Effect of High Dose vs. Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3, High Viral Load Without Rapid Virological Response (DARGEN-3)

NCT00830609 Phase 4 COMPLETED

The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.

Details

Lead sponsor	Dr. Conrado Fernandez
Phase	Phase 4
Status	COMPLETED
Enrolment	101
Start date	2008-11
Completion	2011-12

Conditions

• Chronic Hepatitis C

Interventions

• Peginterferon alfa 2 A
• Peginterferon alfa 2 A, ribavirin + Epo Beta
• ribavirin
• ribavirin
• Peginterferon alfa 2
• ribavirin

Primary outcomes

• Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment. — 1 year

Countries

Spain