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

Cervical HPV-16 and / or HPV-18 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801383
• Other study ID #: Zhaoke-201509-RHI
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 12, 2016
• Last updated: June 14, 2016
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: June 2016
• Source: Lee's Pharmaceutical Limited
• Contact: Jian Zhao
• Phone: 010-83572075
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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 ? / ?, 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Other:
• gel without active ingredient

Locations

Country	Name	City	State
China	Peking University First Hospital	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups		1 year	No