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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment |
|
| controlled group | Placebo Comparator | received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yallaferon®, the recombinant human interferon α-2b gel | Drug |
| ||
| gel without active ingredient |
| Measure | Description | Time Frame |
|---|---|---|
| difference of HPV-16 and/ or HPV-18 DNA negative conversion rate | 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. | three months |
| Measure | Description | Time Frame |
|---|---|---|
| difference of HPV-16 and/ or HPV-18 DNA negative conversion rate | 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. | six months, nine months and twelve months |
| The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhao | Contact | 010-83572075 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Other |
|
| 1 year |