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

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fatty Liver
Intervention Drug: Cysteamine
Enrollment 13
Recruitment Details Biopsy proven children with nonalcoholic fatty liver disease from fatty liver clinic at University of California, San Diego
Pre-assignment Details Not on other therapy for NAFLD
Arm/Group Title Cystagon-EC
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Arm/Group Title Cystagon-EC
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
13
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
14  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
1
   7.7%
Male
12
  92.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Normalization or >50% of Serum ALT Levels From Baseline
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Number of Improved Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Number of Improved Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Number of Improved Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Number of Improved Subjects
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Number of Improved Subjects
Affected / at Risk (%)
Total   0/13 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Joel Lavine
Organization: Columbia University
Phone: 212 304 5533
EMail: jl3553@columbia.edu
Publications:
Layout table for additonal information
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