Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-29 @ 8:13 AM
Study NCT ID:
NCT02593968
Status:
UNKNOWN
Last Update Posted:
2015-11-02
First Post:
2015-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yallaferon in Chinese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2015-10-30', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV-16 and/or HPV-18 negative conversion rate', 'timeFrame': '3 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'HPV-16 and/or HPV-18 negative conversion rate', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'HPV-16 and/or HPV-18 negative conversion rate', 'timeFrame': '9 months', 'description': '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'}, {'measure': 'HPV-16 and/or HPV-18 negative conversion rate', 'timeFrame': '12 months', 'description': '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'}, {'measure': 'reinfection at 12 months', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HPV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 25 to 65 years of age the sex life of female patients;\n* High-risk HPV 16 and/or 18 positive\n* Agree to sign ICF\n\nExclusion Criteria:\n\n* Cervical intraepithelial neoplasia (CIN);\n* Combined with a severe fungal, trichomonas vaginitis;\n* Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;\n* Allergies or allergy to the drug known ingredients.\n* Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;\n* Pregnant and lactating women and to be pregnant women;\n* The researchers do not consider it appropriate clinical trials.'}, 'identificationModule': {'nctId': 'NCT02593968', 'briefTitle': 'Yallaferon in Chinese Population', 'organization': {'class': 'INDUSTRY', 'fullName': "Lee's Pharmaceutical Limited"}, 'officialTitle': 'a Multi-sites, Randomized, Parallel, Placebo-Controlled Clinical, Pilot Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection', 'orgStudyIdInfo': {'id': 'Zhaoke-1504-Yallaferon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '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', 'interventionNames': ['Drug: Recombinant Human Interferon a-2b Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Plcaebo', 'description': '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', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Recombinant Human Interferon a-2b Gel', 'type': 'DRUG', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Plcaebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Zhao, MD', 'role': 'CONTACT', 'phone': '+86-10-66119025'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jian Zhao, MD', 'role': 'CONTACT', 'phone': '+861066119025'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Lee's Pharmaceutical Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}