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

NCT01824992 | Completed Phase 2

• 2 other identifiers: LeesPharm_RHIChina State FDA
• Study Type: interventional
• Target: 325
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Observation

NO INTERVENTION

subject only got observation

Drug

EXPERIMENTAL

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

Drug: Yallaferon®

Interventions

Yallaferon® DRUG

Also known as: Yallaferon®， the recombinant human interferon α-2b gel

Drug

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 to 65 years of age the sex life of female patients;
• , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells;
• , 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).
• kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68

You may not qualify if:

• (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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 5, 2013
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 5, 2013

Record last verified: 2013-04