Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00902018
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2009-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520809', 'term': 'eltrombopag'}, {'id': 'C488777', 'term': 'romiplostim'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbussel@med.cornell.edu', 'phone': '22-746-3474', 'title': 'Dr James Bussel', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'data for investigation collected over 2 weeks in all patients: 7 with eltrombopag alone and 3 with eltrombopag first and, then after a washout period, romiplostim later this would be 10 for eltrombopag and 3 for romiplostim additional medication provided as incentive to patients to enter the study there was a single blood draw without incident in the 10 healthy volunteers', 'description': 'patients were asked for concomitant meds and Adverse Events on every visit', 'eventGroups': [{'id': 'EG000', 'title': 'Eltrombopag', 'description': 'Ten participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Romiplostim', 'description': 'Three Participants who had been on eltrombopag will undergo a washout period and will be treated with Romiplostim 10 ug/kg/weekly for 2 weeks. Participants on Romiplostim will be monitored three times a week for two weeks.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Volunteers', 'description': 'single blood draw in healthy controls/volunteers', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'increase in LFTs', 'notes': 'increase in ALT/AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients for Whom Eltrombopag Increases the Platelet Count to > 50,000/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Arm', 'description': 'Participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.'}, {'id': 'OG001', 'title': 'Eltrombopag Then Romiplostim', 'description': 'Three Participants from Eltrombopag arm will undergo second washout period and will be treated with Romiplostim 10 ug/kg/weekly for 2 weeks. Participants on Romiplostim will be monitored three times a week for two weeks exactly like when they received Eltrombopag.'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': '10 normal volunteers for a single blood draw'}], 'classes': [{'title': 'pts with platelet counts > 50,000/uL on day 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pts with platelet counts > 50,000/uL on day 15', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'platelet counts on days 8 and 15', 'description': 'number of patients in whom Platelet Counts measured on days 8 and 15 after eltrombopag treatment increase to \\> 50,000/uL counts on other days are just used to be sure the ones on days 8 and 15 are reasonably accurate and representative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '0 participants were analyzed in the healthy control arm because healthy controls did not have any blood draws on day 8 and 15 or receive the intervention and hence data was not collected for these participants'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Received Romiplostim and Increased Their Platelet Counts to > 50,000/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Romiplostim Treated Patients', 'description': '3 patients treated with romiplostim 10 micrograms/kg weekly twice with weekly platelet counts on days 1, 8, and 15'}], 'classes': [{'title': 'plt cts > 50,000/uL on day 8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'plt cts > 50,000/uL on day 15', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'platelet counts on days 8 and 15', 'description': 'number of participants in whom platelet counts measured on day 8 and day 15 after treatment(s) with romiplostim 10 micrograms/kg on days 1 and 8', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'How Many Patients Developed SAEs and/or Abnormal Liver Tests to a Level > 2 Times the Upper Limit of Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': '10 ITP patients were treated with daily oral eltrombopag 75mg for 2 weeks and testing was done at weekly intervals 3 times they then were allowed to receive long-term eltrombopag\n\nEltrombopag: The 10 subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times a week for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months.'}, {'id': 'OG001', 'title': 'Romiplostim', 'description': '3 patients, who first received eltrombopag, were treated with romiplostim 10 micrograms/kg weekly for 2 weeks with the same testing done at weekly intervals three times\n\nRomiplostim: three of the patients treated with eltrombopag will be treated with weekly romiplostim at a dose of 10 micrograms/kg weekly for 2 weeks with testing at weekly intervals for 3 times and blood counts monitored 3 times per week'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': 'healthy controls: single blood draw for all measures included in the intervention arms'}], 'classes': [{'title': 'number of patients with Abnl LFTs on day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'number of patients Abnl LFTs on day 15', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'number of patients with an SAE on day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'number of patients with an SAE on day 15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'on days 8 and 15', 'description': 'To assess the safety of eltrombopag, in particular the number of patients with serious adverse events and/or abnormal liver tests reaching a level of more than twice the upper limit of normal for the test these outcomes were assessed periodically for liver tests but other SAEs were not systematically assessed but only with complaints or events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '0 participants were analyzed in the healthy controls arm because healthy controls did not have any blood draw on day 8 and 15 or receive the intervention and hence data was not collected for these participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline After Eltrombopag Treatment of Platelet Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Arm', 'description': 'Participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.'