Yallaferon in Chinese Population

HPV Infection Clinical Trial

Official title:

a Multi-sites, Randomized, Parallel, Placebo-Controlled Clinical, Pilot Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02593968
• Other study ID #: Zhaoke-1504-Yallaferon
• Status: Recruiting
• Phase: Phase 2
• First received: October 30, 2015
• Last updated: October 30, 2015
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: Lee's Pharmaceutical Limited
• Contact: Jian Zhao, MD
• Phone: +861066119025
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 25 to 65 years of age the sex life of female patients;

• High-risk HPV 16 and/or 18 positive

• Agree to sign ICF

Exclusion Criteria:

• Cervical intraepithelial neoplasia (CIN);

• Combined with a severe fungal, trichomonas vaginitis;

• Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;

• Allergies or allergy to the drug known ingredients.

• Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;

• Pregnant and lactating women and to be pregnant 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

• HPV Infection

Intervention

Drug:
• Recombinant Human Interferon a-2b Gel

• Placebo

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

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	HPV-16 and/or HPV-18 negative conversion rate	hr-HPV DNA negative conversion rate will be evaluated at 3 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression	3 months	No
Secondary	HPV-16 and/or HPV-18 negative conversion rate	hr-HPV DNA negative conversion rate will be evaluated at 6 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression	6 months	No
Secondary	HPV-16 and/or HPV-18 negative conversion rate	hr-HPV DNA negative conversion rate will be evaluated at 9 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression	9 months	No
Secondary	HPV-16 and/or HPV-18 negative conversion rate	hr-HPV DNA negative conversion rate will be evaluated at 12 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression	12 months	No
Secondary	reinfection at 12 months		12 months	No