Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-04 @ 6:14 AM
Study NCT ID:
NCT01619969
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2012-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celgosivir as a Treatment Against Dengue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C070715', 'term': 'celgosivir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-28', 'studyFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virological Log Reduction (Virological Endpoint)', 'timeFrame': '4 days'}, {'measure': 'Fever Reduction (Clinical Endpoint)', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'Safety-Proportion of patients experiencing adverse events and serious adverse events', 'timeFrame': '14 days', 'description': 'The proportion of patients experiencing adverse events and serious adverse events'}, {'measure': 'Quantitative NS1 and NS1 clearance', 'timeFrame': '14 days', 'description': 'NS1 non-structural protein 1'}, {'measure': 'Hematology', 'timeFrame': '14 days', 'description': 'Leukocytes, platelets, hematocrit'}, {'measure': 'Pharmacokinetics - Clearance of drug (L/hr)', 'timeFrame': '5 days', 'description': 'Clearance of drug (L/hr)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dengue Fever']}, 'referencesModule': {'references': [{'pmid': '27509020', 'type': 'DERIVED', 'citation': 'Sung C, Wei Y, Watanabe S, Lee HS, Khoo YM, Fan L, Rathore AP, Chan KW, Choy MM, Kamaraj US, Sessions OM, Aw P, de Sessions PF, Lee B, Connolly JE, Hibberd ML, Vijaykrishna D, Wijaya L, Ooi EE, Low JG, Vasudevan SG. Extended Evaluation of Virological, Immunological and Pharmacokinetic Endpoints of CELADEN: A Randomized, Placebo-Controlled Trial of Celgosivir in Dengue Fever Patients. PLoS Negl Trop Dis. 2016 Aug 10;10(8):e0004851. doi: 10.1371/journal.pntd.0004851. eCollection 2016 Aug.'}, {'pmid': '24877997', 'type': 'DERIVED', 'citation': 'Low JG, Sung C, Wijaya L, Wei Y, Rathore APS, Watanabe S, Tan BH, Toh L, Chua LT, Hou Y, Chow A, Howe S, Chan WK, Tan KH, Chung JS, Cherng BP, Lye DC, Tambayah PA, Ng LC, Connolly J, Hibberd ML, Leo YS, Cheung YB, Ooi EE, Vasudevan SG. Efficacy and safety of celgosivir in patients with dengue fever (CELADEN): a phase 1b, randomised, double-blind, placebo-controlled, proof-of-concept trial. Lancet Infect Dis. 2014 Aug;14(8):706-715. doi: 10.1016/S1473-3099(14)70730-3. Epub 2014 May 28.'}]}, 'descriptionModule': {'briefSummary': 'This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.', 'detailedDescription': 'Patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be enrolled and admitted to the Investigational Medicine Unit. Patients will be randomized 1:1 to celgosivir or placebo. Capsules of placebo or celgosivir will be administered for 5 days. While in hospital, daily clinical exams will be conducted, and blood samples will be collected for viral load, quantitative NS1, hematology, clinical chemistry, cytokine levels and pharmacokinetics (PK). Safety assessments will be conducted. At discharge on Study Day 5, patients will be asked to return on Study Days 7, 10, and 15 for blood sampling and safety assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Fever of ≥ 38°C of ≤ 48 hr duration.\n* At least two of the following criteria indicating probable dengue infection:\n\n * Live or work in or recent travel to dengue endemic area\n * Nausea and vomiting\n * Presence of rash\n * Aches and pains, including headache, or retro-orbital, muscle or joint pain\n* Positive NS1 strip assay\n\nMain Exclusion Criteria:\n\n* Clinical signs and symptoms for severe dengue\n* Patients with certain abnormal laboratory values\n* History of presently active intestinal disorders\n* Severe diarrhea\n* Current usage of anticoagulant drugs\n* Other clinically significant acute illness\n* History of severe drug and/or food allergies\n* Exposure to investigational agent within 30 days prior to study drug administration\n* Clinically significant abnormal physical exam unrelated to dengue fever\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01619969', 'acronym': 'CELADEN', 'briefTitle': 'Celgosivir as a Treatment Against Dengue', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever', 'orgStudyIdInfo': {'id': '2012/025/E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celgosivir', 'interventionNames': ['Drug: celgosivir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'celgosivir', 'type': 'DRUG', 'otherNames': ['Bu-Cast'], 'description': '100 mg capsules, 400 mg loading dose 200 mg bid', 'armGroupLabels': ['Celgosivir']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Capsules of identical appearance containing starch', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Subhash Vasudevan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duke-NUS Graduate Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke-NUS Graduate Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}