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Immune Globulin Subcutaenous (Human), 20%

NCT01412385 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-05-05

No results posted yet for this study

Summary

The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for patients with primary immunodeficiency (PID) diseases.

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

BIOLOGICAL

Immune Globulin Subcutaneous (Human), 20%

Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects)

BIOLOGICAL

Immune Globulin Intravenous (Human), 10%

Intravenous infusion (regulated via a pump)

BIOLOGICAL

Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)

Subcutaneous infusion (regulated via a pump)

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-20
Primary Completion
2014-05-13
Completion
2014-05-13

Countries

  • Austria
  • Germany
  • Hungary
  • Sweden
  • United Kingdom

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 NCT01412385 on ClinicalTrials.gov