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

Phase 2

Completed

• Conditions: Immune Thrombocytopenic Purpura
• Interventions: Drug: Sym001

• Registration Number: NCT00718692
• Lead Sponsor: Symphogen A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Disposition First Submitted: 2015-11-25
• Disposition First Submitted QC: 2016-04-11
• Disposition First Posted: 2016-05-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sym001	Patients treated with Sym001

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)	6 weeks post dosing

Secondary Outcome Measures

Name	Time	Method
Measurements of platelet counts	From day 1 through week 6

Trial Locations

Locations (59)

Univ Nebraska Med Ctr. UNMC, 1005; 🇺🇸 Omaha, Nebraska, United States

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; 🇧🇪 Brugge, Belgium

Research Site 3202; 🇧🇪 Leuven, Belgium

Research Site 3201; 🇧🇪 Yvoir, Belgium

Research Site 4906, 4907; 🇩🇪 Berlin, Germany

Research Site 4903; 🇩🇪 Duisburg, Germany

Research Site 4905; 🇩🇪 Essen, Germany

Reseach Site 4908; 🇩🇪 Halle, Germany

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