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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162006

Enrollment

Registered

2005-09-13

Start date

2003-01-13

Completion date

2003-12-03

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenic Purpura (ITP)

Keywords

Chronic idiopathic thrombocytopenic purpura

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.

Interventions

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Subjects Who Qualify As Treatment Responders	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

Measure	Time frame
Time to achieve a platelet count > 50 x 109/L	Screening visit
Duration of platelet response	Screening visit
Maximum Platelet Count	Screening visit
Number of Adverse Experiences	Throughout the study period of approximately 11 months

Countries

Czechia, Germany, Hungary, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026