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

Phase 2

Completed

• Conditions: HPV Infection
• Interventions: Drug: Yallaferon®

• Registration Number: NCT01824992
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-03
• Study Completion: 2012-09
• Study First Submitted: 2013-03-26
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-04
• Last Update Submitted: 2013-04-04
• Study First Posted: 2013-04-05
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 325

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug	Yallaferon®	subject were treated with Yallaferon®， the recombinant human interferon α-2b gel

Primary Outcome Measures

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

Secondary Outcome Measures

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