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Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by University of California, San Diego.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01066364
First Posted: February 10, 2010
Last Update Posted: February 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo, Inc.
Information provided by:
University of California, San Diego
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Insulin sensitivity as determined by HOMA-IR [ Time Frame: 24 weeks ]
  • Serum ALT and AST values [ Time Frame: 24 weeks ]
  • Lipid profiles [ Time Frame: 24 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at entry at least 18 years.
  2. 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.
  3. Evidence of hepatic steatosis or liver fat (>5%) by MRI.
  4. Evidence of definite or suspected NASH
  5. Written informed consent.

Exclusion criteria:

  1. Evidence of another form of liver disease.
  2. History of excess alcohol ingestion.
  3. Contraindications to liver biopsy.
  4. Decompensated liver disease.
  5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
  6. Recent initiation or change of anti-diabetic drugs.
  7. Use of colesevelam or other agents in the same class.
  8. 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.
  9. Positive test for anti-HIV.
  10. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
  11. Pregnancy or inability to practice adequate contraception in women of childbearing potential.
  12. Evidence of hepatocellular carcinoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 8, 2010
First Posted: February 10, 2010
Last Update Posted: February 10, 2010
Last Verified: February 2010

Keywords provided by University of California, San Diego:
NASH
NAFLD
Steatohepatitis
Nonalcoholic
Fatty Liver Disease

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents


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