Study of Veltuzumab (hA20) at Different Doses in Patients With ITP

Stopped early · Phase 1/Phase 2

Conditions studied: Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Autoimmune

In brief

This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.

Key facts

Study ID

NCT00547066

Run by

Gilead Sciences

People needed

48

Starts

2007-11-01

Expected to finish

2011-11-01

Last updated by the study team

2021-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, >18 years old, with or without prior splenectomy
• Signed written informed consent obtained prior to study entry
• ITP according to ASH guidelines, with other potential causes of thrombocytopenia excluded
• Platelet levels < 150 x 109/L for more than 6 months
• Received an adequate course of at least one standard ITP treatment (an inadequate course of standard ITP therapy does not qualify as meeting this requirement)
• Platelet count < 30 x 109/L at study entry and on at least one other occasion at least 1 week apart within the past month. (Phase I only: platelet count also > 10 x 109/L at study entry).
• Bleeding assessment score of Grade 0 or 1. See full protocol for all inclusion criteria

You may not qualify if…

• See full protocol for exclusion criteria or contact study staff for details

Where it is running

• University of Southern California- Keck School of Medicine — Los Angeles, California, United States
• Center of Hope for Cancer and Blood Disorders — Riverdale, Georgia, United States
• Georgia Cancer Specialtists — Tucker, Georgia, United States
• Goshen Center for Cancer Care — Goshen, Indiana, United States
• Hematology Oncology Specialists — Metairie, Louisiana, United States
• Study site — Denville, New Jersey, United States
• Hematology/Oncology Specialists — Buffalo, New York, United States
• New York Presbyterian Hospital Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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