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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 | Clinical Trials | Clareo Health

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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

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

NCT00162006•Baxalta now part of Shire

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (11)

Brno, Czechia

Hradec Králové, Czechia

Olomouc, Czechia

Prague, Czechia

Giessen, Germany

Halle, Germany

Debrecen, Hungary

Győr, Hungary

Szeged, Hungary

Szombathely, Hungary

Key Dates

Start Date

January 13, 2003

Primary Completion Date

December 3, 2003

Completion Date

December 3, 2003

Last Updated

May 3, 2021

Enrollment

ACTUAL participants

Conditions

Immune Thrombocytopenic Purpura (ITP)

Interventions

Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution

DRUG

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

NCT06722235

Immune Thrombocytopenic Purpura (ITP)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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