Yallaferon in Chinese Population

Phase 2UnknownNCT02593968

Lee's Pharmaceutical Limited100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

HPV Infection

Interventions

Recombinant Human Interferon a-2b GelDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University First Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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

Time frame: 6 months

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

Time frame: 9 months

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

Time frame: 12 months

reinfection at 12 months

Time frame: 12 months

Central Contacts

Jian Zhao, MD

CONTACT

+861066119025

Data from ClinicalTrials.gov

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