically diagnosed PSC that are administered with matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aramchol meglumine | Drug | Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in serum alkaline phosphatase (ALP) | The change from Baseline to Week 48 in ALP levels | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in hepatobiliary fibrosis using the Nakanuma staging scale | Change from Baseline to Week 48 in liver histology using the Nakanuma stage classification. A score of 0 is classified as stage 1 (no or minimal disease progression), while 1 score 5 or 6 is classified as stage 4 (advanced disease progression). | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Sanyal, MD | The Sanyal Institute for Liver Disease & Metabolic Health at VCU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sanyal Institute for Liver Disease & Metabolic Health at VCU | Richmond | Virginia | 23284 | United States |
Share the study protocol and SAP
Study completion
Any person with access to ClinicalTrials.gov
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| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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Parallel group analysis
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Double-blind
| Change from Baseline in Enhanced liver fibrosis (ELF) |
Change from Baseline to Week 48 in Enhanced liver fibrosis (ELF) test. Score below 7.7 indicate no to mild fibrosis, and score higher than 11.3 indicate cirrhosis. |
| 48 weeks |
| Change from Baseline in MRCP | Change from Baseline to Week 48 in magnetic resonance cholangiopancreatography (MRCP) | 48 weeks |
| Change from Baseline in quantitative liver function using Gadoxetate clearance | Change from Baseline to Week 48 in quantitative liver function using Gadoxetate clearance | 48 weeks |
| Change from Baseline in 5D-itch scale | Change from Baseline to Week 48 in the 5 dimension itch scale (5d-itch scale) measuring pruritus (the 5 dimensions are degree, duration, direction, disability and distribution). Higher degree mean worse outcome <8 on rating scale mean no pruritus, and >22 on rating scale indicate severe pruritus | 48 weeks |
| Change from Baseline to Week 48 in Patient-Reported Outcomes Measurement Information System (PROMIS)-19 score | Change from Baseline to Week 48 in the Patient-Reported Outcomes Measurement Information System (PROMIS)-19 questionnaire score. The average score for Physical Function is 50, with a score of 40 considered below average and a score of 60 considered above average | 48 weeks |
| Change from Baseline in the Mayo IBD symptom severity score | Change from Baseline to Week 48 in the Mayo Inflammatory bowel disease (IBD) symptom severity score. A score of 3 to 5 points indicates mildly active disease and a score of 11 to 12 points indicates severely active bowel disease | 48 weeks |
| Change from Baseline in the revised Mayo risk score (rMRS) | Change from Baseline to Week 48 in the revised Mayo risk score (rMRS). The score provide the estimated probability of survival (%) based on age, bilirubin, AST, and history of bleeding | 48 weeks |
| Change from Baseline in the UK-PSC score | Change from Baseline to Week 48 in the united kingdom primary sclerosing cholangitis (UK-PSC) score. The score provide the estimated probability of survival (%) based on age, bilirubin, albumin, platelets, hemoglobin and ALP | 48 weeks |
| Change from Baseline in the PSC risk estimate tool (PREsTo) | Change from Baseline to Week 48 in the PSC risk estimate tool (PREsTo). The tool consists of bilirubin, albumin, ALP, platelets, AST, hemoglobin, sodium, patient age and the number of years since PSC was diagnosed, and it predicts short-term and long-term need for liver transplantation or death. | 48 weeks |