Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Low-Dose Human Interferon-alpha During the 6-Month Follow-up Period of Standard Combination Therapy for Hepatitis C Virus Infection
1 other identifier
interventional
169
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
October 31, 2013
CompletedFebruary 21, 2024
August 1, 2013
2.4 years
June 9, 2008
February 5, 2013
January 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse Rate
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.
48 weeks
Secondary Outcomes (6)
Sustained Virologic Response Rate
48 weeks
Normalization of ALT
48 weeks
Change in Serum HCV RNA Concentration
48 weeks
Change in Serum ALT
48 weeks
Change in Social Functioning
48 weeks
- +1 more secondary outcomes
Study Arms (3)
500 IU qd
EXPERIMENTAL500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
500 IU tid
EXPERIMENTAL500 IU interferon-alpha lozenge taken 3 times per day
placebo
PLACEBO COMPARATORplacebo lozenges taken 3 times per day
Interventions
500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.lead
- CytoPharm, Inc.collaborator
Study Sites (9)
Dalin Buddhist Tzu Chi General Hospital
Dalin, Chiayi County, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Niaosong, Kaosiung County, Taiwan
Show-Chwan Memorial Hospital
Changhua, Taiwan
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan
Chiayi Christian Hospital
Chiayi City, Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chang Gung Memorial Hospital
Taipei, 105, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Related Publications (1)
Lee CM, Chen CY, Chien RN, Tseng KC, Peng CY, Tung SY, Fang YJ, Huang YH, Lu SN, Hung CH, Tsai TJ, Fang CC, Hsu CW, Yeh CT. A double-blind randomized controlled study to evaluate the efficacy of low-dose oral interferon-alpha in preventing hepatitis C relapse. J Interferon Cytokine Res. 2014 Mar;34(3):187-94. doi: 10.1089/jir.2013.0074. Epub 2013 Nov 15.
PMID: 24237300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Martin J. Cummins, Director of Clinical & Regulatory Affairs
- Organization
- Amarillo Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 11, 2008
Study Start
June 1, 2009
Primary Completion
November 1, 2011
Study Completion
February 1, 2012
Last Updated
February 21, 2024
Results First Posted
October 31, 2013
Record last verified: 2013-08