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

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ClinicalTrials.gov Identifier: NCT00475176
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : July 5, 2013
Last Update Posted : July 5, 2013
Sponsor:
Information provided by (Responsible Party):

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

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
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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. 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


  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

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