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Clinical Trials/NCT01199705
NCT01199705CompletedPhase 3

A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

CSL Behring10 sites in 1 country25 target enrollmentStarted: September 1, 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
25
Locations
10
Primary Endpoint
IgG Trough Level
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
  • •Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
  • •Written informed consent

Exclusion Criteria

  • •Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
  • •Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
  • •Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
  • •Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
  • •Pregnancy or nursing mother
  • •A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
  • •Participation in a study with other investigational product during this study and within 3 months prior to screening
  • •Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study

Arms & Interventions

IgPro20

Experimental

Intervention: Immune Globulin Subcutaneous (Human) (SCIG) (Biological)

Outcomes

Primary Outcomes

IgG Trough Level

Time Frame: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24

Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.

Secondary Outcomes

  • Number of Infection Episodes (Serious and Non-serious) by Study Period(Up to 36 weeks)
  • Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population(Up to 36 weeks)
  • Number of Days of Hospitalization Due to Infections by Study Period(Up to 36 weeks)
  • Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period(Up to 36 weeks)
  • Rate of Mild, Moderate, or Severe Local Reactions(For the duration of the study, up to 36 weeks)
  • Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population(Up to 36 weeks)
  • Duration of Use of Antibiotics for Infection Prophylaxis and Treatment(Up to 36 weeks)
  • Rate of All Adverse Events by Relatedness and Seriousness(For the duration of the study, up to 36 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (10)

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