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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
Results First Submitted: December 13, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Fatty Liver
Intervention: Drug: Cysteamine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Biopsy proven children with nonalcoholic fatty liver disease from fatty liver clinic at University of California, San Diego

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not on other therapy for NAFLD

Reporting Groups
  Description
Cystagon-EC No text entered.

Participant Flow:   Overall Study
    Cystagon-EC
STARTED   13 
COMPLETED   11 
NOT COMPLETED   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cystagon-EC No text entered.

Baseline Measures
   Cystagon-EC 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   13 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 14  (1) 
Gender 
[Units: Participants]
 
Female   1 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Joel Lavine
Organization: Columbia University
phone: 212 304 5533
e-mail: jl3553@columbia.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joel Lavine, 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