NCT02269163

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

A Phase 3, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and PK of ProMetic BioTherapeutics IGIV (Human) 10% in Adults and Children With Primary Immunodeficiency Diseases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Prometic Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a pivotal Phase 3, open-label, single-arm, multicenter study to assess the tolerability, safety, efficacy, and Pharmacokinetics of the Investigational Medicinal Product in adults and children with Primary Immunodeficiency Diseases (PIDD). A total of approximately 75 subjects aged 2-80 years will be enrolled in the study. Subjects who switch from an investigational immune globulin or subcutaneous immune globulin (IGSC) are required to receive a stable dose of commercial product (CP), which is a licensed commercially available immune globulin intravenous (IGIV) product for at least 3 cycles before they can be given the Investigational Medicinal Product . This study schema will result in the Commercial Product Treatment Period and Investigational Medicinal Product Treatment Period. All subjects will be treated on an outpatient basis with the Investigational Medicinal Product for approximately 1 year, with the dose and schedule based on their previous IGIV treatment regimen (21-day or 28-day dosing interval). A subset of subjects will participate in a Pharmacokinetics sub-study. The primary objective of the study is to examine the rate of clinically documented serious bacterial infections (SBIs) in subjects treated with the Investigational Medicinal Product to achieve a rate of less than one SBI per year.

Conditions

• Primary Immunodeficiency

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-01-26
• Primary completion: 2019-01-11
• Completion: 2019-01-11
• First posted: 2014-10-20
• Last updated: 2021-11-05
• Results posted: 2021-08-20

Locations

13 sites across 1 country: United States