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Trial record 1 of 1 for:    PlasmaCap | Primary Immune Deficiency Disorder | United States
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Study of PlasmaCap IG in Adults and Children With PIDD

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ClinicalTrials.gov Identifier: NCT03238079
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Therapure Biopharma Inc

Brief Summary:
The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares with other 10% intravenous immunoglobulin (IGIV) products currently licensed in North America for the treatment of subjects with primary immune deficiency diseases (PIDD).

Condition or disease Intervention/treatment Phase
Primary Immune Deficiency Diseases (PIDD) Biological: 10% IGIV Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children With Primary Immune Deficiency Diseases
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Open-Label 10% IGIV

IMP will be administered every 21 or 28 days in accordance with the subject's weekly regimen at screening for a period of 12 months. Subjects on a 21-day regimen will receive approximately 17 infusions, and subjects on a 28-day regimen will receive approximately 13 infusions.

The starting dose will be the previous IGIV dose or a dose calculated from the previous SCIG dose up to a maximum of 900 mg/kg/mo.

Biological: 10% IGIV
300-900 mg/kg
Other Name: Human Immunoglobulin



Primary Outcome Measures :
  1. Mean acute Serious Bacterial Infection (SBI) rate [ Time Frame: 1 year ]
    The primary efficacy objective of the study is to demonstrate the efficacy of the IMP by determining that the mean annual acute SBI rate (as defined in Appendix 20.1) is statistically significantly lower than one infection per subject per year.


Secondary Outcome Measures :
  1. Immunoglobulin G (IgG) trough concentration [ Time Frame: up to 12 months per subject ]
    The average serum total IgG trough concentrations prior to each infusion

  2. Days unable to perform daily activities [ Time Frame: up to 12 months per subject ]
    The number of days unable to perform daily activities

  3. Therapeutic IgG levels [ Time Frame: up to 12 months per subject ]
    The ability of the IMP to maintain stable, therapeutic IgG levels



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Ages Eligible for Study:   2 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a confirmed clinical diagnosis of a PIDD, which requires treatment with IGIV:
  • Subject/guardian has provided written informed consent (and assent, as applicable).
  • Subject is between the ages of 2 and 70 years.
  • Subject has received regular IGIV therapy at 21- or 28-day (±4 days) intervals for at least three consecutive months at a dose between 300-900 mg/kg/month prior to Screening or;
  • Subject has received commercial SCIG at a dose of 300-900 mg/kg/month on any dosing schedule for at least 12 consecutive weeks prior to Screening. Subjects on SCIG must have received and tolerated IGIV treatment prior to SCIG treatment.
  • Subject has a documented trough of ≥500 mg/dL in the 6 months prior to screening.
  • Females of childbearing potential must be willing to use an effective form of birth control (eg, oral contraceptives) for the duration of the study, per IRB/REB guidelines.
  • Subject agrees to comply with the requirements of the protocol.

Exclusion Criteria:

  • Subject has secondary immunodeficiency.
  • Subject has history of thrombotic events, such as deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, etc within the year prior to screening.
  • Subject has had an immune globulin associated arterial or venous thrombotic/thromboembolic event (TEE) within 7 days of infusion or a TEE that is not associated with an immune globulin within one year of screening.
  • Subject has received blood products (except for IGIV, SCIG, or albumin) within 6 months of screening.
  • Subject has anemia (≤8.5 g/dL).
  • Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3.0 times the upper limit of normal (ULN).
  • Subject has severe neutropenia (≤1000 neutrophils per mm3).
  • Subject is receiving other immunosuppressive or immunomodulatory drugs or chemotherapy.
  • Subject is taking or has taken within the four weeks prior to screening prednisone at ≥0.15 mg/kg/day for more than 10 days.
  • Subject has ever had a severe anaphylactic reaction to a blood or IgG product.
  • Subject has lymphoid malignancy, leukemia, or any other history of malignancy within the past five years, except squamous cell or basal cell carcinoma of the skin (not melanoma).
  • Subject has hypoalbuminemia, protein-losing enteropathy, or proteinuria greater than 300 mg/24 hours except for subjects with documented orthostatic proteinuria.
  • Subject has immunoglobulin A (IgA) deficiency with known antibodies to IgA.
  • Female who is pregnant, breastfeeding, or planning a pregnancy during the course of the study (women who become pregnant during the study will be withdrawn from the study).
  • Any condition that is likely to interfere with evaluation of IMP or satisfactory conduct of the trial in the PI's opinion.
  • Subjects who may not be compliant or have a history of non-compliance in the opinion of the PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238079


Contacts
Contact: Jacinthe Guindon 1-289-327-2253 jguindon@therapurebio.com

Locations
United States, California
University of California Recruiting
Los Angeles, California, United States, 92697
United States, Colorado
IMMUNOe Health & Research Centers Recruiting
Centennial, Colorado, United States, 80112
United States, Florida
Allergy Associates of the Palm Beaches, P.A. Recruiting
West Palm Beach, Florida, United States, 33408
United States, Maryland
Institute for Asthma and Allergy, PC Recruiting
Chevy Chase, Maryland, United States, 20815
United States, North Carolina
Optimed Research LTD Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
Optimed Research LTD Recruiting
Columbus, Ohio, United States, 43235
United States, Texas
Allergy Partners of North Texas Recruiting
Dallas, Texas, United States, 75230
AARA Research Center Recruiting
Dallas, Texas, United States, 75231
AAICPA Recruiting
Irving, Texas, United States, 75063
United States, Washington
Mid-Columbia Research Not yet recruiting
Richland, Washington, United States, 99352
United States, Wisconsin
The Medical College of Wisconsin, Inc. Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Therapure Biopharma Inc
Investigators
Study Director: Mark Krause Therapure Biopharma

Responsible Party: Therapure Biopharma Inc
ClinicalTrials.gov Identifier: NCT03238079     History of Changes
Other Study ID Numbers: TBI-001-IGIV
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Deficiency Diseases
Immune System Diseases
Malnutrition
Nutrition Disorders
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs