UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048078 |
|---|---|
| Receipt number | 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 | 2023/04/05 14:31:35 |
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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
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
takashi.sato3@iqvia.com
Sponsor or person
Institute
Alexion Pharma G.K.
Institute
Department
Personal name
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
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
Terminated
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
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054799
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
