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Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency

NCT02604810 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-10-04

Study results available
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Summary

This study was designed to determine a dose of weekly subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%) that produces steady-state AUC of total IgG that was non-inferior to that of the regularly administered intravenous dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency subjects. This study was also designed to determine steady state trough total IgG levels after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety and tolerability of IGSC 20%.

Conditions

  • Primary Immunodeficiency

Interventions

BIOLOGICAL

IGIV-C 10%

IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen

BIOLOGICAL

IGSC 20%

IGSC 20% weekly infusions with dose calculated based on previous IgG regimen

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-09-30
Completion
2017-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604810 on ClinicalTrials.gov