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Trial record 20 of 32 for:    CYSTEAMINE

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

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. Identifier: NCT00799578
Recruitment Status : Completed
First Posted : December 1, 2008
Results First Posted : January 31, 2014
Last Update Posted : January 31, 2014
Raptor Pharmaceuticals Corp.
Information provided by (Responsible Party):
Joel Lavine, University of California, San Diego

Brief Summary:
The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: Cysteamine Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00799578

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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.

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joel Lavine, Professor, University of California, San Diego Identifier: NCT00799578     History of Changes
Other Study ID Numbers: 07-1699
First Posted: December 1, 2008    Key Record Dates
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:
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Fatty Liver
Liver Diseases
Digestive System Diseases
Cystine Depleting Agents
Molecular Mechanisms of Pharmacological Action