Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT01621256
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2012-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D003638', 'term': 'Deafness'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}], 'ancestors': [{'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000721', 'term': 'Ancrod'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D020791', 'term': 'Venombin A'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D003435', 'term': 'Crotalid Venoms'}, {'id': 'D014757', 'term': 'Viper Venoms'}, {'id': 'D012910', 'term': 'Snake Venoms'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient assessment of change in hearing impairment', 'timeFrame': 'From baseline to Day 8, Day 30 and Day 90'}, {'measure': 'Change in fibrinogen concentration', 'timeFrame': 'From baseline to Day 2 and Day 8'}, {'measure': 'Change in biomarkers', 'timeFrame': 'From baseline to Day 8'}], 'primaryOutcomes': [{'measure': 'Change in PTA (pure tone audiogram) in the affected ear', 'timeFrame': 'From baseline to Day 8'}], 'secondaryOutcomes': [{'measure': 'Change in speech recognition in the affected ear', 'timeFrame': 'From baseline to Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hearing Loss', 'Deafness', 'Hearing Loss, Sensorineural', 'Hearing Disorders', 'Ear Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB\n* Symmetric hearing prior to onset of SSHL\n* Enrollment has to be accomplished within 7 days after SSHL onset\n\nExclusion Criteria:\n\n* Bilateral SSHL\n* Incomplete recovery after previous SSHL\n* Previously existing, known retrocochlear hearing loss\n* Any history of any ear operation or local inflammatory disease in the past one year\n* History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL\n* History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.\n* Treatment with steroids for any reason within the preceding 30 days.\n* Body weight \\> 140 kg"}, 'identificationModule': {'nctId': 'NCT01621256', 'briefTitle': 'Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordmark Arzneimittel GmbH & Co. KG'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)', 'orgStudyIdInfo': {'id': 'NM-V-101'}, 'secondaryIdInfos': [{'id': '2012-000066-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ancrod', 'description': 'Ancrod', 'interventionNames': ['Drug: Ancrod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline solution', 'description': 'Saline solution', 'interventionNames': ['Drug: Saline solution']}], 'interventions': [{'name': 'Ancrod', 'type': 'DRUG', 'otherNames': ['Viprinex', 'NM-V'], 'description': 'Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections', 'armGroupLabels': ['Ancrod']}, {'name': 'Saline solution', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections', 'armGroupLabels': ['Saline solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Site CZ', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Site CZ', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'Site D', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Site D', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Site D', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Landsberg am Lech', 'country': 'Germany', 'facility': 'Site D', 'geoPoint': {'lat': 48.04819, 'lon': 10.88282}}, {'city': 'München', 'country': 'Germany', 'facility': 'Site D', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Martin Canis, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department for Otorhinolaryngology, LM University Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordmark Arzneimittel GmbH & Co. KG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ClinSupport GmbH', 'class': 'INDUSTRY'}, {'name': 'MWI Medizinisches Wirtschaftsinstitut GmbH', 'class': 'UNKNOWN'}, {'name': 'ProjectPharm s.r.o.', 'class': 'UNKNOWN'}, {'name': 'LCR Leading Clinical Research s.r.o.', 'class': 'UNKNOWN'}, {'name': 'X-act Cologne Clinical Research GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}