NCT00718692

Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)

A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Symphogen A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.

Conditions

• Immune Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	Sym001	Each cohort will receive one single dose of Sym001 according the assigned dose level.

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-08-01
• Completion: 2011-10-01
• First posted: 2008-07-21
• Last updated: 2019-01-30

Locations

59 sites across 12 countries: United States, Belgium, Germany, India, Israel, Poland, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom