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
Sponsor study identifier
interventional
169
1 country
9
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Actual (reported)Study Completion
February 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 9, 2008
Actual (reported)June 11, 2008
Actual (reported)June 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 2011
Actual (reported)February 2012
Actual (reported)October 31, 2013
Actual (reported)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
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
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
500 IU interferon-alpha lozenge taken 3 times per day
placebo lozenges taken 3 times per day
500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
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
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.
169 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2008
First Posted
June 11, 2008
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
200 mg matching placebo lozenges
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Chang Gung Memorial Hospital
Taipei, 105, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Primary Completion
November 2011
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
February 21, 2024
Results First Posted
October 31, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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