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Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers

NCT00882193 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-11-30

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Hepatitis C
  • Genotype 1
  • Relapse

Interventions

DRUG

Betaine

Betaine 20 gm/day in 2 divided doses for 48 weeks

DRUG

Peginterferon alpha 2a

Peginterferon alpha 2a 180mcg/0.5ml by subcutaneous injection weekly for 48 weeks

DRUG

Ribavirin

Ribavirin 200mg - weight based, 1000 - 1200 mg/day for body weight \< or \> 75mg in 2 divided doses

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Mark E Mailliard, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-01
Primary Completion
2011-01-12
Completion
2011-01-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882193 on ClinicalTrials.gov