Yallaferon in Chinese Population

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.

Official Title
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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

Conditions
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HPV Infection

Intervention / Treatment
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* Drug: Recombinant Human Interferon a-2b Gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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 | Drug: Recombinant Human Interferon a-2b Gel<br> <br> |
| Placebo Comparator: Plcaebo<br>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 | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 12 months | 
| reinfection at 12 months |  | 12 months |