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S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00475176
First Posted: May 21, 2007
Last Update Posted: July 5, 2013
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.
Information provided by (Responsible Party):
Jay Hoofnagle, M.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: May 1, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: S-adenosyl methionine for Chronic Liver Disease

  Participant Flow


  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.
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Reporting Groups
  Description
Hepatitis C Treated With Peginterferon and Ribavirin Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin

Baseline Measures
   Hepatitis C Treated With Peginterferon and Ribavirin 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Year]
Median (Full Range)
 52.5 
 (41 to 65) 
Gender 
[Units: Participants]
 
Female   8 
Male   16 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
Hispanic   1 
Black   2 
White   21 
[1] Race
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27.2  (3.74) 
Ishak Fibrosis [1] 
[Units: Units on a scale]
Median (Full Range)
 2 
 (0 to 6) 
[1] Possible range is 0 to 6. Higher values represent worse outcomes.
Cirrhosis 
[Units: Participants]
 
Cirrhosis   5 
Non-Cirrhosis   19 
Previous Therapy 
[Units: Participants]
 
Interferon/ribavirin   3 
Peginterferon/ribavirin   21 
Baseline HCV RNA Level 
[Units: Log10 (IU/mL)]
Mean (Standard Deviation)
 6.3  (0.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvement in Viral Kinetics During the First 2 Weeks of Therapy   [ Time Frame: Days 7 to 14 of therapy ]

2.  Secondary:   2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).   [ Time Frame: 12 weeks from start of therapy ]


  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
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  More Information