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CompletedNCT00695019Updated Feb 21, 2024Results posted

Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

A Phase 2 interventional study of interferon-alpha lozenges and placebo lozenges in Hepatitis C, Chronic, sponsored by Ainos, Inc. (f/k/a Amarillo Biosciences Inc.. Completed at 9 sites in Taiwan. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
169
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis C, Chronic

Keywords

  • Prevention of Relapse
  • HCV genotype 1b
  • Recurrence
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 169 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Ainos, Inc. (f/k/a Amarillo Biosciences Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
169 participants (actual)

Study arms

  • Experimental
    500 IU qd

    500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day

    Drug: interferon-alpha lozenges

  • Experimental
    500 IU tid

    500 IU interferon-alpha lozenge taken 3 times per day

    Drug: interferon-alpha lozenges

  • Placebo comparator
    placebo

    placebo lozenges taken 3 times per day

    Drug: placebo lozenges

Interventions

  • Druginterferon-alpha lozenges

    500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks

    Also known as: IFN-alpha, Veldona lozenges, oral interferon, IFN-alpha lozenges, oral interferon lozenges

  • Drugplacebo lozenges

    200 mg matching placebo lozenges

    Also known as: sugar pills

06

What researchers measure

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.

    Time frame: 48 weeks

Secondary outcomes

  1. Sustained Virologic Response Rate

    Percentage of participants who remained HCV RNA negative throughout the study

    Time frame: 48 weeks

  2. Normalization of ALT

    Percentage of participants with a normal serum ALT level at the end of the study

    Time frame: 48 weeks

  3. Change in Serum HCV RNA Concentration

    Change in serum HCV RNA concentration (log10 IU) from baseline to week 48

    Time frame: 48 weeks

  4. Change in Serum ALT

    Change in Serum ALT concentration from baseline to week 48

    Time frame: 48 weeks

  5. 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.

    Time frame: 48 weeks

  6. Change in Fibrotest Score

    Change in fibrotest score from baseline to week 48

    Time frame: 48 weeks

07

Results

Posted Oct 31, 2013

Participant flow

Subjects undergoing treatment for HCV infection at one of the 9 participating hospitals were approached, and those willing to sign informed consent were screened for eligibility.

Participant flow — Overall Study
Milestone500 IU qd500 IU TidPlacebo
Started595357
Completed463947
Not completed131410
Withdrew: Withdrawal by subject864
Withdrew: Protocol violation131
Withdrew: Lack of efficacy001
Withdrew: Various454

Outcome measures

SecondarySustained Virologic Response Rate

Percentage of participants who remained HCV RNA negative throughout the study

Time frame:
48 weeks
Reported as:
Number · percentage of participants
Sustained Virologic Response Rate
percentage of participants500 IU qd500 IU TidPlacebo
Sustained Virologic Response Rate71.262.366.7
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Chi-squared · p = 0.61
SecondaryNormalization of ALT

Percentage of participants with a normal serum ALT level at the end of the study

Time frame:
48 weeks
Reported as:
Number · percentage of participants
Normalization of ALT
percentage of participants500 IU qd500 IU TidPlacebo
Normalization of ALT71.260.464.9
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Chi-squared · p = 0.48
SecondaryChange in Serum HCV RNA Concentration

Change in serum HCV RNA concentration (log10 IU) from baseline to week 48

Time frame:
48 weeks
Reported as:
Log mean · log10 IU
Change in Serum HCV RNA Concentration
log10 IU500 IU qd500 IU TidPlacebo
Change in Serum HCV RNA Concentration1.6 ± 2.41.9 ± 2.51.7 ± 2.5
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Kruskal-Wallis · p = 0.77
SecondaryChange in Serum ALT

Change in Serum ALT concentration from baseline to week 48

Time frame:
48 weeks
Reported as:
Mean · U/L
Change in Serum ALT
U/L500 IU qd500 IU TidPlacebo
Change in Serum ALT7.8 ± 75.50.6 ± 36.68.6 ± 52.6
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Kruskal-Wallis · p = 0.30
PrimaryRelapse 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.

