Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00322556
• Date of registration: 05/05/2006
• Prospective Registration: No
• Primary sponsor: CSL Behring
• Public title: Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
• Scientific title: A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)
• Date of first enrolment: November 2005
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00322556
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Program Coordinator
• Affiliation: CSL Behring

Key inclusion & exclusion criteria

Key Inclusion Criteria:

Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia)
who:

Participated in the Phase III clinical study with intravenous IgPro10 (study number
ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)

OR

Were = 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg
IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were
interested in participating in the Phase III clinical study with subcutaneous IgPro20
(study number ZLB04_009CR) (referred to as 'new' subjects)

Written informed consent

Key Exclusion Criteria:

Diagnosis of epilepsia

Insulin dependent diabetes

Administration of steroids (daily = 0.15 mg prednisone equivalent/kg/day) or other
immunosuppressive drugs

History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure,
severe hypertension



Age minimum: 4 Years
Age maximum: 71 Years
Gender: All

Health Condition(s) or Problem(s) studied

Agammaglobulinemia

Common Variable Immunodeficiency

IgG Deficiency

Intervention(s)

Drug: Immunoglobulins Intravenous (Human)

Primary Outcome(s)

Rate of AEs by Severity and Relationship [Time Frame: For the duration of the study, up to approximately 29 months]

Number of Subjects With Clinically Significant Changes in Vital Signs. [Time Frame: Before, during, and after each infusion.]

Influence of Infusion Rate on Temporally-Associated AEs [Time Frame: Within 72 hours after each infusion]

The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). [Time Frame: During each infusion, and within 48 or 72 hours after the end of each infusion.]

Secondary Outcome(s)

Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations. [Time Frame: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.]

Number of Days of Hospitalization. [Time Frame: For the duration of the study, up to approximately 29 months]

Annualized Rate of Any Infection. [Time Frame: For the duration of the study, up to approximately 29 months.]

Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness. [Time Frame: For the duration of the study, up to approximately 29 months.]

Annualized Rate of Acute Serious Bacterial Infections. [Time Frame: For the duration of the study, up to approximately 29 months]

Secondary ID(s)

ZLB05_006CR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00322556