Cervical HPV-16 and / or HPV-18 InfectionPhase 2/3NCT02801383
Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections
A Phase 2/3 study testing Yallaferon®， the recombinant human interferon α-2b gel and gel without active ingredient in people with Cervical HPV-16 and / or HPV-18 Infection, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Cervical HPV-16 and / or HPV-18 Infection
- What is being tested?
- Yallaferon®， the recombinant human interferon α-2b gel and gel without active ingredient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Mar 2017
- Phase
- Phase 2/3
- 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 with the sex life of female patients;
- HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.
Who cannot join
- Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer;
- Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients;
- Associated with acute, severe bacterial or viral infection;
- Autoimmune diseases;
- Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs;
- Allergies or allergy to the drug known ingredients;
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- History of suffering CNS diseases, epilepsy and/or psychological disorder;
- Pregnant and lactating women;
- The researchers do not consider it appropriate clinical trials.
Trial locations and contacts
1 site in 1 country.
Jian Zhao contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Jian Zhao, M.D., 010-83572075
About this study
Official title: Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection
to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.
Read the detailed description
100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment, whereas no treatment was conducted in control group.
- Being tested
- Yallaferon®， the recombinant human interferon α-2b gel, gel without active ingredient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yallaferon®， the recombinant human interferon α-2b gelDrug
gel without active ingredientOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment Receives: Drug: Yallaferon®， the recombinant human interferon α-2b gel |
| controlled group | Placebo comparator | received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment Receives: Other: gel without active ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Primary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 3th month between the two groups.
Measured: three months
Secondary outcomes (2)
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Secondary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 6th, 9th and 12th month between the two groups.
Measured: six months, nine months and twelve months
The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical HPV-16 and / or HPV-18 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 2/3
- 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
- NCT02801383
- Sponsor's protocol ID
- Zhaoke-201509-RHI
- Status last verified
- Jun 2016
- First submitted
- 12 Jun 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection
- ClinicalTrials.gov ID
- NCT02801383
- Acronym / sponsor ID
- Zhaoke-201509-RHI
- Phase
- Phase 2/3
- 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
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 15 Jun 2016 (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.
to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.
Detailed description
100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment, whereas no treatment was conducted in control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: Yallaferon®， the recombinant human interferon α-2b gelreceived 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment |
| controlled group | Placebo comparator | Other: gel without active ingredientreceived 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 25 to 65 years of age with the sex life of female patients;
- HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.
Key exclusion criteria (9 listed)
- Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer;
- Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients;
- Associated with acute, severe bacterial or viral infection;
- Autoimmune diseases;
- Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs;
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 |
|---|---|---|
| Yallaferon®， the recombinant human interferon α-2b gel | Drug | Treatment group |
| gel without active ingredient | Other | controlled group |
Primary outcome
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Time frame: three months
Primary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 3th month between the two groups.
2 secondary outcomes
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Time frame: six months, nine months and twelve months
The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
Related trials for Cervical HPV-16 and / or HPV-18 Infection
Not yet recruitingPhase 1/2
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3
Human Papillomavirus Associated Intraepithelial Neoplasia, Cervical Intraepithelial Neoplasia Grade 2/3
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 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Yallaferon®， the recombinant human interferon α-2b gel and gel without active ingredient in people with Cervical HPV-16 and / or HPV-18 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 2 inclusion and 9 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 15 Jun 2016. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (010-83572075), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate (time frame: three 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 15 Jun 2016.