HPV Infection
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.
Interventions
DRUGRecombinant Human Interferon a-2b Gel
DRUGPlacebo
Sponsors
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 25 to 65 years of age the sex life of female patients; * High-risk HPV 16 and/or 18 positive * Agree to sign ICF
Exclusion criteria
* Cervical intraepithelial neoplasia (CIN); * Combined with a severe fungal, trichomonas vaginitis; * Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; * Allergies or allergy to the drug known ingredients. * Within 30 days to accept other clinical trials of drugs or are participating in clinical trials; * Pregnant and lactating women and to be pregnant women; * The researchers do not consider it appropriate clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV-16 and/or HPV-18 negative conversion rate | 3 months | hr-HPV DNA negative conversion rate will be evaluated at 3 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV-16 and/or HPV-18 negative conversion rate | 6 months | hr-HPV DNA negative conversion rate will be evaluated at 6 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression |
| reinfection at 12 months | 12 months | — |
Countries
China
Contacts
Primary ContactJian Zhao, MD
Outcome results
None listed