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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-four patients were enrolled at National Institutes of Health Clinic Center between October 2007 and April 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hepatitis C Treated With Peginterferon and Ribavirin Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.

Participant Flow:   Overall Study
    Hepatitis C Treated With Peginterferon and Ribavirin
STARTED   24 
COMPLETED   20 
NOT COMPLETED   4 
Adverse Event                2 
Withdrawal by Subject                1 
Protocol Violation                1 



  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
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
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1.  Primary:   Improvement in Viral Kinetics During the First 2 Weeks of Therapy   [ Time Frame: Days 7 to 14 of therapy ]
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Measure Type Primary
Measure Title Improvement in Viral Kinetics During the First 2 Weeks of Therapy
Measure Description Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy
Time Frame Days 7 to 14 of therapy  

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.
Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.

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

Measured Values
   Hepatitis C Treated With Peginterferon and Ribavirin 
Participants Analyzed 
[Units: Participants]
 20 
Improvement in Viral Kinetics During the First 2 Weeks of Therapy 
[Units: Participants]
 14 

No statistical analysis provided for Improvement in Viral Kinetics During the First 2 Weeks 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
No text entered.


  More Information