G-CSF Treatment for Agranulocytosis Induced by Antithyroid Drugs: Multicenter randomized controlled trial

G-CSF Treatment for Agranulocytosis Induced by Antithyroid Drugs: A multicenter randomized controlled trial - RADIANT-PEG trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056357

Enrollment

Registered

2024-12-07

Start date

2024-12-07

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study involves male and female patients (aged 18 or older) with agranulocytosis caused by antithyroid drugs who present with symptoms, a body temperature &gt

Interventions

Placebo group: subcutaneous injection of saline is administered daily until the neutrophil count reaches &gt

= 1500/uL. The group also receive intravenous TAZ/PIPC (4.5 g, 4 times daily) from the time of hospitalization. Filgrastim group: subcutaneous injection of filgrastim 300 ug is administered daily u

= 1500/uL. The group also receive intravenous TAZ/PIPC (4.5 g, 4 times daily) from the time of hospitalization. Pegfilgrastim group: pegfilgrastim is administered only on the first day, followed by d

= 1500/uL. The group also receive intravenous TAZ/PIPC (4.5 g, 4 times daily) from the time of hospitalization

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Participation in other clinical trials Pregnancy Mental illness Deemed ineligible by the attending physician

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Japan

Contacts

Public ContactTetsuya Kawahara

Shinkomonji Hospital Endocrinology and Metabolism

k-tetsuy@med.uoeh-u.ac.jp0933911001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026