Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT04985318
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2021-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011697', 'term': 'Purpura, Thrombotic Thrombocytopenic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585343', 'term': 'caplacizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2034-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment of aTTP with caplacizumab', 'timeFrame': 'Enrollment', 'description': 'Description of the prescription rationale and practice of caplacizumab in the treatment of aTTP'}], 'secondaryOutcomes': [{'measure': 'Stabilization of thrombocyte', 'timeFrame': 'Enrollment', 'description': 'Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of stabilization of thrombocyte. Thrombocyte stabilization is defined as thrombocyte \\> 150 x 10E9/L'}, {'measure': 'Normalization of LDH', 'timeFrame': 'Enrollment', 'description': 'Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of normalization of Lactate dehydrogenase (LDH). Normalization of LDH is defined as LDH below upper limit of normal'}, {'measure': 'Normalization of haptoglobin', 'timeFrame': 'Enrollment', 'description': 'Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of normalization of haptoglobin. Normalization of haptoglobin is defined as haptoglobin above lower limit of normal'}, {'measure': 'Risk factors for complications', 'timeFrame': 'Enrollment', 'description': 'Identification of risk factors for complications'}, {'measure': 'Risk factors for adverse outcomes', 'timeFrame': 'Enrollment', 'description': 'Identification of risk factors for adverse outcomes'}, {'measure': 'Risk factors for persistent autoimmune activity', 'timeFrame': 'Enrollment', 'description': 'Identification of risk factors for persistent autoimmune activity'}, {'measure': 'Parameters for therapy guidance', 'timeFrame': 'Enrollment', 'description': 'Identification of parameters that guide duration and regimen of caplacizumab treatment'}, {'measure': 'Effect of caplacizumab on adjunct treatments with PEX', 'timeFrame': 'Enrollment', 'description': 'Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of therapeutic plasma exchange therapy (PEX)'}, {'measure': 'Effect of caplacizumab on adjunct treatments', 'timeFrame': 'Enrollment', 'description': 'Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of glucocorticoids'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aTTP', 'caplacizumab'], 'conditions': ['Acquired Thrombotic Thrombocytopenic Purpura']}, 'referencesModule': {'references': [{'pmid': '36696206', 'type': 'DERIVED', 'citation': 'Volker LA, Kaufeld J, Balduin G, Merkel L, Kuhne L, Eichenauer DA, Osterholt T, Hagele H, Kann M, Grundmann F, Kolbrink B, Schulte K, Gackler A, Kribben A, Boss K, Potthoff SA, Rump LC, Schmidt T, Muhlfeld AS, Schulmann K, Hermann M, Gaedeke J, Sauerland K, Bramstedt J, Hinkel UP, Miesbach W, Bauer F, Westhoff TH, Bruck H, Buxhofer-Ausch V, Muller TJ, Wendt R, Harth A, Schreiber A, Seelow E, Tolle M, Gohlisch C, Bieringer M, Geuther G, Jabs WJ, Fischereder M, von Bergwelt-Baildon A, Schonermarck U, Knoebl P, Menne J, Brinkkoetter PT; German TTP-Study Group. Impact of first-line use of caplacizumab on treatment outcomes in immune thrombotic thrombocytopenic purpura. J Thromb Haemost. 2023 Mar;21(3):559-572. doi: 10.1016/j.jtha.2022.11.010. Epub 2022 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in Germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in iTTP-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. The rational is to develop new treatment algorithms that optimize overall patient outcome and reduce treatment cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female subjects with confirmed diagnosis of an acute episode of aquired thrombotic thrombocytopenic purpura, who have been treated with one dose of caplacizumab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of an acute episode of acquired thrombotic thrombocytopenic purpura\n* Treatment with at least one single dose of caplacizumab (10 mg i.v. or s.c.)\n* Male or female patients ≥ 18 years of age\n* signed written informed consent\n\nExclusion Criteria:\n\n* Hereditary thrombotic thrombocytopenic purpura\n* disability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04985318', 'acronym': 'REACT-2020', 'briefTitle': 'Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020', 'orgStudyIdInfo': {'id': 'V01-19052020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Registergroup', 'description': 'Patients with acquired Thrombotic Thrombocytopenic Purpura, who have been treated with caplacizumab (Cablivi®)', 'interventionNames': ['Drug: Cablivi®']}], 'interventions': [{'name': 'Cablivi®', 'type': 'DRUG', 'description': 'Intervention with Cablivi® take place outside of the study', 'armGroupLabels': ['Registergroup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Linus Völker, MD', 'role': 'CONTACT', 'email': 'linus.voelker@uk-koeln.de', 'phone': '+49 221 478 86285'}, {'name': 'Lucas Kühne, MD', 'role': 'CONTACT', 'email': 'lucas.kuehne@uk-koeln.de'}, {'name': 'Linus Völker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paul Brinkkötter, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lucas Kühne, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Linus Völker, MD', 'role': 'CONTACT', 'email': 'linus.voelker@uk-koeln.de', 'phone': '+49 221 478 86285'}, {'name': 'Lucas Kühne, MD', 'role': 'CONTACT', 'email': 'lucas.kuehne@uk-koeln.de'}], 'overallOfficials': [{'name': 'Linus Völker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department II of Internal Medicine, University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. MD, Consultant in Nephrology', 'investigatorFullName': 'Prof. Dr. Paul Brinkkoetter', 'investigatorAffiliation': 'University of Cologne'}}}}