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

March 10, 2016 updated by: CSL Behring

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • UMHAT "Dr. Georgi Stranski" Clinic of Haematology
      • Plovdiv, Bulgaria
        • UMHAT "Sv. Georgi" Clinic of Haematology
      • Sofia, Bulgaria
        • Tokuda Hospital
  • Romania
      • Baia Mare, Romania
        • Emergency Clinical County Hospital Baia Mare
      • Brasov, Romania
        • Emergency Clinical County Hospital Brasov
      • Bucharest, Romania
        • Clinical Institute "Fundeni"
      • Bucharest, Romania
        • Universitary Hospital
      • Craiova, Romania
        • Clinical City Hospital "Filantropia"
      • Oradea, Romania
        • City Hospital Oradea
      • Tg. Mures, Romania
        • Emergency Clinical County Hospital Tg. Mures
      • Timisoara, Romania
        • Emergency Clinical City Hospital Timisoara
      • Timisoara, Romania
        • Oncomed SRL
      • Zalau, Romania
        • Salvo-San-Ciobanca SRL
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
      • Belgrade, Serbia
        • Clinical Hospital Bezanijska Kosa
      • Belgrade, Serbia
        • Clinical Hospital Zemun
      • Nis, Serbia
        • Clinical Center Nis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IgPro10
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.
Other Names:
  • Privigen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis
Time Frame: Within 3 days of infusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate
Time Frame: Within 6 days after the first infusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Investigators

  • Principal Investigator: Wieslaw Jedrzejczak, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgPro10_4001
  • 2011-000263-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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