Time frame:
48 weeks
Reported as:
Number · percentage of participants
Relapse Rate
percentage of participants500 IU qd500 IU TidPlacebo
Relapse Rate30.537.735.1
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Chi-squared · p = 0.72
SecondaryChange 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.

Time frame:
48 weeks
Reported as:
Mean · change in score
Change in Social Functioning
change in score500 IU qd500 IU TidPlacebo
Change in Social Functioning21.6 ± 17.716.3 ± 20.98.8 ± 20.5
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Kruskal-Wallis · p = 0.0023 (Analysis not adjusted to account for baseline differences between the groups.)
SecondaryChange in Fibrotest Score

Change in fibrotest score from baseline to week 48

Time frame:
48 weeks
Reported as:
Mean · units on a scale
Change in Fibrotest Score
units on a scale500 IU qd500 IU TidPlacebo
Change in Fibrotest Score-0.37 ± 0.48-0.19 ± 0.46-0.31 ± 0.37
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Kruskal-Wallis · p = 0.21
Post-hocNormalization of Platelets

Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study

Time frame:
48 weeks
Reported as:
Number · percentage of participants
Normalization of Platelets
percentage of participants500 IU qd500 IU TidPlacebo
Normalization of Platelets81.050.041.9
Statistical analysis
  • 500 IU qd vs 500 IU Tid vs Placebo · Chi-squared · p = 0.03
  • 500 IU qd vs Placebo · Chi-squared · p = 0.005

Adverse events

Collected over 48 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
500 IU qd—2/59 (3.4%)52/59 (88.1%)
500 IU Tid—6/53 (11.3%)46/53 (86.8%)
Placebo—6/57 (10.5%)41/57 (71.9%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
Event500 IU qd500 IU TidPlacebo
Urinary Tract InfectionRenal and urinary disorders0/592/531/57
Esophageal ulcers with bleedingGastrointestinal disorders0/591/530/57
Cirrhotic liver noduleGastrointestinal disorders0/591/530/57
Worsening of benign prostate hyperplasiaRenal and urinary disorders0/591/530/57
InfluenzaRespiratory, thoracic and mediastinal disorders0/591/530/57
Gastric ulcers and anemiaGastrointestinal disorders0/590/531/57
right knee arthritis with synovitisNervous system disorders0/590/531/57
Right middle cerebral artery infarctionVascular disorders0/590/531/57
Thoracic aortic aneurysmCardiac disorders0/590/531/57
Dizziness with associated nausea and vomitingNervous system disorders0/590/531/57
Most frequent other events
Showing 10 of 23
Most frequent other events
Event500 IU qd500 IU TidPlacebo
Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders7/5910/534/57
PruritusSkin and subcutaneous tissue disorders9/596/537/57
InsomniaNervous system disorders6/596/536/57
HeadacheNervous system disorders5/594/536/57
Abdominal Pain UpperGastrointestinal disorders4/592/535/57
CoughRespiratory, thoracic and mediastinal disorders5/594/532/57
Irritable Bowel SyndromeGastrointestinal disorders3/590/534/57
MalaiseGeneral disorders1/592/534/57
Abdominal DistensionGastrointestinal disorders4/591/532/57
ConstipationGastrointestinal disorders4/591/533/57

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)500 IU qd500 IU TidPlaceboTotal
<=18 years0000
Between 18 and 65 years474447138
>=65 years1291031
Age, Continuous
Age, Continuous(years)500 IU qd500 IU TidPlaceboTotal
Mean54.9 ± 11.955.7 ± 10.856.8 ± 9.555.8 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)500 IU qd500 IU TidPlaceboTotal
Female27262578
Male32273291
Region of Enrollment
Region of Enrollment(participants)500 IU qd500 IU TidPlaceboTotal
Taiwan595357169
08

Study locations

9 sites
  • 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
  • Taipei Veterans General Hospital
    Taipei City, Taiwan
  • Chang Gung Memorial Hospital
    Taipei, 105, Taiwan
09

References and documents

Publications

  • 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. PubMed 24237300 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00695019
Lead sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborators
CytoPharm, Inc.
Responsible party
Sponsor
First posted
Jun 11, 2008
Start date
Jun 2009
Primary completion
Nov 2011
Completion
Feb 2012
Results posted
Oct 31, 2013
Last update
Feb 21, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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