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

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ClinicalTrials.gov Identifier: NCT00718692
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : February 15, 2018
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Symphogen A/S

Brief 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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Drug: Sym001 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : July 2008
Primary Completion Date : August 2011
Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: 1
Patients treated with Sym001
Drug: Sym001
Each cohort will receive one single dose of Sym001 according the assigned dose level.

Primary Outcome Measures :
  1. Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) [ Time Frame: 6 weeks post dosing ]

Secondary Outcome Measures :
  1. Measurements of platelet counts [ Time Frame: From day 1 through week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718692

  Show 59 Study Locations
Sponsors and Collaborators
Symphogen A/S
Swedish Orphan Biovitrum
Principal Investigator: Mario Von Depka Prondzinski, PD Dr. Werlhoff Institut Hannover, Germany
Principal Investigator: Ann Janssens, Dr. ZU Gasthuisberg, Leuven, Belgium
Principal Investigator: Javier Loscertales Pueyo, Dra Hospital La Princesa, Madrid, Spain
Principal Investigator: Wieslaw Wiktor Jedrzrjczak, Prof. Katedra i klinika Hematologii, Warszawa, Poland
Principal Investigator: Andrei Cucucianu, Dr. Prof. Dr. Ion Chiricuta Oncology Institute, Cluj-Napoca, Romania
Principal Investigator: Marie Scully, Prof. Dr. MD University College London, UK.

Responsible Party: Symphogen A/S
ClinicalTrials.gov Identifier: NCT00718692     History of Changes
Other Study ID Numbers: Sym001-03
2007-006081-15 ( EudraCT Number )
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Symphogen A/S:

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases