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

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824992
• Other study ID #: LeesPharm_RHI
• Secondary ID: China State FDA
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 26, 2013
• Last updated: April 4, 2013
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HPV Infection
• Infection

Intervention

Drug:
• Yallaferon®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No