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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01390649
Other study ID # IgPro10_4001
Secondary ID 2011-000263-27
Status Completed
Phase Phase 4
First received July 7, 2011
Last updated September 16, 2015
Start date November 2011
Est. completion date September 2014

Study information

Verified date September 2015
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority Romania: Ministry of Public HealthUnited States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencySerbia and Montenegro: Agency for Drugs and Medicinal DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosis of chronic ITP

- Age of 18 to 65 years

- Platelet count of = 30 x 10^9/L at screening

Exclusion Criteria:

- 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
IgPro10
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.

Locations

Country Name City State
Bulgaria UMHAT "Dr. Georgi Stranski" Clinic of Haematology Pleven
Bulgaria UMHAT "Sv. Georgi" Clinic of Haematology Plovdiv
Bulgaria Tokuda Hospital Sofia
Romania 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 Timisoara
Romania Oncomed SRL Timisoara
Romania Salvo-San-Ciobanca SRL Zalau
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Hospital Bezanijska Kosa Belgrade
Serbia Clinical Hospital Zemun Belgrade
Serbia Clinical Center Nis Nis

Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

Bulgaria,  Romania,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Responder Rate The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to = 50 x 10^9/L after the first IgPro10 administration). Within 6 days after the first infusion No
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