NCT02801383

Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections

Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: Female
• Age: 25 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 HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.

Detailed description

100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment, whereas no treatment was conducted in control group.

Conditions

• Cervical HPV-16 and / or HPV-18 Infection

Interventions

Type	Name	Description
DRUG	Yallaferon®， the recombinant human interferon α-2b gel
OTHER	gel without active ingredient

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-06-15
• Last updated: 2016-06-15

Locations

1 site across 1 country: China