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

Lee's Pharmaceutical

Status and phase: Unknown; Phase 3; Phase 2

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

Treatments: Drug: Yallaferon®， the recombinant human interferon α-2b gel; Other: gel without active ingredient

Study type: Interventional

Funder types: Industry

Identifiers

NCT02801383

Zhaoke-201509-RHI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment

Treatment:

Drug: Yallaferon®， the recombinant human interferon α-2b gel

controlled group

Placebo Comparator group

Description:

received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment

Treatment:

Other: gel without active ingredient