UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054325 |
|---|---|
| Receipt number | R000061958 |
| Scientific Title | Drug Use-Results Survey of PIASKY for Injection 340mg (All-Patient Surveillance) -Paroxysmal nocturnal hemoglobinuria- |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2024/05/07 10:30:23 |
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Basic information
Public title
Drug Use-Results Survey of PIASKY for Injection 340mg (All-Patient Surveillance) -Paroxysmal nocturnal hemoglobinuria-
Acronym
Drug Use-Results Survey of PIASKY for Injection 340mg (All-Patient Surveillance) -Paroxysmal nocturnal hemoglobinuria-
Scientific Title
Drug Use-Results Survey of PIASKY for Injection 340mg (All-Patient Surveillance) -Paroxysmal nocturnal hemoglobinuria-
Scientific Title:Acronym
Drug Use-Results Survey of PIASKY for Injection 340mg (All-Patient Surveillance) -Paroxysmal nocturnal hemoglobinuria-
Region
| Japan |
Condition
Condition
Paroxysmal nocturnal hemoglobinuria
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to calculate the incidence of Transient Immune Complex Reactions during clinical use of PIASKY in patients with paroxysmal nocturnal hemoglobinuria.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of adverse drug reactions
Changes in LDH and CH50 from baseline
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
Patients eligible for enrollment: all patients expected to receive the drug during the enrollment period
Patients eligible for case report form (CRF) collection: all patients eligible for enrollment who receive the drug
Data will be collected retrospectively from patients who receive the drug before conclusion of the agreement for this surveillance study, and CRFs will be collected for all patients who receive the drug.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takemoto |
Organization
Chugai Pharmaceutical Co. Ltd
Division name
Safety Science 2 Department
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
takemotosny@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Murayama |
Organization
Chugai Pharmaceutical Co. Ltd
Division name
Safety Science 2 Department
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
murayamaayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai 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
None
Address
None
Tel
None
None
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
| 2024 | Year | 05 | Month | 07 | 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
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation period per case is set to 52 weeks after the start of administration. Survey forms are entered at the 12-week and 52-week points after the start of administration. However, in cases where the administration of this drug is discontinued, observation continues for 8 weeks from the point of discontinuation, and if switched to another anti-C5 antibody preparation within 8 weeks from the point of discontinuation, observation continues for an additional 12 weeks from the day of the switch to the other anti-C5 antibody preparation.
Management information
Registered date
| 2024 | Year | 05 | Month | 07 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061958
