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| ID | Type | Description | Link |
|---|---|---|---|
| China State FDA | Other Identifier | China State Food and Drug Administration |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | No Intervention | subject only got observation | |
| Drug | Experimental | subject were treated with Yallaferon®, the recombinant human interferon α-2b gel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yallaferon® | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| difference of hr-HPV DNA negative conversion rate | Primary efficacy endpoint was the difference of hr-HPV DNA negative conversion rate on the 6th month between the two groups. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups. | Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups. Evaluation criteria: Negative conversion was defined as all positive hr-HPV DNA at baseline turning negative. Non-negative conversion was defined as at least one of the positive hr-HPV DNA at baseline not turning negative. |
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Inclusion Criteria:
15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68
Exclusion Criteria:
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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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| six 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 |