Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00162006
First received: September 8, 2005
Last updated: April 28, 2014
Last verified: October 2006
  Purpose

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Subjects Who Qualify As Treatment Responders [ Time Frame: Baseline thru Day 15 post treatment ] [ Designated as safety issue: No ]
    Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.


Secondary Outcome Measures:
  • Time to achieve a platelet count > 50 x 109/L [ Designated as safety issue: No ]
  • duration of Duration of platelet response [ Designated as safety issue: No ]
  • Maximum Platelet Count [ Designated as safety issue: No ]
  • Safety In Terms Of Adverse Experiences [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: January 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 and <= 65 years
  • ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
  • Baseline platelet count of <= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
  • No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
  • For females of child bearing potential, use of adequate birth control measures during study participation
  • Written informed consent

Exclusion Criteria:

  • Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
  • Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
  • Underlying other autoimmune or lymphoproliferative disorder
  • Uncontrolled hypertension
  • Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
  • Malignancy or history of malignancy
  • Documented selective IgA deficiency (<= 10 mg/dL)
  • Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
  • History of severe adverse reactions to blood and/or blood products
  • Pregnancy or lactation
  • Positivity for HIV, or HCV antibodies, or HBsAg
  • History of unresponsiveness to IVIG defined as a peak increment in platelet count <= 20,000/µL coincident with the last IVIG treatment course prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162006

Locations
Czech Republic
Brno, Czech Republic
Hradec Králové, Czech Republic
Olomouc, Czech Republic
Prague, Czech Republic
Germany
Giessen, Germany
Halle/Saale, Germany
Hungary
Debrecen, Hungary
Györ, Hungary
Szeged, Hungary
Szombathely, Hungary
Poland
Lodz, Poland
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162006     History of Changes
Other Study ID Numbers: 160002
Study First Received: September 8, 2005
Last Updated: April 28, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Poland: Ministry of Health

Keywords provided by Baxter Healthcare Corporation:
Chronic idiopathic thrombocytopenic purpura

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014