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

NCT02269163 | Completed Phase 3 Results DMC

• 1 other identifier: 2004C009G
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 13

Brief 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

Outcome Measures

Primary Outcomes (1)

• Annual Rate of Occurrence of Serious Bacterial Infections (SBI)

  SBIs were calculated for each subject as 52n/w, where n is the number of reported SBIs and w is the number of weeks on study. For the combined cohorts only, a 99% one-sided (upper) confidence limit for the incidence rate of SBIs (scaled to represent 12 months exposure if necessary) was derived, and the objective of demonstrating that the true infection rate was below 1 per subject per year was considered established if this upper limit was less than 1. To calculate the confidence limit, a negative binomial regression model will be used. This model includes an overdispersion parameter to account for possible intra-subject correlation as well as the actual time period each subject is on the study as an offset variable.

  One year

Secondary Outcomes (1)

• Trough Levels of IgG (Total) Prior to Each Prometic IGIV 10% Infusion

  One year

Study Arms (2)

Gammargard, Gammaplex, Gamunex, or Octogam Treatment Period

ACTIVE COMPARATOR

Subjects who enroll in the study while on Gammargard, Gammaplex, Gamunex, or Octogam IGIV Product and need to wait for the scheduled start of Prometic IGIV (10%) treatment will continue on their usual dose and treatment cycle with Gammargard, Gammaplex, Gamunex, or Octogam IVIG Product during this period.

Biological: Immune Globulin Intravenous

Prometic IGIV 10% Treatment Period

EXPERIMENTAL

Subjects will receive Prometic Immune Globulin Intravenous 10%

Biological: Prometic's Immune Globulin Intravenous 10%

Interventions

Immune Globulin Intravenous BIOLOGICAL

Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product

Gammargard, Gammaplex, Gamunex, or Octogam Treatment Period

Prometic's Immune Globulin Intravenous 10% BIOLOGICAL

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

Prometic IGIV 10% Treatment Period

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female between the ages of 2 and 80 years at Screening.
• Female subjects of childbearing potential must agree to employ adequate birth control measures, as determined by their IRB/IEC, for the duration of the study.
• The subject must have one of the following three diagnoses (isolated PIDD of other types will be excluded):
• Common variable immunodeficiency
• X-linked agammaglobulinemia
• Hyper-IgM syndrome and documented low IgG levels (\<4.5 mg/mL \[450 mg/dL\]).
• Subjects must have been treated with a stable dose of immune globulin administered intravenously (IGIV) or subcutaneously (IGSC) and has documented trough or steady state IgG levels of ≥ 5 mg/mL.

You may not qualify if:

• Subject has secondary immunodeficiency or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency; has known hypoalbuminemia (\<3 gm/dL), protein-losing enteropathy, or nephrotic syndrome.
• Subject has ever had a history of severe anaphylactic or anaphylactoid reaction to immunoglobulins or other blood products.
• Subject has a known history of immunoglobulin A (IgA) deficiency and known anti-IgA antibodies, thrombotic event, such as deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, at any time.
• Subject has received blood products except IGIV, IGSC, or albumin within the previous 12 months or has participated in another study (except for IGIV, IGSC studies) within the previous 4 weeks.
• Subject has had cancer in the past 5 years, except for basal cell or squamous cell cancers of the skin.
• Subject has had a documented active infection within 7 days prior to Screening, or subject is on continuous prophylactic antibiotics.
• Subject is positive for human immunodeficiency virus (HIV)-1 or HIV-2, a positive hepatitis C virus (HCV) or hepatitis B virus (HBV).
• Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 times the upper limit of normal (ULN).
• Subject has serum creatinine \>1.5 times the ULN or a severe chronic condition such as renal failure with proteinuria.
• Subject has anemia with a hemoglobin level ≤8 g/dL.
• Subject has severe neutropenia with neutrophil count ≤1000 per mmᴧ3 or has lymphopenia with \<500 per/ mmᴧ3.
• Subject is taking prednisone at a dose ≥0.15 mg/kg/day and receiving other immunosuppressive drugs or chemotherapy.
• Subject has known atrial fibrillation requiring anticoagulant therapy; congestive heart failure (New York Heart Association Class III/IV); cardiomyopathy; or cardiac arrhythmia associated with thromboembolic events, unstable or advanced ischemic heart disease, or hyperviscosity.
• Subject has known decreased Protein C and/or Protein S levels.
• Subject is positive for antibodies to β2GPI and/or β2GPI DI at Screening.

Sponsors & Collaborators

• Prometic Biotherapeutics, Inc.: lead
• Atlantic Research Group: collaborator

Study Sites (13)

University of California, Irvine

Irvine, California, 92697, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Immunoe International Research

Centennial, Colorado, 80112, United States

Location

National Jewish Hospital

Denver, Colorado, 80206, United States

Location

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Fort Wayne Medical Institute

Fort Wayne, Indiana, 46815, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Optimed Research

Columbus, Ohio, 43236, United States

Location

Dallas Allergy Immunology

Dallas, Texas, 75230, United States

Location

Bellingham Asthma, Allergy and Immunology Clinic

Bellingham, Washington, 98225, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

gamma-Globulins

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director, External Biologics
• Organization: Prometic Biotherapeutics Inc

clinical@prometic.com

438-802-3497

Study Officials

• James Moy, MD

  Rush University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: January 26, 2016
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: November 5, 2021
• Results First Posted: August 20, 2021

Record last verified: 2021-11

Locations

US (13)