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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048078
Receipt No. R000054799
Scientific Title Long-term impact of eculizumab on quality of life and patient-reported symptoms of Japanese GBS patients at 52 weeks post disease onset: an observational survey
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/16

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Basic information
Public title Long-term impact of eculizumab on quality of life and patient-reported symptoms of Japanese GBS patients at 52 weeks post disease onset: an observational survey
Acronym ECU-GBS-LTO study
Scientific Title Long-term impact of eculizumab on quality of life and patient-reported symptoms of Japanese GBS patients at 52 weeks post disease onset: an observational survey
Scientific Title:Acronym ECU-GBS-LTO study
Region
Japan

Condition
Condition Guillain-Barre syndrome
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the long-term impact of eculizumab+IVIg and IVIg alone on PROs and HR-QoL of Japanese GBS patients at one year (52 [+/-12]weeks) after randomization in the parent ECU-GBS-301 trial (hereafter referred to "GBS onset").
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Inflammatory Rasch-Built Overall Disability Scale (I-RODS)
Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)
DASS: Depression Anxiety Stress Scale (DASS-21)
EuroQoL- 5 Dimension 5 Level (EQ-5D-5L)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with GBS enrolled in the parent ECU-GBS-301 trial who have completed the 4 times study drug treatment schedule in the parent trial and who have two measures of the PRO (one at baseline and at least one post-baseline)
2.Discontinuers of the parent ECU-GBS-301 trial meeting the inclusion/exclusion criteria maybe included
3.Patients who signed and dated the informed consent document indicating that they have been informed of all important aspects of the study
Key exclusion criteria Patients who are unable to answer the study questionnaires and who do not have any next of kin or caregiver available to answer the study questionnaire on their behalf
Target sample size 99

Research contact person
Name of lead principal investigator
1st name Hirokazu
Middle name
Last name Ishida
Organization Alexion Pharma G.K.
Division name Research & Development Division
Zip code 108-0023
Address Tamachi Station Tower N, 3-1-1 Shibaura, Minato-ku, Tokyo Japan
TEL 03-3457-9559
Email hirokazu.ishida@alexion.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Sato
Organization IQVIA Services Japan K.K.
Division name Real-World Evidence Services
Zip code 108-0074
Address Keikyu Dai-ichi bldg. 4-10-18 Takanawa, Minato-ku, Tokyo Japan
TEL 03-6859-9500
Homepage URL
Email takashi.sato3@iqvia.com

Sponsor
Institute Alexion Pharma G.K.
Institute
Department

Funding Source
Organization Alexion Pharma G.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NPO MINS
Address ST Shibuya bldg. 2nd floor, 1-15-14 Dougenzaka, Shibuya-ku, Tokyo
Tel 03-6416-1868
Email npo-mins@j-irb.com

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
2022 Year 06 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 23 Day
Date of IRB
2022 Year 06 Month 02 Day
Anticipated trial start date
2022 Year 07 Month 02 Day
Last follow-up date
2023 Year 05 Month 31 Day
Date of closure to data entry
2023 Year 06 Month 30 Day
Date trial data considered complete
2023 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information to evaluate the long-term impact of eculizumab+IVIg and IVIg alone on PROs and HR-QoL of Japanese GBS patients at one year (52 [+/- 12] weeks) after randomization in the parent ECU-GBS-301 trial

Management information
Registered date
2022 Year 06 Month 16 Day
Last modified on
2022 Year 06 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054799

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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