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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jay Hoofnagle, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00475176
First received: May 17, 2007
Last updated: May 31, 2013
Last verified: May 2013
Results First Received: May 1, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  27.2  ± 3.74  
Ishak Fibrosis [2]
[units: Units on a scale]
Median ( Full Range )
  2  
  ( 0 to 6 )  
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  
[1] Race
[2] Possible range is 0 to 6. Higher values represent worse outcomes.



  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 ]

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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jay H. Hoofnagle, M.D.
Organization: National Institute of Diabetes and Digestive and Kidney Diseases, National In
phone: 301-496-1333
e-mail: hoofnaglej@mail.nih.gov


Publications:
Publications automatically indexed to this study:

Responsible Party: Jay Hoofnagle, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00475176     History of Changes
Other Study ID Numbers: 070143, 07-DK-0143, 07-DK-0143
Study First Received: May 17, 2007
Results First Received: May 1, 2012
Last Updated: May 31, 2013
Health Authority: United States: Federal Government