UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000532 |
|---|---|
| Receipt number | R000000643 |
| Scientific Title | NPB-01(intravenous immunoglobulin)therapy for patients with pemphigus unresponsive to corticosteroids:Multi-center,Randomized,Double-Blind ,Placebo Control,Parallel Assignment Study to examine dose response and efficacy of NPB-01.(Phase2+3) |
| Date of disclosure of the study information | 2006/12/01 |
| Last modified on | 2009/05/27 13:29:46 |
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Basic information
Public title
NPB-01(intravenous immunoglobulin)therapy for patients with pemphigus unresponsive to corticosteroids:Multi-center,Randomized,Double-Blind ,Placebo Control,Parallel Assignment Study to examine dose response and efficacy of NPB-01.(Phase2+3)
Acronym
Dose response and efficacy confirmatory study of NPB-01 for patients with pemphigus unresponsive to corticosteroids.
Scientific Title
NPB-01(intravenous immunoglobulin)therapy for patients with pemphigus unresponsive to corticosteroids:Multi-center,Randomized,Double-Blind ,Placebo Control,Parallel Assignment Study to examine dose response and efficacy of NPB-01.(Phase2+3)
Scientific Title:Acronym
Dose response and efficacy confirmatory study of NPB-01 for patients with pemphigus unresponsive to corticosteroids.
Region
| Japan |
Condition
Condition
Pemphigus
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine dose response, efficacy and safety of NPB-01 for patients with pemphigus unresponsive to corticosteroids.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Days up to protocol-off
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0mg/kg per day for 5 days(placebo)
Interventions/Control_2
200mg/kg per day for 5 days
Interventions/Control_3
400mg/kg per day for 5 days
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with pemphigus unresponsive to corticosteroids
2)Patients with corticosteroids over 20mg/day
Key exclusion criteria
1)Patients treated with Plasmapheresis
2)Patients treated with corticosteroids pulse therapy (methylpredonizolone over 0.5g/day)
3)Patients received intravenous immunoglobulin
4) Patients with history of shock for NPB-01
5)Patients with history of Hypersensitivity for NPB-01
6)Patients with IgA deficiency
7)Patients with impaired liver function
8)Patients with impaired renal function
9)Patients with cerebro- or cardiovascular disorders or a history of these disorders
10)Patients with a high risk of thromboembolism
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Hashimoto |
Organization
Ehime University Hospital
Division name
Department of Dermatology
Zip code
Address
Shitsukawa,Toon,Ehime 791-0295,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | toshikazu okuno |
Organization
NIHON PHARMACEUTICAL CO.,LTD
Division name
Clinical Development Department
Zip code
Address
3-8,Dosho-machi 2-chome,chuo-ku,Osaka 541-0045,Japan
TEL
Homepage URL
Sponsor or person
Institute
NIHON PHARMACEUTICAL CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
NIHON PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 29 | Day |
Last modified on
| 2009 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000643
