UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047418 |
|---|---|
| Receipt number | R000054069 |
| Scientific Title | The clinical impact of immunoglobulin replacement therapy on severe bacterial infection for patients with hypogammaglobulinemia secondary to hematologic malignancies: A Japanese claims database study |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2023/04/06 13:48:33 |
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Basic information
Public title
The clinical impact of immunoglobulin replacement therapy on severe bacterial infection for patients with hypogammaglobulinemia secondary to hematologic malignancies: A Japanese claims database study
Acronym
A database study on immunoglobulin replacement therapy in patients with secondary hypogammaglobulinemia
Scientific Title
The clinical impact of immunoglobulin replacement therapy on severe bacterial infection for patients with hypogammaglobulinemia secondary to hematologic malignancies: A Japanese claims database study
Scientific Title:Acronym
A database study on immunoglobulin replacement therapy in patients with secondary hypogammaglobulinemia
Region
| Japan |
Condition
Condition
hypogammaglobulinemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether IgRT decreases the risk of a severe bacterial infection or infectious event (SBI) in patients with hypogammaglobulinemia secondary to hematologic malignancies.
Basic objectives2
Others
Basic objectives -Others
The primary objective of this study is to investigate the clinical impact of IgRT on SBI in patients diagnosed with hypogammaglobulinemia secondary to hematologic malignancies.
Secondary objectives are to investigate the clinical impact of IgRT on SBI in subgroups of patients diagnosed with hypogammaglobulinemia due to hematologic malignancies and stratified by cancer type and medication or procedure.
We also plan to conduct exploratory analyses to elucidate the real-world clinical situation and outcomes of IgRT in patients with secondary hypogammaglobulinemia in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of SBIs per person-year in the 12 months after the index date, which is defined as the date of initiation of IgRT, will be compared with that in the 12 months before the index date in patients on an adequate dosage of IgRT.
Key secondary outcomes
(1) The number of days of administration of intravenous antibiotics during hospitalization in the 12 months after the index date will be compared with that in the 12 months before the index date in patients on an adequate dosage of IgRT.
(2) The incidence rate of SBIs per person-year in the 3 months after the index date will be compared with that in the 3 months before the index date in patients on an adequate dosage of IgRT.
(3) The incidence rate of SBIs per person-year during the period from the initiation of anti-cancer drugs until the index date will be compared with that during the period of administration of IgRT in patients on an adequate dosage of IgRT, without any experience of HSCT.
(4) Subgroup analysis of the primary endpoint by the type of hematologic malignancy (i.e., CLL, NHL, MM), the type of B-cell targeted agents received, and whether or not HSCT was performed before the index date in patients on an adequate dosage of IgRT.
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosed with hematologic malignancies (ICD-10 codes: C81x-96x) during the study period (from May 2010 to March 2021).
(2) Diagnosed with hypogammaglobulinemia (disease code: 2790006) during the study period.
(3) Received immunoglobulins (IVIGs and SCIG [drug codes: J06C0 and J06E0, respectively]) after both the first diagnosis date of hematologic malignancy and that of hypogammaglobulinemia.
The first prescription date after the first diagnosis date of hypogammaglobulinemia will be defined as the index date.
(4) Have 2 or more medical records in the 12 months before the index date (baseline period).
(5) Have 2 or more medical records in the subsequent 12 months after the index date (follow-up period).
(6) Received 2 or more courses of immunoglobulins (drug codes: J06C0 and J06E0) during the follow-up period.
One course will be defined as a continuous prescription period with an interval of less than 7 days.
(7) Aged >= 16 years at the index date.
Key exclusion criteria
(1) Diagnosed with immunodeficiency (primary immunodeficiency [PID; disease code: 2793012] or human immunodeficiency virus [HIV; ICD-10 code: B20x-B24x]) during the study period.
(2) Diagnosed with any other diseases* for which immunoglobulins can be used according to regulations in Japan (ICD-10 code: D693, G360, G610, G618, G700, H46x, L10x, L12x, L511, L512, M301, M303, M33x) during the study period.
(3) Have a record of immunoglobulin treatment before the initial diagnosis of hypogammaglobulinemia.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Uenishi |
Organization
Medilead Inc.
Division name
Data Science Dept.
Zip code
163-1424
Address
Tokyo Opera City Tower, 3-20-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-1424 JAPAN
TEL
03-6859-2295
t_uenishi@medi-l.com
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Shoji |
Organization
Medilead Inc.
Division name
Data Science Dept.
Zip code
163-1424
Address
Tokyo Opera City Tower, 3-20-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-1424 JAPAN
TEL
03-6859-2295
Homepage URL
a_shoji@medi-l.com
Sponsor or person
Institute
CSL Behring K.K.
Institute
Department
Personal name
Funding Source
Organization
CSL Behring K.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
non-profit organization MINS
Address
5-20-9-401, Mita, Minato, Tokyo, Japan
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 | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective non-interventional study that will use quality-controlled data from an existing database and will not conduct primary data collection.
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054069
