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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000532
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute NIHON PHARMACEUTICAL CO.,LTD
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000643

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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