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

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ClinicalTrials.gov Identifier: NCT00162006
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : January 18, 2018
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura (ITP) Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 1, 2003
Primary Completion Date : December 1, 2003
Study Completion Date : December 1, 2003


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Subjects Who Qualify As Treatment Responders [ Time Frame: Baseline thru Day 15 post treatment ]
    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 :
  1. Time to achieve a platelet count > 50 x 109/L
  2. duration of Duration of platelet response
  3. Maximum Platelet Count
  4. Safety In Terms Of Adverse Experiences

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162006


Locations
Czechia
Brno, Czechia
Hradec Králové, Czechia
Olomouc, Czechia
Prague, Czechia
Germany
Giessen, Germany
Halle/Saale, Germany
Hungary
Debrecen, Hungary
Györ, Hungary
Szeged, Hungary
Szombathely, Hungary
Poland
Lodz, Poland
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
More Information

ClinicalTrials.gov Identifier: NCT00162006     History of Changes
Other Study ID Numbers: 160002
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Shire:
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
Pharmaceutical Solutions
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs