Phase 2
Completed N=169
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00695019 ↗
Enrolled (actual)
169
Serious AEs
8.3%
Results posted
Oct 2013
Primary outcomePrimary: Relapse Rate — 30.5; 37.7; 35.1 percentage of participants — p=0.72
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse Rate |
30.5; 37.7; 35.1 | 0.72 |
| SECONDARY Sustained Virologic Response Rate |
71.2; 62.3; 66.7 | 0.61 |
| SECONDARY Normalization of ALT |
71.2; 60.4; 64.9 | 0.48 |
| SECONDARY Change in Serum HCV RNA Concentration |
1.6; 1.9; 1.7 | 0.77 |
| SECONDARY Change in Serum ALT |
7.8; 0.6; 8.6 | 0.30 |
| SECONDARY Change in Social Functioning |
21.6; 16.3; 8.8 | 0.0023 sig |
| SECONDARY Change in Fibrotest Score |
-0.37; -0.19; -0.31 | 0.21 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00695019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.