Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amarillo Biosciences, Inc.
• Collaborator: CytoPharm, Inc.
• Treatments: Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• HCV genotype 1b

• Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks

• Serum HCV RNA negative within 4 weeks of study entry

Exclusion Criteria:

• Child-Pugh score of B or C

• Decompensated liver function

• History of malignancy within past 5 years

• Other causes of liver disease besides HCV infection

• Uncontrolled diabetes or hypertension

• Unwilling to use two forms of birth control during study treatment