Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 6:40 PM
Study NCT ID:
NCT01442168
Status:
TERMINATED
Last Update Posted:
2014-08-19
First Post:
2011-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053626', 'term': 'Atovaquone'}], 'ancestors': [{'id': 'D009285', 'term': 'Naphthoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2011-09-23', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicities according to specified criteria', 'timeFrame': 'During treatment and 14 days post treatment follow-up.'}, {'measure': 'Area under the curve of late stage peripheral blood parasitemia over time (Part 2).', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Uncomplicated Falciparum Malaria', 'Plasmodium falciparum', 'Antimalarial treatment', 'Sevuparin/DF02', 'Adjuvant therapy', 'Malanil', 'Peripheral blood parasitemia', 'Rosette formation', 'Maximum tolerated dose'], 'conditions': ['Malaria, Falciparum']}, 'referencesModule': {'references': [{'pmid': '29244851', 'type': 'DERIVED', 'citation': 'Leitgeb AM, Charunwatthana P, Rueangveerayut R, Uthaisin C, Silamut K, Chotivanich K, Sila P, Moll K, Lee SJ, Lindgren M, Holmer E, Farnert A, Kiwuwa MS, Kristensen J, Herder C, Tarning J, Wahlgren M, Dondorp AM. Inhibition of merozoite invasion and transient de-sequestration by sevuparin in humans with Plasmodium falciparum malaria. PLoS One. 2017 Dec 15;12(12):e0188754. doi: 10.1371/journal.pone.0188754. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation.\n\nThe study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum)\n* Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia\n* Presence of fever defined as \\> 38°C tympanic temperature or a history of fever within the last 24 hours\n\nExclusion Criteria:\n\n* Mixed infection with other Plasmodium species\n* Any criteria of severe or complicated malaria as defined by the WHO, 2010\n* Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin\n* Presence of significant anemia as defined by Hb \\<8 g/dL or Hct \\< 25%\n* A platelet count \\< 50,000/μL\n* Presence of febrile conditions caused by diseases other than malaria'}, 'identificationModule': {'nctId': 'NCT01442168', 'briefTitle': 'Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Modus Therapeutics AB'}, 'officialTitle': 'A Phase I/II, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study of Sevuparin/DF02, as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria', 'orgStudyIdInfo': {'id': 'Sevuparin/DF02_TSM02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevuparin/DF02', 'description': 'Sevuparin/DF02 plus anti-malarial regimen (Malanil®)', 'interventionNames': ['Drug: Sevuparin sodium + atovaquone/proquanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Anti-malarial regimen (Malanil®) alone', 'interventionNames': ['Drug: atovaquone/proquanil']}], 'interventions': [{'name': 'Sevuparin sodium + atovaquone/proquanil', 'type': 'DRUG', 'description': 'Sevuparin 4 times per day and malanil according to label', 'armGroupLabels': ['Sevuparin/DF02']}, {'name': 'atovaquone/proquanil', 'type': 'DRUG', 'description': 'malanil according to label', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mae Ramat', 'state': 'Changwat Tak', 'country': 'Thailand', 'facility': 'Mae Ramat Hospital', 'geoPoint': {'lat': 16.98403, 'lon': 98.51665}}, {'city': 'Mae Sot', 'state': 'Changwat Tak', 'country': 'Thailand', 'facility': 'Maesot General hospital', 'geoPoint': {'lat': 16.71667, 'lon': 98.56667}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Hospital for Tropical Diseases', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Anna Leitgeb, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Modus Therapeutics AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Modus Therapeutics AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}