Brief Summary

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Nov 2005

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

November 1, 2005

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed

4.6 years until next milestone

Results Posted

Study results publicly available

October 26, 2012

Completed

Last Updated

October 26, 2012

Status Verified

September 1, 2012

Enrollment Period

2.4 years

First QC Date

May 5, 2006

Results QC Date

September 27, 2012

Last Update Submit

September 27, 2012

Conditions

Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency

Keywords

Immunoglobulin IntravenousAgammaglobulinemiaHypogammaglobulinemiaCommon variable immunodeficiencyImmunoglobulin GChildren

Outcome Measures

Primary Outcomes (4)

The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
During each infusion, and within 48 or 72 hours after the end of each infusion.
Influence of Infusion Rate on Temporally-Associated AEs
The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and \> 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.
Within 72 hours after each infusion
Rate of AEs by Severity and Relationship
The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
For the duration of the study, up to approximately 29 months
Number of Subjects With Clinically Significant Changes in Vital Signs.
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Before, during, and after each infusion.

Secondary Outcomes (5)

Annualized Rate of Acute Serious Bacterial Infections.
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.
For the duration of the study, up to approximately 29 months.
Number of Days of Hospitalization.
For the duration of the study, up to approximately 29 months
Annualized Rate of Any Infection.
For the duration of the study, up to approximately 29 months.
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.
Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.

Study Arms (1)

IgPro10

EXPERIMENTAL

See Intervention Description

Drug: Immunoglobulins Intravenous (Human)

Interventions

Immunoglobulins Intravenous (Human)DRUG

Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

IgPro10

Eligibility Criteria

Age4 Years - 71 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)
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

You may not qualify if:

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

Contact the study team to confirm eligibility.