A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
An Open-label, Prospective, Multicenter Study to Investigate the Specificity of in Vivo Antibody Binding to Red Blood Cells in Subjects With Chronic Immune Thrombocytopenic Purpura (ITP) Treated With IgPro10 (Privigen®) Who Have Shown Signs of Hemolysis
2 other identifiers
interventional
57
3 countries
17
Brief Summary
It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not known in detail. The primary objective of this study was to investigate the specificity of antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of clinically relevant hemolysis following treatment with the intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an independent adjudication by a committee was performed for each patient with signs of hemolysis determined in the laboratory or in the clinic. This study was requested as a post-marketing commitment study by the United States Food and Drug Administration (FDA). By September 2014, no case of clinically significant intravascular hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol. The study was not restarted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2011
Typical duration for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
October 19, 2015
CompletedApril 8, 2016
September 1, 2015
2.8 years
July 7, 2011
September 16, 2015
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis
The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.
Within 3 days of infusion
Secondary Outcomes (1)
Responder Rate
Within 6 days after the first infusion
Study Arms (1)
IgPro10
EXPERIMENTALInterventions
IgPro10 will be administrated by IV infusion either a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first treatment.
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic ITP
- Age of 18 to 65 years
- Platelet count of ≤ 30 x 10\^9/L at screening
You may not qualify if:
- Planned splenectomy throughout the study period
- Treatment with immunoglobulin G for intravenous administration (IVIG) or anti-D immunoglobulin within 3 weeks prior to screening
- Use of drugs that have any pharmacological effect on the blood clotting system within 3 weeks prior to screening
- Known allergy or other severe reactions to blood products including intolerability to previous IVIG
- Known hyperprolinemia
- Red blood cell transfusion or erythropoietin treatment within the last 14 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (17)
UMHAT "Dr. Georgi Stranski" Clinic of Haematology
Pleven, Bulgaria
UMHAT "Sv. Georgi" Clinic of Haematology
Plovdiv, Bulgaria
Tokuda Hospital
Sofia, Bulgaria
Emergency Clinical County Hospital Baia Mare
Baia Mare, Romania
Emergency Clinical County Hospital Brasov
Brasov, Romania
Clinical Institute "Fundeni"
Bucharest, Romania
Universitary Hospital
Bucharest, Romania
Clinical City Hospital "Filantropia"
Craiova, Romania
City Hospital Oradea
Oradea, Romania
Emergency Clinical County Hospital Tg. Mures
Tg. Mures, Romania
Emergency Clinical City Hospital Timisoara
Timișoara, Romania
Oncomed SRL
Timișoara, Romania
Salvo-San-Ciobanca SRL
Zalău, Romania
Clinical Center of Serbia
Belgrade, Serbia
Clinical Hospital Bezanijska Kosa
Belgrade, Serbia
Clinical Hospital Zemun
Belgrade, Serbia
Clinical Center Nis
Niš, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure Manager
- Organization
- CSL Behring
Study Officials
- PRINCIPAL INVESTIGATOR
Wieslaw Jedrzejczak
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2011
First Posted
July 11, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
April 8, 2016
Results First Posted
October 19, 2015
Record last verified: 2015-09