Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-05 @ 5:00 AM
Study NCT ID:
NCT01317966
Status:
WITHDRAWN
Last Update Posted:
2016-04-20
First Post:
2011-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105308', 'term': 'oprelvekin'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D007293', 'term': 'Inosine Triphosphate'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007292', 'term': 'Inosine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No eligible patients were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2011-03-17', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of platelet response (Complete Response)', 'timeFrame': 'The time frame is up to 14 days per subject', 'description': 'CR. A complete response (CR) was defined as a sustained (≥ 4 months) platelet count ≥ 100×109/L without recurrence of thrombocytopenia'}], 'secondaryOutcomes': [{'measure': 'Evaluation of platelet response (R)', 'timeFrame': 'The time frame is up to 14 days per subject', 'description': 'R. A response (R) was defined as a sustained (≥ 4 months) platelet count ≥ 30×109/L without recurrence of thrombocytopenia'}, {'measure': 'The time of rhIL-11 onset.', 'timeFrame': 'The time frame is up to 28 days per subject.', 'description': 'The time to platelet recovery (defined as the number of days from the start of the study to the first day with a platelet count of ≥30 × 109/L)'}, {'measure': 'DFS', 'timeFrame': 'The time frame is up to 90 days per subject.', 'description': 'The median disease-free survival periods'}, {'measure': 'The number and frequency of IL-11 associated adverse events.', 'timeFrame': 'up to 14 days per subject'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Purpura, Thrombocytopenic, Idiopathic']}, 'referencesModule': {'references': [{'pmid': '20546023', 'type': 'RESULT', 'citation': 'Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients may be male or female, between the ages of 16 \\~ 75 years old.\n2. Isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly.\n3. To show a platelet count ≤ 30 × 109/L, or platelet count ≥ 30 × 109/L with bleeding manifestations at the moment of the first infusion with the study product.\n4. ＥＣＯＧ performance status ≤ 2.\n5. Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.\n6. Patients must be willing and able to give written informed consent.\n\nExclusion Criteria:\n\n1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.\n2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.\n3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.\n4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.\n5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).\n6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.\n7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.\n8. Patients who are deemed unsuitable for the study by the investigator (or coinvestigator).'}, 'identificationModule': {'nctId': 'NCT01317966', 'acronym': 'Incritop', 'briefTitle': 'Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)', 'orgStudyIdInfo': {'id': 'ITP-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rhIL-11Combinating Low-dose Rituximab', 'description': 'rhIL-11 (interleukin-11, Juheli) 50 mcg/kg subcutaneously daily for 14 days\n\nRituximab 100mcg weekly for 4 weeks', 'interventionNames': ['Drug: rhIL-11']}], 'interventions': [{'name': 'rhIL-11', 'type': 'DRUG', 'otherNames': ['Rituximab', 'ITP'], 'description': 'Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab', 'armGroupLabels': ['rhIL-11Combinating Low-dose Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Ming Hou, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ming Hou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Hematology Department', 'investigatorFullName': 'Ming Hou', 'investigatorAffiliation': 'Shandong University'}}}}