Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

Ainos

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: placebo lozenges; Drug: interferon-alpha lozenges

Study type: Interventional

Funder types: Industry

Identifiers

NCT00695019

07HWHC09

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 3 patient groups, including a placebo group

500 IU qd

Experimental group

Description:

500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day

Treatment:

Drug: interferon-alpha lozenges

500 IU tid

Experimental group

Description:

500 IU interferon-alpha lozenge taken 3 times per day

Treatment:

Drug: interferon-alpha lozenges

placebo

Placebo Comparator group

Description:

placebo lozenges taken 3 times per day

Treatment:

Drug: placebo lozenges