Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections
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|ClinicalTrials.gov Identifier: NCT02801383|
Recruitment Status : Unknown
Verified June 2016 by Lee's Pharmaceutical Limited.
Recruitment status was: Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cervical HPV-16 and / or HPV-18 Infection||Drug: Yallaferon®， the recombinant human interferon α-2b gel Other: gel without active ingredient||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
Active Comparator: Treatment group
received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment
Drug: Yallaferon®， the recombinant human interferon α-2b gel
Placebo Comparator: controlled group
received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment
Other: gel without active ingredient
- difference of HPV-16 and/ or HPV-18 DNA negative conversion rate [ Time Frame: 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.
- difference of HPV-16 and/ or HPV-18 DNA negative conversion rate [ Time Frame: 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 [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801383
|Contact: Jian Zhao||010-83572075|
|Peking University First Hospital||Recruiting|
|Contact: Jian Zhao, M.D. 010-83572075|