HPV InfectionPhase 2NCT02593968
Yallaferon in Chinese Population
A Phase 2 study testing Recombinant Human Interferon a-2b Gel in people with HPV Infection, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- Recombinant Human Interferon a-2b Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25 to 65 years of age the sex life of female patients;
- High-risk HPV 16 and/or 18 positive
- Agree to sign ICF
Who cannot join
- Cervical intraepithelial neoplasia (CIN);
- Combined with a severe fungal, trichomonas vaginitis;
- Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;
- Allergies or allergy to the drug known ingredients.
- Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;
- Pregnant and lactating women and to be pregnant women;
- The researchers do not consider it appropriate clinical trials.
Trial locations and contacts
1 site in 1 country.
Jian Zhao, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Jian Zhao, MD, +86-10-66119025
About this study
Official title: a Multi-sites, Randomized, Parallel, Placebo-Controlled Clinical, Pilot Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection
The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.
- Conditions
- HPV Infection
- Being tested
- Recombinant Human Interferon a-2b Gel, Placebo
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Interferon a-2b GelDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | subject were treated 3 periods with Yallaferon®; each period has interval 10 days ; one period included Yallaferon application for every other day for 10 times Receives: Drug: Recombinant Human Interferon a-2b Gel |
| Plcaebo | Placebo comparator | subject were treated 3 periods with Yallaferon® Plcaebo; each period has interval 10 days; one period included Yallaferon application for every other day for 10 times Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 3 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Measured: 3 months
Secondary outcomes (4)
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 6 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Measured: 6 months
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 9 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Measured: 9 months
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 12 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Measured: 12 months
reinfection at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593968
- Sponsor's protocol ID
- Zhaoke-1504-Yallaferon
- Status last verified
- Oct 2015
- First submitted
- 30 Oct 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Multi-sites, Randomized, Parallel, Placebo-Controlled Clinical, Pilot Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection
- ClinicalTrials.gov ID
- NCT02593968
- Acronym / sponsor ID
- Zhaoke-1504-Yallaferon
- Conditions
- HPV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
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 evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Recombinant Human Interferon a-2b Gelsubject were treated 3 periods with Yallaferon®; each period has interval 10 days ; one period included Yallaferon application for every other day for 10 times |
| Plcaebo | Placebo comparator | Drug: Placebosubject were treated 3 periods with Yallaferon® Plcaebo; each period has interval 10 days; one period included Yallaferon application for every other day for 10 times |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 25 to 65 years of age the sex life of female patients;
- High-risk HPV 16 and/or 18 positive
- Agree to sign ICF
Key exclusion criteria (7 listed)
- Cervical intraepithelial neoplasia (CIN);
- Combined with a severe fungal, trichomonas vaginitis;
- Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;
- Allergies or allergy to the drug known ingredients.
- Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;
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 |
|---|---|---|
| Recombinant Human Interferon a-2b Gel | Drug | Treatment |
| Placebo | Drug | Plcaebo |
Primary outcome
HPV-16 and/or HPV-18 negative conversion rate
Time frame: 3 months
hr-HPV DNA negative conversion rate will be evaluated at 3 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
4 secondary outcomes
HPV-16 and/or HPV-18 negative conversion rate
Time frame: 6 months
HPV-16 and/or HPV-18 negative conversion rate
Time frame: 9 months
HPV-16 and/or HPV-18 negative conversion rate
Time frame: 12 months
reinfection at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
Jian Zhao, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Interferon a-2b Gel in people with HPV Infection, run by Lee's Pharmaceutical Limited at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhao, MD (+861066119025), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV-16 and/or HPV-18 negative conversion rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2015.