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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-UMIN000018660 |
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Date of registration:
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17/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Japanese POEMS syndrome with thalidmaide trial for compassionate use
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Scientific title:
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Japanese POEMS syndrome with thalidmaide trial for compassionate use - Japanese POEMS syndrome with thalidmaide trial for compassionate use (JPOST15) |
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Date of first enrolment:
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2015/08/17 |
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Target sample size:
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20 |
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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=R000021237 |
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Study type:
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Interventional |
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Study design:
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expanded access 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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Satoshi
Kuwabara |
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Address:
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Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
Japan |
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Telephone:
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0432227171 |
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Email:
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syukari536@chiba-u.jp |
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Affiliation:
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Chiba University, Graduate School of Medicine Department of Neurology |
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Name:
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Kanako
Katayama |
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Address:
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Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
2608677
Japan |
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Telephone:
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0432227171 |
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Email:
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katayama-k@umin.net |
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Affiliation:
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Chiba University Hospital Clinical research center |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1) Patients with the complication which leading to a high risk of severe adversed event by thalidomide (Absolute neutrophil count < 1000, Platelet count< 50000, repeated ileus,severe cardiac arrhythmias) (2) Female patients who are pregnant, desire childbearing or breastfeeding (3) Males patients who desire fertility. (4) Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes) (5) Patients who allergic to thalidomide (6) Patients with severe phychiatric disorders (7) Patients who has been participated any other clinical trial (8)Patients who are not appropriate to participate to the trial
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Crow-Fukase(POEMS) syndrome
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Intervention(s)
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FPF300 (thalidomide)100-300mg/day,at bedtime +Dexamethasone 20mg/day (day1-4) Duration:until the approval of thalidomide for POEMT syndrome
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Primary Outcome(s)
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Safety:Adverse event during FPF300 treatment Efficacy:Overall survival
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Secondary Outcome(s)
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1.Serum VEGF level 2.Motor function(Manual Muscle Test, grip strength,ONLS) 3.Median nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency, SNAP amplitudes), Sural nerve conduction study (SNAP amlitudes and conduction velocity) 4.M protein (immunofixation) 5. Pleural effusion 6. Body weight
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Source(s) of Monetary Support
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Chiba university hospital
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Ethics review
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Status: YES
Approval date: 22/07/2015
Contact:
yamazaki@office.chiba-u.jp
Clinical research center, Chiba university hospital
0432227171
yamazaki@office.chiba-u.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/04/2020 |
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URL:
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