Cervical HPV-16 and / or HPV-18 Infection
Conditions
Brief 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.
Interventions
DRUGYallaferon®， the recombinant human interferon α-2b gel
OTHERgel without active ingredient
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 with the sex life of female patients; * HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.
Exclusion criteria
* Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer; * Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients; * Associated with acute, severe bacterial or viral infection; * Autoimmune diseases; * Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs; * Allergies or allergy to the drug known ingredients; * History of suffering CNS diseases, epilepsy and/or psychological disorder; * Pregnant and lactating women; * The researchers do not consider it appropriate clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference of HPV-16 and/ or HPV-18 DNA negative conversion rate | three months | Primary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 3th month between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference of HPV-16 and/ or HPV-18 DNA negative conversion rate | six months, nine months and twelve months | Secondary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 6th, 9th and 12th month between the two groups. |
| The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups | 1 year | — |
Countries
China
Contacts
Primary ContactJian Zhao
Outcome results
None listed