Brand Name

Defitelio

Generic Name
Defibrotide
View Brand Information
FDA approval date: March 30, 2016
Form: Injection

What is Defitelio (Defibrotide)?

DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease , also known as sinusoidal obstruction syndrome , with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation . DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease , also known as sinusoidal obstruction syndrome , with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation .
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Related Clinical Trials

The Safety and Efficacy of Prophylactic Defibrotide Administration in Children, Adolescents, and Young Adults With Sickle Cell Disease or Beta Thalassemia Following Myeloablative Conditioning (MAC) and Haploidentical or Matched Unrelated Donor (MUD) Stem Cell Transplantation Utilizing CD34 Enrichment and T-Cell (CD3) Addback

Summary: This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and toxicity of administering Defibrotide prophylaxis for high-risk sickle cell or beta thalassemia patients undergoing a familial haploidentical or MUD allogeneic stem cell transplantation with CD34 enrichment and T-cell addback. This patient population historically has a risk of developing sinusoidal obstructive s...

A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19

Summary: The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.

A Phase II Intrapatient Open-Label Dose Escalation Trial of Defibrotide in Hematopoietic Cell Transplantation (HCT) Recipients With Sinusoidal Obstructive Syndrome (SOS) Post-HCT Associated With Either Renal and/or Pulmonary Dysfunction With Either Refractory or Progressive Disease Following Defibrotide Therapy

Summary: This research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) after hematopoietic cell transplantation (HCT) associated with either kidney and/or lung impairment that has not obtained a complete response (CR) or progressed in severity with standard doses o...