UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056357 |
|---|---|
| Receipt number | R000064392 |
| Scientific Title | G-CSF Treatment for Agranulocytosis Induced by Antithyroid Drugs |
| Date of disclosure of the study information | 2024/12/07 |
| Last modified on | 2025/10/18 19:03:45 |
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Basic information
Public title
G-CSF Treatment for Agranulocytosis Induced by Antithyroid Drugs
Acronym
G-CSF Treatment for Agranulocytosis
Scientific Title
G-CSF Treatment for Agranulocytosis Induced by Antithyroid Drugs
Scientific Title:Acronym
G-CSF Treatment for Agranulocytosis
Region
| Japan |
Condition
Condition
This study involves male and female patients (aged 18 or older) with agranulocytosis caused by antithyroid drugs who present with symptoms, a body temperature >=37.5 degrees, and a neutrophil count < 500/uL.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Hematology and clinical oncology |
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The incidence of agranulocytosis caused by antithyroid drugs for Graves' disease is relatively low, at 0.2 to 0.5%. However, once it occurs, there is a high risk of severe infections and complications.
For patients with agranulocytosis induced by antithyroid drugs:
If asymptomatic with neutrophil count <100/uL, low-dose G-CSF is administered.
Regardless of symptoms, high-dose G-CSF is recommended if the neutrophil count is <100/uL. This recommendation is based on observational studies and has a low evidence level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Number of days until all of the following criteria are met: neutrophil count >=1500/uL, body temperature <37.5 degree, CRP <3.0 mg/dL, and procalcitonin <0.5 ng/mL or a reduction of >= 80% from the peak value.
Key secondary outcomes
Days required for neutrophil count normalization (>= 1500/uL).
Days required for infection resolution (disappearance of symptoms, body temperature <37.5 degrees, CRP <3.0 mg/dL, and procalcitonin <0.5 ng/mL or a reduction of >= 80% from the peak value).
Days required for neutrophil count normalization (neutrophil count >=1500/uL) and infection resolution (body temperature <37.5 degrees, CRP <3.0 mg/dL, and procalcitonin <0.5 ng/mL or a reduction of >=80% from the peak value) among patients with baseline neutrophil count of < 100/uL).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo group: subcutaneous injection of saline is administered daily until the neutrophil count reaches >= 1500/uL.
The group also receive intravenous TAZ/PIPC (4.5 g, 4 times daily) from the time of hospitalization.
Interventions/Control_2
Filgrastim group: subcutaneous injection of filgrastim 300 ug is administered daily until the neutrophil count reaches >= 1500/uL.
The group also receive intravenous TAZ/PIPC (4.5 g, 4 times daily) from the time of hospitalization.
Interventions/Control_3
Pegfilgrastim group: pegfilgrastim is administered only on the first day, followed by daily subcutaneous injections of placebo thereafter until the neutrophil count reaches >= 1500/uL.
The group also receive intravenous TAZ/PIPC (4.5 g, 4 times daily) from the time of hospitalization
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study involves patients with agranulocytosis caused by antithyroid drugs who present with symptoms, a body temperature >=37.5 degrees, and a neutrophil count < 500/uL.
Key exclusion criteria
Participation in other clinical trials
Pregnancy
Mental illness
Deemed ineligible by the attending physician
Target sample size
81
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shinkomonji Hospital
Division name
Endocrinology and Metabolism
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu
TEL
093-391-1001
k-tetsuy@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shinkomonji Hospital
Division name
Endocrinology and Metabolism
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu
TEL
0933911001
Homepage URL
https://www.shinkomonji-hp.jp/
k-tetsuy@med.uoeh-u.ac.jp
Sponsor or person
Institute
Shinkomonji Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Medical Association
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinkomonji Hospital
Address
2-5 Dairishinmachi, Moji, Kitakyushu
Tel
0933911001
k-tetsuy@med.uoeh-u.ac.jp
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
新小文字病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064392
