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

Phase 2

• Conditions: Cervical HPV-16 and / or HPV-18 Infection
• Interventions: Other: gel without active ingredient; Drug: Yallaferon®， the recombinant human interferon α-2b gel

• Registration Number: NCT02801383
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief 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.

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 Timeline

• Study Start: 2015-09
• Status Verified: 2016-06
• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-14
• Last Update Submitted: 2016-06-14
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled group	gel without active ingredient	received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment
Treatment group	Yallaferon®， the recombinant human interferon α-2b gel	received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment

Primary Outcome Measures

Name	Time	Method
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate	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.

Secondary Outcome Measures

Name	Time	Method
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate	six months, nine months and twelve months	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.
The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups	1 year

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Peking, China