DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Thrombocytopenic Purpura

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

Phase: Phase 2

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Baxter BioScience Investigator, Principal Investigator, Affiliation: Baxter BioScience

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Subjects Who Qualify As Treatment Responders

Secondary outcome:

Time to achieve a platelet count > 50 x 109/L

duration of Duration of platelet response

Maximum Platelet Count

Safety In Terms Of Adverse Experiences

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Brno, Czech Republic

Hradec Králové, Czech Republic

Olomouc, Czech Republic

Prague, Czech Republic

Giessen, Germany

Halle/Saale, Germany

Debrecen, Hungary

Györ, Hungary

Szeged, Hungary

Szombathely, Hungary

Lodz, Poland

Additional Information

Starting date: January 2003
Last updated: June 26, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015