Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
interferon-alpha lozenges · 1 trial · 1 indication
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 * ...
Interferon-alpha lozenges are used for chronic hepatitis C. They are being developed as a treatment to prevent relapse in patients with this condition. The drug is administered orally in lozenge form and is currently in clinical development.
Interferon-alpha lozenges are being developed by Ainos, Inc., a company traded on the NASDAQ under the ticker symbol AIMD. The company is conducting clinical research on this drug for chronic hepatitis C.
Interferon-alpha lozenges are in Phase 2 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied for its potential to prevent relapse in patients with chronic hepatitis C.
Interferon-alpha lozenges have been studied in one completed Phase 2 clinical trial, identified as NCT00695019. This trial was titled "Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C" and enrolled 169 participants in Taiwan.
Interferon-alpha lozenges are a specific oral formulation of interferon-alpha, designed to be taken as a lozenge. This formulation is being developed by Ainos, Inc. for chronic hepatitis C, distinguishing it from other forms of interferon-alpha.