Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:58 AM
Study NCT ID:
NCT03875560
Status:
WITHDRAWN
Last Update Posted:
2019-03-14
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IC14 in Adult Patients With Dengue Fever
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'seeking funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (safety, tolerability)', 'timeFrame': '32 days', 'description': 'Number of patients with treatment-related adverse events as classified according to MedDRA'}, {'measure': 'Area under the curve of IC14 serum concentration', 'timeFrame': '14 days', 'description': 'Area under the curve of IC14 serum concentration'}], 'secondaryOutcomes': [{'measure': 'Dengue viral load', 'timeFrame': '32 days', 'description': 'Impact of treatment on dengue viral load measured by quantitative viral load and plasma NS1 viral protein'}, {'measure': 'Fever', 'timeFrame': '32 days', 'description': 'Impact of treatment on duration of fever'}, {'measure': 'Dengue symptom score', 'timeFrame': '32 days', 'description': 'Impact of treatment on dengue symptom severity (0 normal\\] to 24 \\[worst\\])'}, {'measure': 'Disease severity', 'timeFrame': '32 days', 'description': 'Impact of treatment on duration of hospitalization; incidence and duration of intensive care unit admission; and incidence of progression to dengue with warning signs or severe dengue'}, {'measure': 'Mortality', 'timeFrame': '32 days', 'description': 'Impact of treatment on survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dengue Fever']}, 'descriptionModule': {'briefSummary': 'Randomized, double-blind, placebo-controlled, safety, PK/PD and preliminary efficacy study of intravenous IC14 in adult patients in a dengue-endemic region presenting with fever \\> 38°C for \\< 48 hours with a positive NS1 strip assay or reverse-transcriptase polymerase chain reaction assay for dengue virus.', 'detailedDescription': 'The study will be conducted in two parts and will include an open label phase of a single dose of IC14 (Part A) and a randomized phase of multiple doses of IC14 and placebo (Part B). Up to 52 patients will be enrolled in both parts of the study.\n\nPart A will consist of 12 patients given one of three doses of IC14 as a single dose open-label . Each patient must complete 14 days before the enrollment of subsequent patients. Part A subjects will be hospitalized for 4 days. During and at the end of 4-day admission to the clinical research unit, and on Study Days 5, 6, 7, 14, 21 and 32, Part A patients will have their health status assessed. The last subject in Part A must complete 32 days of participation before Part B of the trial is opened.\n\nPart B consists of 40 patients randomized equally to one of 4 dosing regimens which will include a single dose or multiple doses of IC14 or placebo given at different dosing frequencies. In Part B, Cohort 1 and 2 subjects (single dose) will be inpatient for 4 days and Cohort 3 and 4 subjects (four daily doses) will be inpatient for 5 days. During and at the end of the admission to the clinical research unit, and on Study Days 5, 6, 7, 14, 21 and 32, Part B patients will have their health status assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Fever \\> 38°C for \\< 48 hours and clinical presentation consistent with dengue fever.\n* Positive NS1 strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR) assay for dengue virus.\n* Informed consent form signed and dated by the patient.\n* Subject able to give informed consent and able to comply with all study visits and all study procedures.\n* Females of childbearing potential should be using and committed to continue using acceptable birth control methods.\n\n * Sexual abstinence (inactivity) for 1 month prior to screening through study completion; or\n * Intrauterine device (IUD) in place for at least 3 months prior to study through study completion; or\n * Stable hormonal contraception for at least 3 months prior to study through study completion; or\n * Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.\n* To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 3 years since last menses.\n\nExclusion Criteria\n\n* One or more of the following dengue warning signs and symptoms:\n\n * Intense and continuous abdominal pain (referred pain or on palpation);\n * Persistent vomiting;\n * Fluid accumulation (ascites, pleural effusion, or pericardial effusion);\n * Postural hypotension and/or collapse;\n * Painful hepatomegaly \\> two centimeters below the right costal margin;\n * Mucosal bleeding;\n * Major bleeding (hematemesis and/or melena);\n * Lethargy and/or irritability;\n * Diminished urine output;\n * Hypothermia;\n * Progressive increase in hematocrit or 20% above baseline or normal for age;\n * Abrupt drop in platelets;\n * Respiratory discomfort.\n* One or more of the following signs and symptoms of severe dengue, such as:\n\n * Severe plasma extravasation, leading to shock evidenced by one or more of the following:\n * Tachycardia;\n * Cold distal extremities;\n * Weak, thready pulse;\n * Slow capillary refill (\\> 2 seconds);\n * Pulse pressure \\< 20 mmHg;\n * Tachypnea; or\n * Oliguria (\\<1.5 mL/kg/hr).\n * Systolic blood pressure \\< 90 mmHg or decrease \\>40 mmHg;\n * Cyanosis;\n * Fluid accumulation with respiratory discomfort;\n * Severe bleeding; or\n * Severe organ impairment, evidenced by one or more of the following:\n * Liver impairment (AST \\>1000 U/L, international normalized ratio \\>1.5);\n * Renal impairment (serum creatinine ≥1.5 mg/dL); or\n * Myocarditis, pericarditis, or clinical heart failure (by chest x-ray, echocardiography, electrocardiogram, or cardiac enzymes if available).\n* Female who is pregnant, lactating or of childbearing potential.\n* Self-reported or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the previous 3 months).\n* Prior vaccination against dengue fever.\n* Significant chronic illness that, in the opinion of the Investigator, would interfere with study validity, conduct or completion.'}, 'identificationModule': {'nctId': 'NCT03875560', 'briefTitle': 'IC14 in Adult Patients With Dengue Fever', 'organization': {'class': 'INDUSTRY', 'fullName': 'Implicit Bioscience'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of IC14 in Adult Patients With Dengue Fever', 'orgStudyIdInfo': {'id': 'EDF-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A/Single Dose', 'description': 'IC14 0.5, 1.0 or 2.0 mg/kg IV as a single dose (subjects are assigned and not randomized to this arm. When Part A is complete, Enrollment to Part B will commence).', 'interventionNames': ['Biological: IC14']}, {'type': 'EXPERIMENTAL', 'label': 'Part B/Cohort 1', 'description': 'IC14 4 mg/kg/day IV or placebo IV x 1 day.', 'interventionNames': ['Biological: IC14', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B/Cohort 2', 'description': 'IC14 8 mg/kg/day IV or placebo IV x 1 day.', 'interventionNames': ['Biological: IC14', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B/Cohort 3', 'description': 'IC14 2 mg/kg/day IV x 1 day followed by IC14 1 mg/kg/day IV x 3 days or placebo IV daily for 4 days.', 'interventionNames': ['Biological: IC14', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B/Cohort 4', 'description': 'IC14 4 mg/kg/day IV x 1 day followed by IC14 2 mg/kg/day IV x 3 days or placebo IV daily for 4 days.', 'interventionNames': ['Biological: IC14', 'Drug: Placebo']}], 'interventions': [{'name': 'IC14', 'type': 'BIOLOGICAL', 'description': 'recombinant chimeric anti-human CD14 monoclonal antibody', 'armGroupLabels': ['Part A/Single Dose', 'Part B/Cohort 1', 'Part B/Cohort 2', 'Part B/Cohort 3', 'Part B/Cohort 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inactive', 'armGroupLabels': ['Part B/Cohort 1', 'Part B/Cohort 2', 'Part B/Cohort 3', 'Part B/Cohort 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jan Agosti, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Implicit Bioscience'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Implicit Bioscience', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}