Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes

Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes - Immunomodulatory therapy using ATG/PeG-CSF for recently onset type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027070

Enrollment

Registered

2017-04-21

Start date

2017-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 1 diabetes

Interventions

Anti-thymocyte globulin: 0.5 mg/kg (Day 1), 1.5 mg/kg (Day 2) Pegfilgrastim: 3.6 mg x 6 times every 2 weeks (starting at Day 3)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acute-onset type 1 diabetes 2. Within 12 months since diagnosis 3. Fasting serum C-peptide > 0.3 ng/mL

Exclusion criteria

Exclusion criteria: 1. Active infection 2. Pregnancy/breast-feeding 3. Past history of malignant tumor 4. Interstitial pneumonia 5. Severe liver or/and kidney dysfunction 6. Past history of ATG administration 7. Under systemic steroid therapy

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events during 52 weeks of the treatment or observation	—

Countries

Japan

Contacts

Public ContactDaisuke Chujo

Toyama University Hospital Center for Clinical Research

dchujo@med.u-toyama.ac.jp076-434-2281

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026