NCT01824992

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HPV Infection

Interventions

Type	Name	Description
DRUG	Yallaferon®

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-03-01
• Completion: 2012-09-01
• First posted: 2013-04-05
• Last updated: 2013-04-05