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

Completed · Phase 2

Conditions studied: Immune Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID

NCT00718692

Run by

Symphogen A/S

People needed

61

Starts

2008-07-01

Expected to finish

2011-10-01

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Hospital of the University of Pennsylvania, Site 1002 — Philadelphia, Pennsylvania, United States
• 2085 Henry Tecklenburg Drive, 1001 — Charleston, South Carolina, 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, India
• MS Ramaiah Memorial Hospital, 9108 — Bangalore, India
• Narayana Hrudayalaya Hospitals, 9105 — Bangalore, India
• Columbia Asia Referral Hospital-Yeshwanthpur, 9101 — Bangalore, India
• Aysha Hospital Pvt. Ltd., 9109 — Chennai, India
• Apollo Hospital, 9104 — Hyderabad, India
• Kasturba Medical College Hospital, 9103 — Udupi, India
• 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 — Petah Tikva, Israel
• Univ Nebraska Med Ctr. UNMC, 1005 — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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