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

Immune Thrombocytopenic Purpura Clinical Trial

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.

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
• 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
• 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.

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

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