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Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%

NCT02269163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-11-05

Study results available
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Summary

Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product \[IMP\]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).

Conditions

  • Primary Immunodeficiency

Interventions

BIOLOGICAL

Immune Globulin Intravenous

Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product

BIOLOGICAL

Prometic's Immune Globulin Intravenous 10%

Liquid formulation of Prometic Immune Globulin Intravenous 10% (human) in 50 mL vials containing 100 mg/mL of immunoglobulin G (IgG)

Sponsors & Collaborators

  • Atlantic Research Group

    collaborator OTHER

  • Prometic Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • James Moy, MD · Rush University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2016-01-26
Primary Completion
2019-01-11
Completion
2019-01-11

Countries

  • United States

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 NCT02269163 on ClinicalTrials.gov