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Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)

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ClinicalTrials.gov Identifier: NCT03033745
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Brief Summary:
This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of ≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions), volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push Flow Rate Cohort (2 to 7 infusions per week), flow rate per injection site of 25 to 30 mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute). Each cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate cohort), repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate cohort). After 4 infusion weeks at each level, qualifying subjects (responders) will switch to the next infusion parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose will remain unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per week range); only the respective infusion parameter under evaluation will change.

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency Drug: IgPro20 Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018


Arm Intervention/treatment
Experimental: IgPro20 (Pump-Assisted Volume Cohort)
Weekly volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
Drug: IgPro20
A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
Other Name: Hizentra

Experimental: IgPro20 (Pump Assisted Flow Rate Cohort)
Weekly flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
Drug: IgPro20
A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
Other Name: Hizentra

Experimental: IgPro20 (Manual Push Flow Rate Cohort)
Frequent (ie, 2 to 7 times per week) flow rates per injection site of 25 to 30 mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
Drug: IgPro20
A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
Other Name: Hizentra




Primary Outcome Measures :
  1. Percentage of Responders [ Time Frame: At the end of 4 weeks for each planned infusion volume/flow rate parameter level ]
    A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions (ie, 5-17) during 4 weeks corresponding to a certain flow rate level ([ie, 2-7 times per week], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third of the subjects in the corresponding cohort are responders at that infusion parameter level.


Secondary Outcome Measures :
  1. Rate of total adverse events (AEs) [ Time Frame: Up to 17 weeks. ]
    The rate of total adverse events (AEs) per subject and per infusion by cohort and by each of the infusion parameter levels within the cohort.

  2. Rate of local reactions [ Time Frame: Up to 17 weeks. ]
    The rate of local reactions per subject and per infusion by cohort and by each of the infusion parameter levels within the cohort.

  3. Time to onset of local reactions [ Time Frame: Up to 17 weeks ]
    The time to onset of local reactions per subject and per infusion by cohort and by each of the infusion parameter levels within the cohort.

  4. Severity of local reactions [ Time Frame: Up to 17 weeks ]
    Severity of local reactions per subject and per infusion by cohort and by each of the infusion parameter levels within the cohort.

  5. Duration of local reactions [ Time Frame: Up to 17 weeks ]
    Duration of local reactions per subject and per infusion by cohort and by each of the infusion parameter levels within the cohort.

  6. Percentage of infusions experiencing no severe local reactions [ Time Frame: Up to 17 weeks ]
    For all cohorts: Tolerability of a certain infusion parameter, i.e. percentage of infusions per cohort by volume/flow rate subgroup experiencing no severe local reactions for each of the infusion parameter levels.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female on stable dose of IgPro20 (Hizentra) therapy.
  • Women of childbearing potential must be using and agree to continue using medically approved contraception (which must be discussed with the study doctor) and must have a negative pregnancy test at screening.
  • Subjects with PID, eg, with a diagnosis of common variable immunodeficiency or X-linked agammaglobulinemia, as defined by the Pan American Group for Immune Deficiency and the European Society of Immune Deficiencies.
  • With infusion parameters as specified below:

Pump-Assisted Flow Rate Cohort subjects only

  • Experience with pump-assisted infusions of IgPro20 at the tolerated flow rate of 25 mL/h per injection site for at least 1 month prior to Day 1.

Pump-Assisted Volume Cohort subjects only

  • Total weekly IgPro20 dose of ≥ 50 mL (≥ 10 g).
  • Experience with pump-assisted infusions of IgPro20 at tolerated volumes of 25 mL/injection site for at least 1 month prior to Day 1.

Manual Push Flow Rate Cohort subjects only

  • Experience with frequent (2-7 times per week) infusions of IgPro20 at the tolerated flow rate of approximately 0.5 mL/min (equivalent of 25-30 mL/h) per injection site for at least 1 month prior to Day 1. The dose (volume) per injection site should not exceed 25 mL.

Exclusion Criteria:

  • Ongoing serious bacterial infections at the time of screening.
  • Other significant medical conditions that could increase the risk to the subject.
  • Females who are pregnant, breast feeding, or planning a pregnancy during the course study.
  • Participation in a study with an Investigational Medicinal Product (IMP) other than IgPro20 within three months prior to enrollment.

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): NCT03033745


Contacts
Contact: Central Contact Clincal Trials Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
United States, Alabama
Clinical Research Center of Alabama Recruiting
Birmingham, Alabama, United States, 35209
Contact: Use Central Contact       clinicaltrials@CSLBehring.com   
Principal Investigator: John Anderson         
United States, Arizona
Research Solutions of Arizona Recruiting
Litchfield Park, Arizona, United States, 85340
Contact: Use Central Contact       clinicaltrials@CSLBehring.com   
Principal Investigator: Connie Hsu         
United States, Florida
University of Southern Florida Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Use Central Contact       clinicaltrials@cslbehring.com   
Principal Investigator: Panida Sriaroon, MD         
United States, Georgia
Georgia Pollens Clinical Research Centers Recruiting
Albany, Georgia, United States, 31707
Contact: Use Central Contact       clinicaltrials@cslbehring.com   
Principal Investigator: Tracy Bridges, MD         
United States, New York
Long Island Jewish Medical Center Recruiting
Great Neck, New York, United States, 11021
Contact: Use Central Contact       clinicaltrials@CSLBehring.com   
Principal Investigator: Vincent Bonagura         
Icahn Medical Institute Recruiting
New York, New York, United States, 10029
Contact: Use Central Contact       clinicaltrials@cslbehring.com   
Principal Investigator: Paul Maglione, MD         
Center for Clinical Research Rochester General Hospital Recruiting
Rochester, New York, United States, 14607
Contact: Use Central Contact       clinicaltrials@cslbehring.com   
Principal Investigator: Shahzad Mustafa, MD         
United States, North Carolina
Levine Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Use Central Contact       clinicaltrials@CSLBehring.com   
Principal Investigator: Niraj Patel         
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27705
Contact: Use Central Contact       clinicaltrials@CSLBehring.com   
Principal Investigator: Patricia Lugar, MD         
United States, Wisconsin
Medical College of Wisconsin Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Use Central Contact       clinicaltrials@CSLBerhing.com   
Principal Investigator: Juthaporn Cowan, MD         
Canada, Quebec
McGill University Recruiting
Montréal, Quebec, Canada, H4A3J1
Contact: Use Central Contact       clinicaltrials@cslbehring.com   
Principal Investigator: Donald Vinh, MD         
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Study Physician CSL Behring

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03033745     History of Changes
Other Study ID Numbers: IgPro20_4004
2016-003799-33 ( EudraCT Number )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Immune System Diseases