Skip to main content
OpenTrials
Completed

NCT Number: NCT00718692

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immune Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site 3203, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sym001

Drug

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

Primary outcomes

  1. Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)

    Time frame: 6 weeks post dosing

Secondary outcomes

  1. Measurements of platelet counts

    Time frame: From day 1 through week 6

Sponsors and collaborators

Lead sponsor

Symphogen A/S

Industry

Collaborators

  • Swedish Orphan Biovitrum

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 21, 2008
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.