Hepatitis C, ChronicPhase 2NCT00695019
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
A Phase 2 study testing interferon-alpha lozenges in people with Hepatitis C, Chronic, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 9 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- interferon-alpha lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 9 sitesTaiwan
- Study dates
- Jun 2009to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Show-Chwan Memorial Hospital
Changhua
Chiayi Chang Gung Memorial Hospital
Chiayi City
Chiayi Christian Hospital
Chiayi City
Dalin Buddhist Tzu Chi General Hospital
Dalin, Chiayi County
Keelung Chang Gung Memorial Hospital
Keelung
Kaohsiung Chang Gung Memorial Hospital
Niaosong, Kaosiung County
China Medical University Hospital
Taichung
Chang Gung Memorial Hospital
Taipei, 105
Taipei Veterans General Hospital
Taipei
About this study
Official title: 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
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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- interferon-alpha lozenges, placebo lozenges
- Keywords
- Prevention of Relapse, HCV genotype 1b, Recurrence
- Medical subject headings
- Hepatitis C, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon-alpha lozengesDrug
Also called IFN-alpha, Veldona lozenges, oral interferon, IFN-alpha lozenges
500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
placebo lozengesDrug
Also called sugar pills
200 mg matching placebo lozenges
| Study group | Role | What they receive |
|---|---|---|
| 500 IU qd | Experimental | 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day Receives: Drug: interferon-alpha lozenges |
| 500 IU tid | Experimental | 500 IU interferon-alpha lozenge taken 3 times per day Receives: Drug: interferon-alpha lozenges |
| placebo | Placebo comparator | placebo lozenges taken 3 times per day Receives: Drug: placebo lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (6)
Sustained Virologic Response Rate
Percentage of participants who remained HCV RNA negative throughout the study
Measured: 48 weeks
Normalization of ALT
Percentage of participants with a normal serum ALT level at the end of the study
Measured: 48 weeks
Change in Serum HCV RNA Concentration
Change in serum HCV RNA concentration (log10 IU) from baseline to week 48
Measured: 48 weeks
Change in Serum ALT
Change in Serum ALT concentration from baseline to week 48
Measured: 48 weeks
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.
Measured: 48 weeks
Change in Fibrotest Score
Change in fibrotest score from baseline to week 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJun 2009
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CytoPharm, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695019
- Sponsor's protocol ID
- 07HWHC09
- Status last verified
- Aug 2013
- First submitted
- 9 Jun 2008
- Last updated
- 21 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00695019
- Acronym / sponsor ID
- 07HWHC09
- Conditions
- Hepatitis C, Chronic
- Keywords
- Prevention of Relapse, HCV genotype 1b, Recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- CytoPharm, Inc.
- Study start
- Jun 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Posted 31 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 500 IU qd | Experimental | Drug: interferon-alpha lozenges500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day |
| 500 IU tid | Experimental | Drug: interferon-alpha lozenges500 IU interferon-alpha lozenge taken 3 times per day |
| placebo | Placebo comparator | Drug: placebo lozengesplacebo lozenges taken 3 times per day |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon-alpha lozengesAlso: IFN-alpha, Veldona lozenges, oral interferon, IFN-alpha lozenges500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks | Drug | 500 IU qd, 500 IU tid |
| placebo lozengesAlso: sugar pills200 mg matching placebo lozenges | Drug | placebo |
Primary outcome
Relapse Rate
Time frame: 48 weeks
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.
6 secondary outcomes
Sustained Virologic Response Rate
Time frame: 48 weeks
Normalization of ALT
Time frame: 48 weeks
Change in Serum HCV RNA Concentration
Time frame: 48 weeks
Change in Serum ALT
Time frame: 48 weeks
Change in Social Functioning
Time frame: 48 weeks
Change in Fibrotest Score
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24237300Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interferon-alpha lozenges in people with Hepatitis C, Chronic, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 9 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Rate (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00695019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.