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.
2 other identifiers
interventional
61
12 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2008
Typical duration for phase_2
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 18, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJanuary 30, 2019
January 1, 2019
3.1 years
July 18, 2008
January 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)
6 weeks post dosing
Secondary Outcomes (1)
Measurements of platelet counts
From day 1 through week 6
Study Arms (1)
1
EXPERIMENTALPatients treated with Sym001
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Symphogen A/Slead
- Swedish Orphan Biovitrumcollaborator
Study Sites (59)
Univ Nebraska Med Ctr. UNMC, 1005
Omaha, Nebraska, 68198-7680, United States
Hospital of the University of Pennsylvania, Site 1002
Philadelphia, Pennsylvania, 19104, United States
2085 Henry Tecklenburg Drive, 1001
Charleston, South Carolina, 29414, United States
Research Site 3203
Bruges, Belgium
Research Site 3202
Leuven, Belgium
Research Site 3201
Yvoir, Belgium
Research Site 4906, 4907
Berlin, Germany
Research Site 4902
Cologne, Germany
Research Site 4903
Duisburg, Germany
Research Site 4905
Essen, Germany
Reseach Site 4908
Halle, Germany
Research Site 4901
Hanover, Germany
Research Site 4904
Regensburg, Germany
St. John's Medical College Hospital, 9106
Bangalore, 560034, India
MS Ramaiah Memorial Hospital, 9108
Bangalore, 560054, India
Narayana Hrudayalaya Hospitals, 9105
Bangalore, 560099, India
Columbia Asia Referral Hospital-Yeshwanthpur, 9101
Bangalore, 576104, India
Aysha Hospital Pvt. Ltd., 9109
Chennai, 600010, India
Apollo Hospital, 9104
Hyderabad, 500033, India
Kasturba Medical College Hospital, 9103
Udupi, 576104, India
Bnai-Zion Medical Center, 9721
Haifa, 31048, Israel
Rambam Medical Center, 9723
Haifa, 35254, Israel
The Edith Wolfson Medical Center, 9725
Holon, 58100, Israel
Western Galilee - Nahariya Hospital, 9722
Nahariya, 22100, Israel
Rabin Medical Center, 9724
Petah Tikva, 49100, Israel
Tel-Aviv Sourasky Medical Center, 9726
Tel Aviv, 64239, Israel
Research site 4801
Gdansk, Poland
Research Site 4806
Krakow, Poland
Research Site 4805
Lodz, Poland
Instytut Hematologii i Transfuzjologii, 4807
Warsaw, Poland
Research Site 4802, 4808
Warsaw, Poland
Research Site 4803
Warszava, Poland
Research Site 4804
Wroclaw, Poland
Brasov Country Hospital, 4002
Brasov, Romania
Institutul Clinic Fundeni, 4003
Bucharest, Romania
"Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001
Cluj-Napoca, Romania
Spitalul Clinic de Urgente Sfantu Spiridon, 4004
Iași, Romania
Regional Clinical Hospital of Nizhny Novgorod, 7003
Nizhny Novgorod, 603126, Russia
Saint Petersburg State Institution Of Healthcare, 7001
Saint Petersburg, 198205, Russia
Regional Clinical Hospital na MI Kalinin, 7005
Samara, 443095, Russia
State Healthcare Institution Tula Regional Clin. Hosp., 7002
Tula, 300053, Russia
Clinical Center Nis 3802
Niš, 18000, Serbia
Clinical center Vojvodina 3801
Novi Sad, 2100, Serbia
Clinical Center Zemun 3803
Zemun, 11080, Serbia
Reseach Site 3403
Barcelona, Spain
Hospital Gregorio Maranon, 3405
Madrid, Spain
Hospital La Princesa, 3404
Madrid, Spain
Research Site 3401
Madrid, Spain
Research Site 3402
Valencia, Spain
Cherkassy regional oncology center, 3906
Cherkassy, 180009, Ukraine
Gusak Academy of AMS Ukraine, 3905
Donetsk, 83045, Ukraine
Khmelnytskyi Regional Hospital, 3903
Khmelnytskyi, 29000, Ukraine
City Hospital #9 Kyiv Clinical Hospital, 3904
Kiev, 04112, Ukraine
Vinnytsya Regional Clinical Hospital, 3902
Vinnytsia, 21018, Ukraine
St. James's University Hospital, 4403
Leeds, LS9 7TF, United Kingdom
Hammersmith Hosptial, 4402
London, W12 OHS, United Kingdom
University College, 4401
London, WC1E 6HX, United Kingdom
Royal Victoria Infirmery, 4404
Newcastle upon Tyne, NE1 4LP, United Kingdom
Singleton Hospital, 4405
Swansea, SA2 8QL, United Kingdom
Related Publications (1)
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.
PMID: 22915649RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2008
First Posted
July 21, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2011
Study Completion
October 1, 2011
Last Updated
January 30, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share