Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical HPV-16 and / or HPV-18 Infection

Intervention / Treatment
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* Drug: Yallaferon®， the recombinant human interferon α-2b gel
* Other: gel without active ingredient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; History of suffering CNS diseases, epilepsy and/or psychological disorder; Pregnant and lactating 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 |
| --- | --- |
| Active Comparator: Treatment group<br>received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment | Drug: Yallaferon®， the recombinant human interferon α-2b gel<br> <br> |
| Placebo Comparator: controlled group<br>received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment | Other: gel without active ingredient<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 |  | 1 year |