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


  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
  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


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


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
No text entered.  


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