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Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
interferon-alpha lozenges
placebo lozenges
Sponsored by
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Prevention of Relapse, HCV genotype 1b, Recurrence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dalin Buddhist Tzu Chi General Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Show-Chwan Memorial Hospital
  • Chia-Yi Chang Gung Memorial Hospital
  • Chiayi Christian Hospital
  • Keelung Chang Gung Memorial Hospital
  • China Medical University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

500 IU qd

500 IU tid

placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sustained Virologic Response Rate
Percentage of participants who remained HCV RNA negative throughout the study
Normalization of ALT
Percentage of participants with a normal serum ALT level at the end of the study
Change in Serum HCV RNA Concentration
Change in serum HCV RNA concentration (log10 IU) from baseline to week 48
Change in Serum ALT
Change in Serum ALT concentration from baseline to week 48
Change in Social Functioning
Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48 Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities.
Change in Fibrotest Score
Change in fibrotest score from baseline to week 48

Full Information

First Posted
June 9, 2008
Last Updated
August 27, 2013
Sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborators
CytoPharm, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00695019
Brief Title
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Low-Dose Human Interferon-alpha by the Oral Mucosal Route During the 6-Month Follow-up Period of Standard Combination Therapy for Hepatitis C Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborators
CytoPharm, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Prevention of Relapse, HCV genotype 1b, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
500 IU qd
Arm Type
Experimental
Arm Description
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
Arm Title
500 IU tid
Arm Type
Experimental
Arm Description
500 IU interferon-alpha lozenge taken 3 times per day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo lozenges taken 3 times per day
Intervention Type
Drug
Intervention Name(s)
interferon-alpha lozenges
Other Intervention Name(s)
IFN-alpha, Veldona lozenges, oral interferon, IFN-alpha lozenges, oral interferon lozenges
Intervention Description
500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
placebo lozenges
Other Intervention Name(s)
sugar pills
Intervention Description
200 mg matching placebo lozenges
Primary Outcome Measure Information:
Title
Relapse Rate
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Sustained Virologic Response Rate
Description
Percentage of participants who remained HCV RNA negative throughout the study
Time Frame
48 weeks
Title
Normalization of ALT
Description
Percentage of participants with a normal serum ALT level at the end of the study
Time Frame
48 weeks
Title
Change in Serum HCV RNA Concentration
Description
Change in serum HCV RNA concentration (log10 IU) from baseline to week 48
Time Frame
48 weeks
Title
Change in Serum ALT
Description
Change in Serum ALT concentration from baseline to week 48
Time Frame
48 weeks
Title
Change in Social Functioning
Description
Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48 Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities.
Time Frame
48 weeks
Title
Change in Fibrotest Score
Description
Change in fibrotest score from baseline to week 48
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dalin Buddhist Tzu Chi General Hospital
City
Dalin
State/Province
Chiayi County
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Niaosong
State/Province
Kaosiung County
Country
Taiwan
Facility Name
Show-Chwan Memorial Hospital
City
Changhua
Country
Taiwan
Facility Name
Chia-Yi Chang Gung Memorial Hospital
City
Chia-Yi
Country
Taiwan
Facility Name
Chiayi Christian Hospital
City
Chiayi
Country
Taiwan
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
105
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24237300
Citation
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.
Results Reference
derived

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Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

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