Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-Responder/Relapsers
| Status: | Archived |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2009 |
Pilot Therapy Using Betaine in Combination With Peginterferon Alpha-2a Plus Ribavirin in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Pegylated Interferon and Ribavirin
This is a non-randomized, open-label study examining the safety and efficacy of betaine in
addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or
relapsers to previous pegylated interferon plus ribavirin. Betaine (20 gm/day) in 2 divided
doses will be added to Peginterferon alpha 2a (180 mcg) plus weight-based Ribavirin (1000 or
1200 mg/day, for body weight < or > 75 kg, respectively, for 48 weeks. Patients must be
diagnosed with chronic hepatitis C, genotype I, and have undergone therapy for hepatitis C
with pegylated interferon plus ribavirin. Subjects will be followed for safety,
tolerability, hepatitis C viral response and the effect on interferon gene signaling in
peripheral blood mononuclear cells during therapy.
The primary objective is to examine the safety and efficacy of the betaine when combined
with standard anti-viral therapy in previously treated adult subjects with chronic hepatitis
C infected with genotype 1. The efficacy will be determined through comparison of the
sustained viral response (SVR) to our protocol three-drug regimen (Betaine, Peginterferon
plus Ribavirin) to that historically seen in relapsers and non-responders when retreated
with standard therapy (Peginterferon and Ribavirin alone).
Secondary objectives include: (1) the comparison of the occurrence of rapid and early
virologic response in the first 4 (Rapid Virologic Response, RVR) and 12 (Early Virologic
Response, EVR) weeks of therapy, respectively, between the study regimen and historically
treated patients. (2) the comparison of ALT normalization between the two groups. and (3)
the effect on interferon gene signaling in peripheral blood mononuclear cells (PBMCs)
between the two groups in the first 12 weeks of therapy and 6 months following the end of
therapy..
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