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

Lee's Pharmaceutical

Status and phase

Completed

Phase 3

Phase 2

Conditions

HPV Infection

Treatments

Drug: Yallaferon®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01824992

LeesPharm_RHI

China State FDA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

325 patients

Sex

Female

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

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.