Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT02429505
Status:
WITHDRAWN
Last Update Posted:
2020-08-28
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007896', 'term': 'Leishmaniasis'}], 'ancestors': [{'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C039128', 'term': 'miltefosine'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-12-30', 'size': 1008175, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-20T12:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'This study was COMPLETED, but no patients were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2015-04-24', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients cured', 'timeFrame': '6 months', 'description': 'Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse effects', 'timeFrame': '6 months', 'description': 'Adverse events including symptoms and laboratory parameters (if available)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leishmaniasis']}, 'descriptionModule': {'briefSummary': 'This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine (Impavido) in the US and who weigh \\> 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.', 'detailedDescription': "Objective: The purpose of this observational study is to fulfill PMR 2127-4 for the miltefosine NDA (204684): implement a higher-weight-patient registry for the time period Mar 2015-Mar 2020.\n\nStudy Design: This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with Impavido in the US and who weigh \\> 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.\n\nPopulation: Leishmaniasis patients treated with Impavido who weigh more than 75 kg.\n\nDrug Product:\n\nDrug name: Impavido (50 mg capsules). Dosing regimen: as per the Impavido Product Label\n\nStudy Procedures: Patients who weigh more than 75 kg will become aware of the Impavido Higher-Weight Patient Registry via the Impavido website. By calling 1-866-588-5405, the patient will be connected to the Impavido Higher-Weight Patient Registry Coordinating Center. A trained staff member will acquaint the patient with the goals and procedures of the study. If the patient tentatively agrees to participate in the study over the telephone, the patient will be mailed information forms, the Consent/Assent Forms, and the Consent for the patient's physician to release medical information. Receipt of the two signed Consent and/or Assent Forms by the Coordinating Center will signify patient consent. The Coordinating Center will contact the patient's physician at the end of treatment, and at 1, 3, and 6 months after completing treatment, to collect data on efficacy and adverse effects (only during treatment).\n\nSample Size and Study Duration: Estimated 3-10 patients per year for 5 years.\n\nOutcome Parameters:\n\nEfficacy Adverse effects\n\nAnalysis: Baseline data, compliance to prescribed treatment, and outcomes will be reported for individual patients and for all patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'leishmaniasis patients who are administered miltefosine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Did the subject give consent to collect data from her or her physician?\n2. Was the subject treated for leishmaniasis with miltefosine?\n3. Does the subject weigh more than 75 kg?\n\nExclusion Criteria:\n\n\\[none\\]'}, 'identificationModule': {'nctId': 'NCT02429505', 'briefTitle': 'Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Knight Therapeutics (USA) Inc'}, 'officialTitle': 'Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry', 'orgStudyIdInfo': {'id': 'IMP 2127-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Miltefosine', 'description': 'Miltefosine : target of 2.5 mg/kg/day for 28 days. Patients 45 kg or greater were to receive one 50 mg capsule 3 times daily for 28 consecutive days. This prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine in the United States who weighed \\>75 kg could volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.', 'interventionNames': ['Drug: Miltefosine']}], 'interventions': [{'name': 'Miltefosine', 'type': 'DRUG', 'otherNames': ['Impavido'], 'description': 'miltefosine: target 2.5 mg/kg/day for 28 days', 'armGroupLabels': ['Miltefosine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20837', 'city': 'Poolesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Fast-Track Drugs and Biologics, LLC', 'geoPoint': {'lat': 39.14594, 'lon': -77.41693}}], 'overallOfficials': [{'name': 'Janet Ransom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fast Track Drugs and Biologics LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Knight Therapeutics (USA) Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}