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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-UMIN000016320 |
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Date of registration:
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24/01/2015 |
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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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Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease
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Scientific title:
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Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease - Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease |
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Date of first enrolment:
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2014/09/18 |
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Target sample size:
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6 |
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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=R000018939 |
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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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Not selected
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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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Yukiko Iwasaki |
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Address:
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7-3-1 Hongou, Bunkyo-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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yunyan-todai@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital Allergy and Rheumatology |
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Name:
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Yukiko Iwasaki |
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Address:
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7-3-1 Hongou, Bunkyo-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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yunyan-todai@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital Allergy and Rheumatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Patients with pulmonary hypertension associated with left heart disease, chronic thromboembolic pulmonary hypertension, respiratory disease, and hypoxia 2)Patients with vasodilators (endothelin receptor antagonists, prostacyclin analogues and phosphodiesterase 5 inhibitors) started, or the dosage of the vasodilators changed within 4 weeks before the trial 3)Patients with malignancies or malignancy history within 5 years 4)Patients with sever liver diseases (AST(GOT) or ALT(GPT) over 100 U/L) 5)Patients with sever kidney diseases (serum creatinine over 3.0 mg/dL) 6)Patients with sever heart diseases 7)Patients with apparent active infectious diseases 8)Patients with hepatitis B virus carrier (patients with positive HBs antibody or HBc antibody should be monitored on their HBV-DNA monthly.(Exclude patients with history of HBV vaccination)) 9)Patients with history of serious infectious diseases
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Pulmonary arterial hypertension associated with connective tissue disease
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Intervention(s)
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Weekly rituximab (375mg/m2) infusion for 4 weeks
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Primary Outcome(s)
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Efficacy: Estimated right ventricular systolic pressure (echocardiography) and mean pulmonary arterial pressure (right heart catheterization) Safety: Adverse events and laboratory tests
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Source(s) of Monetary Support
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The University of Tokyo Hospital
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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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