Clinical trial NCT01390649: A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immune Thrombocytopenic Purpura
Keywords: ITP
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis
timeFrame: Within 3 days of infusion
Secondary outcomes:
measure: Responder Rate
timeFrame: Within 6 days after the first infusion
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski" Clinic of Haematology
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sv. Georgi" Clinic of Haematology
city: Sofia
country: Bulgaria
facility: Tokuda Hospital
city: Baia Mare
country: Romania
facility: Emergency Clinical County Hospital Baia Mare
city: Brasov
country: Romania
facility: Emergency Clinical County Hospital Brasov
city: Bucharest
country: Romania
facility: Clinical Institute "Fundeni"
city: Bucharest
country: Romania
facility: Universitary Hospital
city: Craiova
country: Romania
facility: Clinical City Hospital "Filantropia"
city: Oradea
country: Romania
facility: City Hospital Oradea
city: Tg. Mures
country: Romania
facility: Emergency Clinical County Hospital Tg. Mures
city: Timisoara
country: Romania
facility: Emergency Clinical City Hospital Timisoara
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Zalau
country: Romania
facility: Salvo-San-Ciobanca SRL
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Hospital Zemun
city: Nis
country: Serbia
facility: Clinical Center Nis
Study officials:
affiliation: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
name: Wieslaw Jedrzejczak
role: PRINCIPAL_INVESTIGATOR
References: