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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00718692
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : January 30, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
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.
Actual Study Start Date : July 2008
Actual Primary Completion Date : August 2011
Actual 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 identifier (NCT number): NCT00718692

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Sponsors and Collaborators
Symphogen A/S
Swedish Orphan Biovitrum
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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 Hospitals
Publications of Results:
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Responsible Party: Symphogen A/S Identifier: NCT00718692    
Other Study ID Numbers: Sym001-03
2007-006081-15 ( EudraCT Number )
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Symphogen A/S:
Additional relevant MeSH terms:
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Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases