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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000031940 |
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Date of registration:
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28/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis
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Scientific title:
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Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis - Autologous hematopoietic stem cell transplantation for severe systemic sclerosis |
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Date of first enrolment:
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2010/09/07 |
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Target sample size:
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24 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036479 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hiroki Mitoma |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Japan |
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Telephone:
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092-641-1151 |
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Email:
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mitoma@intmed1.med.kyushu-u.ac.jp |
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Affiliation:
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Kyushu University Hospital Department of Clinical Immunology and Rheumatology / Infectious Disease |
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Name:
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Koichi Akashi |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Japan |
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Telephone:
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092-641-1151 |
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Email:
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akashi@med.kyushu-u.ac.jp |
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Affiliation:
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Kyushu University Hospital Department of Hematology, Oncology & Cardiovascular medicine, Department of Clinical Immunology and Rheumatology / Infectious Disease |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: A patient with one of the following severe organ complication, a) Heart: uncontrollable arrhythmia, uncontrollable heart failure, LVEF is less than 50% in cardiac ultrasound examination, moderate or more pulmonary hypertension (mean pulmonary artery pressure is 40 mmHg or more) b) Lung: PaO2 is less than 60 mmHg at room air, %VC is less than 50%. %DLCO is less than 20%. c) Kidney: renal glomerular filtration rate is less than 40 ml/min, serum creatinine is 2 mg/dl or more. d) Uncontrolled malignant neoplasm e) Uncontrollable infection. f) Cyclophosphamide is used more than 10 g in total.
Age minimum:
16years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Systemic sclerosis
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Intervention(s)
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Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells
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Primary Outcome(s)
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Event-free survival at 2 years after transplantation
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Secondary Outcome(s)
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Event-free survival at 1, 3 and 5 years after transplantation Improvement of modified Rodnan total skin thickness score at 1, 3 and 5 years after transplantation Improvement of %VC at 1, 3 and 5 years after transplantation Safety, Progression-free survival, Overall survival
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Source(s) of Monetary Support
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Japan Agency for Medical Research and Development
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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