Trial | NCT00718692  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    61
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.
Study Started
Jul 31
2008
Primary Completion
Aug 31
2011
Study Completion
Oct 31
2011
Last Update
Jan 30
2019

Drug Sym001

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

1 Experimental

Patients treated with Sym001

Criteria 

Inclusion Criteria:

Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the pre-dose visit.
History of isolated ITP
RhD-positive serology.
Previous treatment and response to first line therapy for ITP

Exclusion Criteria:

Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.
Suspected infection with HIV, Hepatitis C, H. pylori.
Clinical splenomegaly
History of abnormal bone marrow examination.
Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.
Underlying haemolytic condition
History of splenectomy.
Subject is pregnant, breast feeding or intends to become pregnant.
No Results Posted