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

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

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 Overview

• Status: Completed
• Conditions: HPV Infection
• Intervention / Treatment: Drug: Yallaferon®

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation; subject only got observation
Experimental: Drug; subject were treated with Yallaferon®， the recombinant human interferon α-2b gel	Drug: Yallaferon®; Other Names: Yallaferon®， the recombinant human interferon α-2b gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Estimate): April 5, 2013
• Last Update Submitted That Met QC Criteria: April 4, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Infections; Communicable Diseases; Papillomavirus Infections; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons
• Other Study ID Numbers: LeesPharm_RHI; China State FDA (Other Identifier: China State Food and Drug Administration)