Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00695019 | Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C | PHASE2 | COMPLETED | 169 | — | — | Jun 1, 2009 | Feb 1, 2012 | Feb 21, 2024 | 9 | Taiwan |
Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml.
| Arm | Type | Description |
|---|---|---|
| 500 IU qd | EXPERIMENTAL | 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day |
| 500 IU tid | EXPERIMENTAL | 500 IU interferon-alpha lozenge taken 3 times per day |
| placebo | PLACEBO_COMPARATOR | placebo lozenges taken 3 times per day |
| Name | Type | Description |
|---|---|---|
| interferon-alpha lozenges | DRUG | 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks |
| placebo lozenges | DRUG | 200 mg matching placebo lozenges |
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 * ...