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Phase 2/3 Study of IGSC, 20% in PIDD

NCT01218438 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2021-07-20

Study results available
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Summary

The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

BIOLOGICAL

Immune Globulin Intravenous (Human), 10% Solution

Intravenous infusion with IGIV, 10%

DRUG

Immune Globulin Subcutaneous (Human), 20% Solution

Subcutaneous infusion with IGSC, 20%

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-28
Primary Completion
2015-03-13
Completion
2015-03-13

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 NCT01218438 on ClinicalTrials.gov