}, {'id': 'OG001', 'title': 'Eltrombopag Then Romiplostim', 'description': 'Three Participants were treated identically as per the eltrombopag arm and, several months later, would undergo a second washout period and were treated with Romiplostim 10 ug/kg/weekly for 2 weeks.\n\nParticipants on Romiplostim will be monitored as were the Eltrombopag participants for 2 weeks.'}, {'id': 'OG002', 'title': 'Healthy Control Group', 'description': '10 Control Participants without thrombocytopenia or any major health issues were enrolled to provide laboratory comparison data to the ITP patients with a single blood draw for platelet counts, IPF, large platelets, IC50 for apoptosis, AKT pathway intermediates.'}], 'classes': [{'title': 'platelet apoptosis increase on day 8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'platelet apoptosis increase on day 15', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'increase in intracellular AKT intermediates day 8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'increase in intracellular AKT intermediates day 15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'increase in A-IPF day 8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'increase in A-IPF day 15', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'increase in large platelets day 8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'increase in large platelets day 15', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'testing on days 8 and 15', 'description': 'Samples were drawn weekly for 2 weeks on days 1, 8, and 15 for the treatment arms and day 1 for the healthy control group. Platelet samples were exposed to small molecule Bcl-xL inhibitor, ABT-737 ex-vivo to explore resistance to apoptosis by determining the half maximal inhibitory concentration (IC50) which was measured for each weekly sample drawn. If the half maximal concentration of ABT737 was increased this meant increased resistance to apoptosis.\n\nThe AKT pathway intermediates were measured since these would indicate the mechanism of the platelet resistance to apoptosis so the two sets of measures confirm each other the AIPF is a measure of how many new platelets are made and the large platelets are similar to that', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '0 participants were analyzed in the healthy controls arm because healthy controls did not have any blood draw on day 8 and 15 or receive the intervention and hence data was not collected for these participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eltrombopag', 'description': 'Promacta (eltrombopag): Subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times a week for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months.\n\nfirst blood draw before taking eltrombopag'}, {'id': 'FG001', 'title': 'Eltombopag Then Romiplostim', 'description': 'patients who receive eltrombopag and then are treated with romiplostim (nplate) to ascertain parallelism between the two agents'}, {'id': 'FG002', 'title': 'Healthy Volunteer', 'description': 'one blood draw only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'patients with persistent or chronic ITP willing to undergo washout period and then multiple visits (7) in 2 weeks period including 3 larger blood draws'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Eltrombopag Arm', 'description': 'Participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.'}, {'id': 'BG001', 'title': 'Eltrombopag Receiving Romiplostim', 'description': 'Three Participants who had been on eltrombopag in the past will undergo a washout period and will be treated with Romiplostim 10 ug/kg/weekly for 2 weeks. Participants on Romiplostim will be monitored three times a week for two weeks.'}, {'id': 'BG002', 'title': 'Healthy Volunteers', 'description': 'single blood draw in healthy volunteers (controls)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '10 patients receive eltrombopag and 3 of these go on to receive romiplostim'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '10 patients on eltrombopag and 3 were then treated with romiplostim 10 healthy controls'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2009-05-08', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-15', 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline After Eltrombopag Treatment of Platelet Parameters', 'timeFrame': 'testing on days 8 and 15', 'description': 'Samples were drawn weekly for 2 weeks on days 1, 8, and 15 for the treatment arms and day 1 for the healthy control group. Platelet samples were exposed to small molecule Bcl-xL inhibitor, ABT-737 ex-vivo to explore resistance to apoptosis by determining the half maximal inhibitory concentration (IC50) which was measured for each weekly sample drawn. If the half maximal concentration of ABT737 was increased this meant increased resistance to apoptosis.\n\nThe AKT pathway intermediates were measured since these would indicate the mechanism of the platelet resistance to apoptosis so the two sets of measures confirm each other the AIPF is a measure of how many new platelets are made and the large platelets are similar to that'}], 'primaryOutcomes': [{'measure': 'Number of Patients for Whom Eltrombopag Increases the Platelet Count to > 50,000/uL', 'timeFrame': 'platelet counts on days 8 and 15', 'description': 'number of patients in whom Platelet Counts measured on days 8 and 15 after eltrombopag treatment increase to \\> 50,000/uL counts on other days are just used to be sure the ones on days 8 and 15 are reasonably accurate and representative'}, {'measure': 'Number of Patients Who Received Romiplostim and Increased Their Platelet Counts to > 50,000/uL', 'timeFrame': 'platelet counts on days 8 and 15', 'description': 'number of participants in whom platelet counts measured on day 8 and day 15 after treatment(s) with romiplostim 10 micrograms/kg on days 1 and 8'}], 'secondaryOutcomes': [{'measure': 'How Many Patients Developed SAEs and/or Abnormal Liver Tests to a Level > 2 Times the Upper Limit of Normal', 'timeFrame': 'on days 8 and 15', 'description': 'To assess the safety of eltrombopag, in particular the number of patients with serious adverse events and/or abnormal liver tests reaching a level of more than twice the upper limit of normal for the test these outcomes were assessed periodically for liver tests but other SAEs were not systematically assessed but only with complaints or events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ITP'], 'conditions': ['Immune Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '25132654', 'type': 'RESULT', 'citation': 'Mitchell WB, Pinheiro MP, Boulad N, Kaplan D, Edison MN, Psaila B, Karpoff M, White MJ, Josefsson EC, Kile BT, Bussel JB. Effect of thrombopoietin receptor agonists on the apoptotic profile of platelets in patients with chronic immune thrombocytopenia. Am J Hematol. 