A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

Immune Thrombocytopenic Purpura Clinical Trial

Official title:

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

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

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

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