Recombinant Human Interferon a-2b Gel for HPV 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 high-risk HPV infections; to analyze the HPV type infections and clinical negative conversion. 285 patients with positive high risk HPV infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.

Official Title
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a Multi-sites, Randomized, Parallel, Controlled Clinical 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: Yallaferon®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30 to 65 years of age the sex life of female patients; , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells; , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive). 15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68 Exclusion Criteria: (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.

Ages Eligible for Study
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Minimum Age: 30 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>subject only got observation | |
| Experimental: Drug<br>subject were treated with Yallaferon®， the recombinant human interferon α-2b gel | Drug: Yallaferon®<br> <br> * Other names: Yallaferon®， the recombinant human interferon α-2b gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of hr-HPV DNA negative conversion rate | Primary efficacy endpoint was the difference of hr-HPV DNA negative conversion rate on the 6th month between the two groups. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups. | Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups. Evaluation criteria: Negative conversion was defined as all positive hr-HPV DNA at baseline turning negative. Non-negative conversion was defined as at least one of the positive hr-HPV DNA at baseline not turning negative. | six months |