RECRUITING

An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)

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Conditions

Primary ImmunodeficiencyImmunoglobulin replacement therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerability of IgPro20 in IG treatment-naïve participants with PID who are aged greater than or equal to (\>=) 18 years.

Official Title

An Open-label, Multicenter Study to Assess the Pharmacokinetics, Safety, and Tolerability of Immune Globulin Subcutaneous (Human) IgPro20 in IG Treatment-naïve Subjects With Primary Immunodeficiency

Quick Facts

Study Start:2025-07-15
Study Completion:2026-05-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07076446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be aged \>=18 years.
  2. * Participants must have a confirmed and documented diagnosis of PID, must be IG treatment-naïve and have an IgG level less than or equal to (\<=) 400 milligrams per deciliter(mg/dL) at Screening.
  1. * Participants with hyperprolinemia.
  2. * Participants who are receiving the following medications:
  3. * Systemic corticosteroids (prednisone or equivalent; average daily dose of greater than \[\>\] 15 mg) from 4 weeks before Screening.
  4. * Any dose of systemic immunosuppressants within 9 months or 5 times the half-life (t½) plus 6 months before Screening, whichever is longer.
  5. * Any dose of biologic therapies with influence on the immune system (eg, tumor necrosis factor inhibitors, interleukin inhibitors, B-cell inhibitors), including investigational agents, within 12 months or 5 times the t½ plus 6 months before Screening, whichever is longer.
  6. * Participants who are currently receiving anti-coagulation therapy.
  7. * Participants with hypoalbuminemia, protein-losing enteropathies, and kidney diseases with proteinuria.
  8. * Participants with a documented history or a current diagnosis of a thromboembolic event(s) (eg, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident, transient ischemic attack) or coagulopathy within 12 months before Screening.
  9. * Participants with severe dehydration and known blood disorders affecting viscosity.
  10. * Participants with aspartate aminotransferase and alanine aminotransferase concentration \> 3 times the upper limit of normal (ULN; central laboratory) at Screening.
  11. * Participants with creatinine concentration \> 1.5 times the ULN (central laboratory) at Screening.
  12. * Participants with new onset or worsening or severe cardiac, pulmonary, kidney disease, and liver disease.
  13. * Participants with malignancies of lymphoid cells such as chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma.

Contacts and Locations

Study Contact

Trial Registration Coordinator
CONTACT
+1 610-878-4697
clinicaltrials@cslbehring.com

Principal Investigator

Study Director
STUDY_DIRECTOR
CSL Behring

Study Locations (Sites)

84000890 - Research Solutions of AZ
Litchfield Park, Arizona, 85340
United States
84000910 - Immunoe Health Centers
Centennial, Colorado, 80112
United States
84000918 - Midwest Immunology
Plymouth, Minnesota, 55446
United States
84000885 - Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
United States
84000884 - Allergy & Clinical Immunology
Pittsburgh, Pennsylvania, 15241
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15
Study Completion Date2026-05-04

Study Record Updates

Study Start Date2025-07-15
Study Completion Date2026-05-04

Terms related to this study

Keywords Provided by Researchers

  • Immunoglobulin replacement therapy

Additional Relevant MeSH Terms

  • Primary Immunodeficiency