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The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | subject were treated 3 periods with Yallaferon®; each period has interval 10 days ; one period included Yallaferon application for every other day for 10 times |
|
| Plcaebo | Placebo Comparator | subject were treated 3 periods with Yallaferon® Plcaebo; each period has interval 10 days; one period included Yallaferon application for every other day for 10 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Interferon a-2b Gel | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HPV-16 and/or HPV-18 negative conversion rate | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HPV-16 and/or HPV-18 negative conversion rate | 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 | 6 months |
| HPV-16 and/or HPV-18 negative conversion rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhao, MD | Contact | +861066119025 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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hr-HPV DNA negative conversion rate will be evaluated at 9 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression |
| 9 months |
| HPV-16 and/or HPV-18 negative conversion rate | hr-HPV DNA negative conversion rate will be evaluated at 12 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression | 12 months |
| reinfection at 12 months | 12 months |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |