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

NCT ID: NCT00718692

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Immune Thrombocytopenic Purpura

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients treated with Sym001

Group Type EXPERIMENTAL

Sym001

Intervention Type DRUG

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

Interventions

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Sym001

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role collaborator

Symphogen A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mario Von Depka Prondzinski, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Werlhoff Institut Hannover, Germany

Ann Janssens, Dr.

Role: PRINCIPAL_INVESTIGATOR

ZU Gasthuisberg, Leuven, Belgium

Javier Loscertales Pueyo, Dra

Role: PRINCIPAL_INVESTIGATOR

Hospital La Princesa, Madrid, Spain

Wieslaw Wiktor Jedrzrjczak, Prof.

Role: PRINCIPAL_INVESTIGATOR

Katedra i klinika Hematologii, Warszawa, Poland

Andrei Cucucianu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Prof. Dr. Ion Chiricuta Oncology Institute, Cluj-Napoca, Romania

Marie Scully, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals

Locations

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Univ Nebraska Med Ctr. UNMC, 1005

Omaha, Nebraska, United States

Site Status

Hospital of the University of Pennsylvania, Site 1002

Philadelphia, Pennsylvania, United States

Site Status

2085 Henry Tecklenburg Drive, 1001

Charleston, South Carolina, United States

Site Status

Research Site 3203

Bruges, , Belgium

Site Status

Research Site 3202

Leuven, , Belgium

Site Status

Research Site 3201

Yvoir, , Belgium

Site Status

Research Site 4906, 4907

Berlin, , Germany

Site Status

Research Site 4902

Cologne, , Germany

Site Status

Research Site 4903

Duisburg, , Germany

Site Status

Research Site 4905

Essen, , Germany

Site Status

Reseach Site 4908

Halle, , Germany

Site Status

Research Site 4901

Hanover, , Germany

Site Status

Research Site 4904

Regensburg, , Germany

Site Status

St. John's Medical College Hospital, 9106

Bangalore, , India

Site Status

MS Ramaiah Memorial Hospital, 9108

Bangalore, , India

Site Status

Narayana Hrudayalaya Hospitals, 9105

Bangalore, , India

Site Status

Columbia Asia Referral Hospital-Yeshwanthpur, 9101

Bangalore, , India

Site Status

Aysha Hospital Pvt. Ltd., 9109

Chennai, , India

Site Status

Apollo Hospital, 9104

Hyderabad, , India

Site Status

Kasturba Medical College Hospital, 9103

Udupi, , India

Site Status

Bnai-Zion Medical Center, 9721

Haifa, , Israel

Site Status

Rambam Medical Center, 9723

Haifa, , Israel

Site Status

The Edith Wolfson Medical Center, 9725

Holon, , Israel

Site Status

Western Galilee - Nahariya Hospital, 9722

Nahariya, , Israel

Site Status

Rabin Medical Center, 9724

Petah Tikva, , Israel

Site Status

Tel-Aviv Sourasky Medical Center, 9726

Tel Aviv, , Israel

Site Status

Research site 4801

Gdansk, , Poland

Site Status

Research Site 4806

Krakow, , Poland

Site Status

Research Site 4805

Lodz, , Poland

Site Status

Instytut Hematologii i Transfuzjologii, 4807

Warsaw, , Poland

Site Status

Research Site 4802, 4808

Warsaw, , Poland

Site Status

Research Site 4803

Warszava, , Poland

Site Status

Research Site 4804

Wroclaw, , Poland

Site Status

Brasov Country Hospital, 4002

Brasov, , Romania

Site Status

Institutul Clinic Fundeni, 4003

Bucharest, , Romania

Site Status

"Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001

Cluj-Napoca, , Romania

Site Status

Spitalul Clinic de Urgente Sfantu Spiridon, 4004

Iași, , Romania

Site Status

Regional Clinical Hospital of Nizhny Novgorod, 7003

Nizhny Novgorod, , Russia

Site Status

Saint Petersburg State Institution Of Healthcare, 7001

Saint Petersburg, , Russia

Site Status

Regional Clinical Hospital na MI Kalinin, 7005

Samara, , Russia

Site Status

State Healthcare Institution Tula Regional Clin. Hosp., 7002

Tula, , Russia

Site Status

Clinical Center Nis 3802

Niš, , Serbia

Site Status

Clinical center Vojvodina 3801

Novi Sad, , Serbia

Site Status

Clinical Center Zemun 3803

Zemun, , Serbia

Site Status

Reseach Site 3403

Barcelona, , Spain

Site Status

Hospital Gregorio Maranon, 3405

Madrid, , Spain

Site Status

Hospital La Princesa, 3404

Madrid, , Spain

Site Status

Research Site 3401

Madrid, , Spain

Site Status

Research Site 3402

Valencia, , Spain

Site Status

Cherkassy regional oncology center, 3906

Cherkassy, , Ukraine

Site Status

Gusak Academy of AMS Ukraine, 3905

Donetsk, , Ukraine

Site Status

Khmelnytskyi Regional Hospital, 3903

Khmelnytskyi, , Ukraine

Site Status

City Hospital #9 Kyiv Clinical Hospital, 3904

Kiev, , Ukraine

Site Status

Vinnytsya Regional Clinical Hospital, 3902

Vinnytsia, , Ukraine

Site Status

St. James's University Hospital, 4403

Leeds, , United Kingdom

Site Status

Hammersmith Hosptial, 4402

London, , United Kingdom

Site Status

University College, 4401

London, , United Kingdom

Site Status

Royal Victoria Infirmery, 4404

Newcastle upon Tyne, , United Kingdom

Site Status

Singleton Hospital, 4405

Swansea, , United Kingdom

Site Status

Countries

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

References

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Robak T, Windyga J, Trelinski J, von Depka Prondzinski M, Giagounidis A, Doyen C, Janssens A, Alvarez-Roman MT, Jarque I, Loscertales J, Rus GP, Hellmann A, Jedrzejczak WW, Kuliczkowski K, Golubovic LM, Celeketic D, Cucuianu A, Gheorghita E, Lazaroiu M, Shpilberg O, Attias D, Karyagina E, Svetlana K, Vilchevska K, Cooper N, Talks K, Prabhu M, Sripada P, Bharadwaj TP, Naested H, Skartved NJ, Frandsen TP, Flensburg MF, Andersen PS, Petersen J. Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia. Blood. 2012 Nov 1;120(18):3670-6. doi: 10.1182/blood-2012-06-438804. Epub 2012 Aug 20.

Reference Type RESULT
PMID: 22915649 (View on PubMed)

Other Identifiers

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2007-006081-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Sym001-03

Identifier Type: -

Identifier Source: org_study_id

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