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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02269163
Other study ID # 2004C009G
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 26, 2016
Est. completion date January 11, 2019

Study information

Verified date November 2021
Source Prometic Biotherapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date January 11, 2019
Est. primary completion date January 11, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subject is male or female between the ages of 2 and 80 years at Screening. 2. 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. 3. 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]). 4. 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. Exclusion Criteria: 1. 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. 2. Subject has ever had a history of severe anaphylactic or anaphylactoid reaction to immunoglobulins or other blood products. 3. 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. 4. 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. 5. Subject has had cancer in the past 5 years, except for basal cell or squamous cell cancers of the skin. 6. Subject has had a documented active infection within 7 days prior to Screening, or subject is on continuous prophylactic antibiotics. 7. Subject is positive for human immunodeficiency virus (HIV)-1 or HIV-2, a positive hepatitis C virus (HCV) or hepatitis B virus (HBV). 8. Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the upper limit of normal (ULN). 9. Subject has serum creatinine >1.5 times the ULN or a severe chronic condition such as renal failure with proteinuria. 10. Subject has anemia with a hemoglobin level =8 g/dL. 11. Subject has severe neutropenia with neutrophil count =1000 per mm?3 or has lymphopenia with <500 per/ mm?3. 12. Subject is taking prednisone at a dose =0.15 mg/kg/day and receiving other immunosuppressive drugs or chemotherapy. 13. 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. 14. Subject has known decreased Protein C and/or Protein S levels. 15. Subject is positive for antibodies to ß2GPI and/or ß2GPI DI at Screening. 16. Female subject who is pregnant, breast-feeding, or planning a pregnancy during the course of the study. 17. A history of epilepsy or multiple episodes of migraine (defined as at least one episode within 6 months of enrolment) not completely controlled by medication, or any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study in the Investigator's opinion.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Immune Globulin Intravenous
Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product
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)

Locations

Country Name City State
United States Bellingham Asthma, Allergy and Immunology Clinic Bellingham Washington
United States Immunoe International Research Centennial Colorado
United States Rush University Medical Center Chicago Illinois
United States Optimed Research Columbus Ohio
United States Dallas Allergy Immunology Dallas Texas
United States National Jewish Hospital Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States Fort Wayne Medical Institute Fort Wayne Indiana
United States University of California, Irvine Irvine California
United States Children's Hospital Los Angeles Los Angeles California
United States Allergy Associates of the Palm Beaches North Palm Beach Florida
United States St. Louis University Saint Louis Missouri
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida

Sponsors (2)

Lead Sponsor Collaborator
Prometic Biotherapeutics, Inc. Atlantic Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Trough Levels of IgG (Total) Prior to Each Prometic IGIV 10% Infusion Subject's total IgG levels will be assessed prior to each Prometic IGIV 10% infusion One year
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