NCT03339297

An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

Conditions

• Graft-versus-host Disease
• Acute-graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Defibrotide	6.25 mg/kg via 2-hour IV infusion every 6 hours
DRUG	Standard of Care	Administered according to local institutional guidelines, physician preference, and patient need.

Timeline

• Start date: 2018-02-21
• Primary completion: 2020-05-12
• Completion: 2020-05-12
• First posted: 2017-11-13
• Last updated: 2021-08-18
• Results posted: 2021-08-18

Locations

62 sites across 14 countries: United States, Austria, Belgium, Bulgaria, Canada, Croatia, France, Germany, Greece, Italy, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study