Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections

Lee's Pharmaceutical Limited325 enrolled

Overview

to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type infections and clinical negative conversion. 285 patients with positive high risk HPV infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

325

Conditions

HPV Infection

Interventions

Yallaferon®

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 30 to 65 years of age the sex life of female patients; 2. , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells; 3. , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive). 15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68 Exclusion Criteria: * (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.

Outcomes

Primary Outcomes

difference of hr-HPV DNA negative conversion rate

Primary efficacy endpoint was the difference of hr-HPV DNA negative conversion rate on the 6th month between the two groups.

Time frame: six months

Secondary Outcomes

Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups.

Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups. Evaluation criteria: Negative conversion was defined as all positive hr-HPV DNA at baseline turning negative. Non-negative conversion was defined as at least one of the positive hr-HPV DNA at baseline not turning negative.

Time frame: six months