Clinical Trials Logo
  1. Home
  2. Chronic Hepatitis C
  3. NCT00882193

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

Chronic Hepatitis C Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00882193
Study type Interventional
Source University of Nebraska
Contact
Status Terminated
Phase Early Phase 1
Start date May 1, 2009
Completion date January 12, 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03673696 - The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects Phase 1
Completed NCT02250001 - Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C N/A
Completed NCT03088917 - 'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT02865369 - Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment N/A
Recruiting NCT02638233 - Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy Phase 4
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Completed NCT02788682 - Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy N/A
Not yet recruiting NCT01949168 - A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV Phase 2
Completed NCT01439776 - Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients Phase 4
Recruiting NCT01360892 - Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography N/A
Recruiting NCT01360879 - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease N/A
Terminated NCT00962936 - Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection Phase 1/Phase 2
Completed NCT00968357 - Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed Phase 2
Recruiting NCT01178749 - Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments N/A
Recruiting NCT00575627 - Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels Phase 4
Completed NCT00537407 - A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment Phase 2
Recruiting NCT00370617 - Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance Phase 4
Completed NCT01684787 - Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients Phase 4