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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00718692
Other study ID # Sym001-03
Secondary ID 2007-006081-15
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2008
Est. completion date October 2011

Study information

Verified date January 2019
Source Symphogen A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Research Site 3203 Brugge
Belgium Research Site 3202 Leuven
Belgium Research Site 3201 Yvoir
Germany Research Site 4906, 4907 Berlin
Germany Research Site 4903 Duisburg
Germany Research Site 4905 Essen
Germany Reseach Site 4908 Halle
Germany Research Site 4901 Hannover
Germany Research Site 4902 Köln
Germany Research Site 4904 Regensburg
India Columbia Asia Referral Hospital-Yeshwanthpur, 9101 Bangalore
India MS Ramaiah Memorial Hospital, 9108 Bangalore
India Narayana Hrudayalaya Hospitals, 9105 Bangalore
India St. John's Medical College Hospital, 9106 Bangalore
India Aysha Hospital Pvt. Ltd., 9109 Chennai
India Apollo Hospital, 9104 Hyderabad
India Kasturba Medical College Hospital, 9103 Udupi
Israel Bnai-Zion Medical Center, 9721 Haifa
Israel Rambam Medical Center, 9723 Haifa
Israel The Edith Wolfson Medical Center, 9725 Holon
Israel Western Galilee - Nahariya Hospital, 9722 Nahariya
Israel Rabin Medical Center, 9724 Petach Tikva
Israel Tel-Aviv Sourasky Medical Center, 9726 Tel Aviv
Poland Research site 4801 Gdansk
Poland Research Site 4806 Krakow
Poland Research Site 4805 Lodz
Poland Research Site 4803 Warszava
Poland Instytut Hematologii i Transfuzjologii, 4807 Warszawa
Poland Research Site 4802, 4808 Warszawa
Poland Research Site 4804 Wroclaw
Romania Brasov Country Hospital, 4002 Brasov
Romania Institutul Clinic Fundeni, 4003 Bucuresti
Romania "Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001 Cluj-Napoca
Romania Spitalul Clinic de Urgente Sfantu Spiridon, 4004 Iasi
Russian Federation Regional Clinical Hospital of Nizhny Novgorod, 7003 Nizhny Novgorod
Russian Federation Regional Clinical Hospital na MI Kalinin, 7005 Samara
Russian Federation Saint Petersburg State Institution Of Healthcare, 7001 St. Petersburg
Russian Federation State Healthcare Institution Tula Regional Clin. Hosp., 7002 Tula
Serbia Clinical Center Nis 3802 Nis
Serbia Clinical center Vojvodina 3801 Novi Sad
Serbia Clinical Center Zemun 3803 Zemun
Spain 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
Ukraine Cherkassy regional oncology center, 3906 Cherkassy
Ukraine Gusak Academy of AMS Ukraine, 3905 Donetsk
Ukraine Khmelnytskyi Regional Hospital, 3903 Khmelnytskyi
Ukraine City Hospital #9 Kyiv Clinical Hospital, 3904 Kiev
Ukraine Vinnytsya Regional Clinical Hospital, 3902 Vinnytsya
United Kingdom St. James's University Hospital, 4403 Leeds
United Kingdom Hammersmith Hosptial, 4402 London
United Kingdom University College, 4401 London
United Kingdom Royal Victoria Infirmery, 4404 Newcastle Upon Tyne
United Kingdom Singleton Hospital, 4405 Swansea
United States 2085 Henry Tecklenburg Drive, 1001 Charleston South Carolina
United States Univ Nebraska Med Ctr. UNMC, 1005 Omaha Nebraska
United States Hospital of the University of Pennsylvania, Site 1002 Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Symphogen A/S Swedish Orphan Biovitrum

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  India,  Israel,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Ukraine,  United Kingdom, 

References & Publications (1)

Robak T, Windyga J, Trelinski J, von Depka Prondzinski M, Giagounidis A, Doyen C, Janssens A, Alvarez-Román MT, Jarque I, Loscertales J, Rus GP, Hellmann A, Jêdrzejczak WW, Kuliczkowski K, Golubovic LM, Celeketic D, Cucuianu A, Gheorghita E, Lazaroiu M, S — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) 6 weeks post dosing
Secondary Measurements of platelet counts From day 1 through week 6
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