Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-02 @ 1:56 PM
Study NCT ID:
NCT00979251
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2009-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053139', 'term': 'Oseltamivir'}, {'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2014-02-14', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2009-09-16', 'dispFirstSubmitQcDate': '2014-03-17', 'studyFirstSubmitQcDate': '2009-09-16', 'dispFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to clearing of viral shedding', 'timeFrame': 'Baseline, Days 2, 4, 6, 8, 10, 15 and 20'}], 'secondaryOutcomes': [{'measure': 'Time to alleviation of influenza clinical symptoms', 'timeFrame': 'Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38'}, {'measure': 'Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza', 'timeFrame': 'Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38'}, {'measure': 'Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment', 'timeFrame': 'Baseline, Days 2, 4, 6, 8, 10, 15, 20'}, {'measure': 'Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)', 'timeFrame': 'Through day 210'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza', 'Immunocompromised', 'HIV', 'History of transplant'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed influenza A by rapid antigen testing\n* Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive\n* Clinical diagnosis of influenza\n* Onset of illness within 5 days\n* Male and female subjects agree to contraception through 24 weeks after last dose\n\nExclusion Criteria:\n\n* Received more than 1 dose of antiviral agents\n* Critically ill\n* Creatinine clearance less than 80 mg/mL\n* Females who are pregnant and males whose female partners are pregnant\n* Received live attenuated virus vaccine within 3 weeks'}, 'identificationModule': {'nctId': 'NCT00979251', 'acronym': 'PO206', 'briefTitle': 'Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adamas Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin With Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects', 'orgStudyIdInfo': {'id': 'ADS-TCAD-PO206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADS-8902', 'description': 'Amantadine and Ribavirin administered with Oseltamivir phosphate', 'interventionNames': ['Drug: ADS-8902']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'Oseltamivir Phosphate', 'interventionNames': ['Drug: Oseltamivir Phosphate']}], 'interventions': [{'name': 'Oseltamivir Phosphate', 'type': 'DRUG', 'otherNames': ['Tamiflu'], 'description': 'Oseltamivir Phosphate, q8h', 'armGroupLabels': ['Comparator']}, {'name': 'ADS-8902', 'type': 'DRUG', 'otherNames': ['Amantadine Hydrochloride', 'Rebetol®', 'Tamiflu®'], 'description': 'Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h', 'armGroupLabels': ['ADS-8902']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'NSW 2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': 'QLD 4029', 'city': 'Herston', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Adamas Investigational Site'}, {'zip': 'QLD 4029', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Adamas Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Adamas Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adamas Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}