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

NCT00718692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-01-30

No results posted yet for this study

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

DRUG

Sym001

Each cohort will receive one single dose of Sym001 according the assigned dose level.

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Symphogen A/S

    lead INDUSTRY

Principal Investigators

  • Mario Von Depka Prondzinski, PD Dr. · Werlhoff Institut Hannover, Germany

  • Ann Janssens, Dr. · ZU Gasthuisberg, Leuven, Belgium

  • Javier Loscertales Pueyo, Dra · Hospital La Princesa, Madrid, Spain

  • Wieslaw Wiktor Jedrzrjczak, Prof. · Katedra i klinika Hematologii, Warszawa, Poland

  • Andrei Cucucianu, Dr. · Prof. Dr. Ion Chiricuta Oncology Institute, Cluj-Napoca, Romania

  • Marie Scully, Prof. Dr. MD · University College London Hospitals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • United States
  • Belgium
  • Germany
  • India
  • Israel
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718692 on ClinicalTrials.gov