Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01461018
NCT01461018CompletedPhase 3

A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency

CSL Behring11 sites in 1 country22 target enrollmentStarted: October 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
22
Locations
11
Primary Endpoint
Annualized rate of infection episodes
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).

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

  • •Subjects who have completed the preceding follow-up study ZLB07_001CR.
  • •Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject.

Exclusion Criteria

  • •Pregnancy or nursing mother.
  • •Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
  • •Subjects who are planning to donate blood during the study.
  • •Known or suspected antibodies to the IMP, or to excipients of the IMP.
  • •Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.

Outcomes

Primary Outcomes

Annualized rate of infection episodes

Time Frame: Up to 36 months

Secondary Outcomes

  • Number of subjects with adverse events (AEs)(Up to 36 months)
  • Percentage of subjects with adverse events (AEs)(Up to 36 months)
  • Rate of AEs per infusion(Up to 36 months)
  • Annualized rate of clinically documented serious bacterial infections (SBIs)(Up to 36 months)
  • Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections(Up to 36 months)
  • Number of days of hospitalization due to infections(Up to 36 months)
  • Duration of use of antibiotics for infection prophylaxis and treatment(Up to 36 months)
  • Median serum IgG concentration(Up to 36 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

Loading locations...

Similar Trials

Completed
Phase 3
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)Primary Immune Deficiency Disorder
NCT01458171CSL Behring23
Completed
Phase 3
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10Immune Thrombocytopenic Purpura
NCT00168038CSL Behring58
Completed
Phase 3
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisGeneralized Myasthenia Gravis
NCT04818671argenx184
Completed
Phase 3
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)AgammaglobulinemiaIgG DeficiencyCommon Variable Immunodeficiency
NCT00322556CSL Behring55
Terminated
Phase 3
Long-Term Study of IGIV, 10% in Alzheimer´s DiseaseAlzheimer´s Disease
NCT01736579Baxalta now part of Shire6