Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-01 @ 12:11 AM
Study NCT ID:
NCT04007120
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2019-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study of Inhaled RVT-1601 in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2019-06-28', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in heart rate', 'timeFrame': 'Pre-dose and 15 minutes post-dose', 'description': 'Assessment of heart rate (beats/min)'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Pre-dose and 15 minutes post-dose', 'description': 'Assessment of systolic and diastolic blood pressure (mmHg)'}, {'measure': 'Change in oxygenation', 'timeFrame': 'Pre-dose and 15 minutes post-dose', 'description': 'Assessment of peripheral capillary oxygen saturation (SpO2)'}], 'secondaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax)', 'timeFrame': '30 minutes post-dose', 'description': 'Assessment of peak plasma concentration of RVT-1601'}, {'measure': 'Total urine excretion', 'timeFrame': '8 hours post-dose', 'description': 'Assessment of total urine content of RVT-1601'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Morbidities of Prematurity (RMP)']}, 'descriptionModule': {'briefSummary': 'Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term. In the short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia (BPD), the second most common chronic pediatric respiratory disease after asthma. In the long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital, preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor visits, and hospitalizations for respiratory infections) and resource use, which in turn predisposes infants to the development of lung diseases in childhood and adulthood, including airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There is a significant unmet need for safe and efficacious approaches in the prevention and treatment of respiratory morbidities of prematurity.\n\nThe study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face mask.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '32 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants between 32 weeks 0 days and 34 weeks 6 days of PMA\n* Born between 24 weeks 0 days and 29 weeks 6 days of estimated GA\n* Requiring minimal or no respiratory support (i.e., supplemental oxygen with \\<2 liters per minute of nasal cannula flow acceptable)\n* Body weight appropriate for gestational age\n* Written informed consent obtained from at least one of the parents or legal guardians\n\nExclusion Criteria:\n\n* Requiring invasive or noninvasive respiratory support (e.g., mechanical ventilation, CPAP)\n* Clinically unstable (i.e. unable to maintain SpO2 between 90-95 % , escalating respiratory support in the past 24 hours)\n* Major congenital anomaly (chromosomal, renal, cardiac, hepatic, neurologic or pulmonary malformations)\n* Significant cardiac disorder (i.e., pulmonary hypertension)\n* History of major surgical procedure\n* Any condition that would preclude receiving study drug or performing any study-related procedures\n* Participation in any other investigational drug study\n* History of hypersensitivity or intolerance to cromolyn sodium'}, 'identificationModule': {'nctId': 'NCT04007120', 'briefTitle': 'Open-label Study of Inhaled RVT-1601 in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Respivant Sciences Inc.'}, 'officialTitle': 'Open-label Study to Assess the Safety, Tolerability, Feasibility, and Pharmacokinetics of Inhaled RVT-1601 in Preterm Infants at High-risk for Long-term Respiratory Morbidities', 'orgStudyIdInfo': {'id': 'RVT1601-RMP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RVT-1601 Low Dose', 'description': 'Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer', 'interventionNames': ['Drug: RVT-1601']}, {'type': 'EXPERIMENTAL', 'label': 'RVT-1601 Mid Dose', 'description': 'Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer', 'interventionNames': ['Drug: RVT-1601']}], 'interventions': [{'name': 'RVT-1601', 'type': 'DRUG', 'description': 'Inhaled RVT-1601 administered once daily over two days', 'armGroupLabels': ['RVT-1601 Low Dose', 'RVT-1601 Mid Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women & Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Respivant Sciences GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Respivant Sciences Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}