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Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study

Study:

Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study (Under CFR 312.34)

Rationale:

n/a

Purpose:

Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

Study Status: Recruiting

Recruiting:
n/a

Condition Intervention Phase
Hepatic Veno-Occlusive Disease Drug: Defibrotide
Drug: Defibrotide
Phase 3

Verified by Gentium SpA January, 2014

Sponsored by: Gentium SpA
Information provided by: Gentium SpA
ClinicalTrials.gov identifier: NCT00628498

Study Type: Interventional

Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Carin Heringa, M.D.., Study Director
Paul Richardson, M.D.., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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