2014 Dec;89(12):E228-34. doi: 10.1002/ajh.23832. Epub 2014 Sep 2.'}], 'seeAlsoLinks': [{'url': 'http://onlinelibrary.wiley.com/doi/10.1002/ajh.23832/abstract', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further evaluate the effects that eltrombopag (and romiplostim) have on platelets in subjects with chronic ITP. Eltrombopag is approved by the Food and Drug Administration (FDA) for the treatment of low platelets in patients with chronic ITP. It is being further studied by GlaxoSmithKline (now Novartis) in other conditions associated with low platelets. This research study is being done because eltrombopag has been shown to increase platelet counts in a different way than other therapies for ITP. The investigators want to further study how eltrombopag and romiplostim affect subjects and their platelets to determine how the study drug should best be used in ITP treatment.', 'detailedDescription': 'The B-cell lymphoma extra large (Bcl-xL/Bak) balance has been identified as an intrinsic mechanism that is critical in determining platelet lifespan (Mason, Cell 2007). There is evidence that Bcl-xL protein expression in megakaryocytes is regulated by Thrombopoietin (TPO) mediated activation of Akt pathways mediated by Jak2 and Stat 5 (possibly by Stat 3 as well). (e.g., Kozuma et. al., Journal of Thrombosis and Haemostasis). Little is known about the Bcl-xL / Bak axis in patients with ITP, or the effect of TPO-R stimulation on platelet survival in patients with ITP. The TPO effect may be a result of stimulation of thrombopoietin-receptor (TPO-R) signalling in megakaryocytes altering the packaging of Bcl-xl into platelets, or be a direct effect of platelet TPO-R stimulation as described above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has signed and dated a written informed consent\n* Male or female adults (≥18 years) diagnosed with either primary ITP according to the American Society for Hematology or British Committee for Standards in Haematology (ASH/BCSH) guidelines \\[Blood, 1996; British Journal of Haematology, 2003\\] for at least three months prior to study entry or with ITP secondary to Evans syndrome, systemic lupus erythematosus (SLE), or Common Variable Immunodeficiency (including hypogammaglobulinemia).\n* Subjects must have responded with a platelet count \\> 30,000/µL to a previous ITP therapy including thrombopoietic agents.\n* Platelet count \\< 30,000/µL\n* Female subjects of childbearing potential are practicing an acceptable method of contraception or are completely abstinent from intercourse.\n\nExclusion Criteria:\n\n* Active infection\n* Previously treated with thrombopoietic agents IF either no response at a therapeutic dose (peak platelet count \\< 50k) OR treatment with the agent within the past 4 weeks\n* Currently treated with concomitant ITP medication that has not been stable in dose for at least 2 weeks - only prednisone, azathioprin, and danazol are allowed.\n* Female subjects who are nursing or pregnant\n* Thrombosis of any kind within past 6 months or on blood thinners because of thrombosis.\n* Intravenous Immunoglobulin (IVIG), IV anti-D, bolus corticosteroids or vinca alkaloids within the past week\n* Other cytotoxic or immunosuppressive ITP therapy within the past 8 weeks or rituximab within the past 12 weeks\n* Active non-dermatologic malignancy defined as presence of known tumor ie. visible by radiography or evident on blood or bone marrow testing OR receiving chemotherapy within past 2 months\n* Hemoglobin \\< 10 gm/dl or white blood cell count \\< 2,500/ul\n* Liver function tests (ALT, Aspartate Aminotransferase (AST), or total bilirubin) \\> three times upper limit of normal (ULN)\n* Creatinine \\> two times upper limit of normal (ULN)'}, 'identificationModule': {'nctId': 'NCT00902018', 'briefTitle': 'Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) Pathway', 'orgStudyIdInfo': {'id': '0809009980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eltrombopag', 'description': '10 ITP patients were treated with daily oral eltrombopag 75mg for 2 weeks and complete testing was done at weekly intervals 3 times they then were allowed to receive long-term eltrombopag', 'interventionNames': ['Drug: Eltrombopag']}, {'type': 'EXPERIMENTAL', 'label': 'romiplostim', 'description': '3 of the patients who received eltrombopag were also treated with romiplostim 10 micrograms/kg weekly for 2 weeks with the same complete testing done at weekly intervals three times after a washout period \\> 1 month they then resumed long-term eltrombopag', 'interventionNames': ['Drug: Romiplostim']}, {'type': 'SHAM_COMPARATOR', 'label': 'healthy controls', 'description': 'no intervention single blood draw with complete studies', 'interventionNames': ['Other: healthy controls']}], 'interventions': [{'name': 'Eltrombopag', 'type': 'DRUG', 'otherNames': ['revolade, promacta'], 'description': 'The 10 subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times, weekly, for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months.', 'armGroupLabels': ['eltrombopag']}, {'name': 'Romiplostim', 'type': 'DRUG', 'otherNames': ['amg531, nplate'], 'description': 'three of the patients treated with eltrombopag will be treated with weekly romiplostim at a dose of 10 micrograms/kg weekly for 2 weeks with testing at weekly intervals for 3 times', 'armGroupLabels': ['romiplostim']}, {'name': 'healthy controls', 'type': 'OTHER', 'otherNames': ['volunteers not receiving any treatment'], 'description': 'single blood draw for all measures included in the intervention arms', 'armGroupLabels': ['healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'James B. Bussel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}