Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

This study is enrolling participants by invitation only.
Sponsor:
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
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Liver Diseases
Colesevelam
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014