Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02085993
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2014-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], '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': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2014-03-11', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful self administration of romiplostim', 'timeFrame': 'First Standard of Care visit post Home Administration Training (range 2-8 weeks)', 'description': 'to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the HAT pack.'}], 'secondaryOutcomes': [{'measure': 'successful reconstitution of romiplostim', 'timeFrame': 'First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)', 'description': 'A yes/no indicator of whether the subject or caregiver reconstitutes romiplostim correctly.'}, {'measure': 'Accuracy in administering the prescribed dose of romiplostim', 'timeFrame': 'First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)', 'description': 'The difference between the prescribed and administered dose of romiplostim, expressed as a %.'}, {'measure': 'Injects romiplostim', 'timeFrame': 'First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)', 'description': 'A yes/no indicator of whether the subject or caregiver injects romiplostim successfully.'}, {'measure': 'Administers romiplostim', 'timeFrame': 'Follow up visits (up to 16 weeks post enrolment)', 'description': 'A yes/no indicator of whether the subject or caregiver administers romiplostim correctly.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['romiplostim,', 'Nplate,', 'immune thrombocytopenic purpura'], 'conditions': ['Immune Thrombocytopenic Purpura']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': "Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.", 'detailedDescription': "This cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the HAT pack. Further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (Additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) Additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ITP patients being treated with romiplostim will be approached for possible study participation. At each participating site, patients that meet the following criteria will be enrolled as a study subject. Adult ITP patients, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim, that has received HAT pack training and is available at a standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training, the patient provides informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) adult ITP patient, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim,\n* (2) has received HAT pack training,\n* (3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training,\n* (4) patient provides informed consent.\n\nExclusion Criteria:\n\n-No exclusion criteria for this observational study'}, 'identificationModule': {'nctId': 'NCT02085993', 'briefTitle': 'Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials', 'orgStudyIdInfo': {'id': '20120269'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single arm', 'description': 'single arm study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '8700', 'city': 'Leoben', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.3765, 'lon': 15.09144}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '34395', 'city': 'Montpellier', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '96317', 'city': 'Kronach', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '24100', 'city': 'Kalamata', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.03913, 'lon': 22.11265}}, {'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '2545 CH', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '5504 DB', 'city': 'Veldhoven', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'zip': '05004', 'city': 'Ávila', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}, {'zip': '28031', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}