NCT03790332

Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib capsule, tablet, or suspension administered orally once daily

Timeline

• Start date: 2018-11-19
• Primary completion: 2025-10-09
• Completion: 2025-10-09
• First posted: 2018-12-31
• Last updated: 2025-10-21

Locations

48 sites across 13 countries: United States, Australia, Austria, Canada, France, Germany, Israel, Italy, Netherlands, Russia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study