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A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00799578
First Posted: December 1, 2008
Last Update Posted: January 31, 2014
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:
Raptor Pharmaceuticals Corp.
Information provided by (Responsible Party):
Joel Lavine, University of California, San Diego
  Purpose
The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.

Condition Intervention Phase
Fatty Liver Drug: Cysteamine Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Joel Lavine, University of California, San Diego:

Primary Outcome Measures:
  • Normalization or >50% of Serum ALT Levels From Baseline [ Time Frame: 6 months ]

Enrollment: 13
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cystagon-EC Drug: Cysteamine
Drug is in enteric-coated capsule form. The dosage will begin at 1g/m-squared body surface area with a maximum dose of 1000mg twice daily. Treatment period is 3-6 months.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed diagnosis of non-alcoholic steatohepatitis (within past 12 months)
  • Ages 10 yrs and older
  • Must swallow tablets on a regular basis
  • ALT level >60 iu/L

Exclusion Criteria:

  • Subjects with known hypersensitivity to cysteamine
  • History, currently or within the past 3 months, of the following conditions:
  • Pancreatitis
  • Inflammatory bowel disease
  • Malabsorption
  • Unstable heart disease, e.g., myocardial infarction, heart failure, arrhythmias.
  • Unstable diabetes mellitus
  • Any bleeding disorder.
  • Zollinger-Ellison syndrome
  • Malignant disease
  • Subjects whom maybe pregnant or have health issues that make it unsafe for them participate, or whose concomitant medical problems preclude them from committing to the study schedule.
  • No specific NASH medical therapy for 3 months such as vitamin E, s-adenosyl methionine or metformin or other NAFLD study drugs.
  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): NCT00799578


Locations
United States, California
University of California, San Diego School of Medicine General Clinic Research Center
San Diego, California, United States, 92103-8203
Sponsors and Collaborators
Joel Lavine
Raptor Pharmaceuticals Corp.
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joel Lavine, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00799578     History of Changes
Other Study ID Numbers: 07-1699
First Submitted: November 28, 2008
First Posted: December 1, 2008
Results First Submitted: December 13, 2013
Results First Posted: January 31, 2014
Last Update Posted: January 31, 2014
Last Verified: December 2013

Keywords provided by Joel Lavine, University of California, San Diego:
NASH, NAFLD,nonalcoholic steatohepatitis

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Cysteamine
Cystine Depleting Agents
Molecular Mechanisms of Pharmacological Action