Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
This study is enrolling participants by invitation only.
Sponsor:
University of California, San Diego
Collaborator:
Daiichi Sankyo Inc.
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01066364
First received: February 8, 2010
Last updated: February 9, 2010
Last verified: February 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
| Condition | Intervention | Phase |
|---|---|---|
|
Nonalcoholic Steatohepatitis |
Drug: Colesevelam Hcl |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis |
Resource links provided by NLM:
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- The primary outcome will be improvement in hepatic steatosis by liver MRI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Insulin sensitivity as determined by HOMA-IR [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Serum ALT and AST values [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Lipid profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo (sugar) pill
Six tablets per day (identical to colesevelam)
|
Drug: Colesevelam Hcl
3.75 gm/day (six 675 mg tablets)
Other Name: Welchol
|
|
Experimental: Colesevelam arm
3.75 grams per day
|
Drug: Colesevelam Hcl
3.75 gm/day (six 675 mg tablets)
Other Name: Welchol
|
Detailed Description:
We plan to investigate the role of colesevelam, a bile-acid binding resin, in patients with NASH residing in the United States and assess liver fat changes during therapy using MRI of the liver. It can be hypothesized that colesevelam would lead to a greater improvement in insulin sensitivity and lipid profile compared with placebo and may lead to greater improvement in liver fat by MRI as compared to placebo.
In this pilot study, we propose to randomize approximately 55 patients (1:1 ratio) to either colesevelam or placebo and treat them for 24-weeks to evaluate changes in baseline insulin sensitivity, serum biochemistry (ALT and AST), and liver fat by MRI during therapy. Liver histologic changes would also be examined as an exploratory outcome for future studies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age at entry at least 18 years.
- Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.
- Evidence of hepatic steatosis or liver fat (>5%) by MRI.
- Evidence of definite or suspected NASH
- Written informed consent.
Exclusion criteria:
- Evidence of another form of liver disease.
- History of excess alcohol ingestion.
- Contraindications to liver biopsy.
- Decompensated liver disease.
- History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
- Recent initiation or change of anti-diabetic drugs.
- Use of colesevelam or other agents in the same class.
- Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.
- Positive test for anti-HIV.
- Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
- Pregnancy or inability to practice adequate contraception in women of childbearing potential.
- Evidence of hepatocellular carcinoma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066364
Locations
| United States, California | |
| UCSD: Prevention Studies Clinic | |
| La Jolla, California, United States, 92093 | |
| UCSD: Medical Center- Hillcrest | |
| San Diego, California, United States, 92103 | |
Sponsors and Collaborators
University of California, San Diego
Daiichi Sankyo Inc.
Investigators
| Principal Investigator: | Rohit Loomba, MD, M.H.Sc | University of California, San Diego |
More Information
No publications provided
| Responsible Party: | Rohit Loomba, MD, M.H.Sc, UCSD: Gastroenterology- Dept of Medicine, Epidemiology- Dept of Family and Preventive Medicine |
| ClinicalTrials.gov Identifier: | NCT01066364 History of Changes |
| Other Study ID Numbers: | 091491 |
| Study First Received: | February 8, 2010 |
| Last Updated: | February 9, 2010 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by University of California, San Diego:
|
NASH NAFLD Steatohepatitis Nonalcoholic Fatty Liver Disease |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases Colesevelam Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013