Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-29 @ 5:44 PM
Study NCT ID:
NCT01824992
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections
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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-04', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference of hr-HPV DNA negative conversion rate', 'timeFrame': 'six months', 'description': 'Primary efficacy endpoint was the difference of hr-HPV DNA negative conversion rate on the 6th month between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups.', 'timeFrame': 'six months', 'description': 'Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups.\n\nEvaluation criteria:\n\nNegative conversion was defined as all positive hr-HPV DNA at baseline turning negative.\n\nNon-negative conversion was defined as at least one of the positive hr-HPV DNA at baseline not turning negative.'}]}, 'conditionsModule': {'conditions': ['HPV Infection']}, 'descriptionModule': {'briefSummary': '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.\n\n285 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 30 to 65 years of age the sex life of female patients;\n2. , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells;\n3. , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive).\n\n15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68\n\nExclusion Criteria:\n\n* (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.'}, 'identificationModule': {'nctId': 'NCT01824992', 'briefTitle': 'Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections', 'organization': {'class': 'INDUSTRY', 'fullName': "Lee's Pharmaceutical Limited"}, 'officialTitle': 'a Multi-sites, Randomized, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection', 'orgStudyIdInfo': {'id': 'LeesPharm_RHI'}, 'secondaryIdInfos': [{'id': 'China State FDA', 'type': 'OTHER', 'domain': 'China State Food and Drug Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'subject only got observation'}, {'type': 'EXPERIMENTAL', 'label': 'Drug', 'description': 'subject were treated with Yallaferon®， the recombinant human interferon α-2b gel', 'interventionNames': ['Drug: Yallaferon®']}], 'interventions': [{'name': 'Yallaferon®', 'type': 'DRUG', 'otherNames': ['Yallaferon®， the recombinant human interferon α-2b gel'], 'armGroupLabels': ['Drug']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Lee's Pharmaceutical Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}