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Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810444
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Biotest

Brief Summary:
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)

Condition or disease Intervention/treatment Phase
Immunodeficiency Primary Biological: BT595 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)
Study Start Date : October 2016
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020


Arm Intervention/treatment
Experimental: BT595
Patients will receive BT595 according to their usual regime treatment every 3 or 4 weeks
Biological: BT595
Other Name: Human Immunoglobulin




Primary Outcome Measures :
  1. Rate of acute serious bacterial infections [ Time Frame: 1 year ]
    The rate of acute serious bacterial infections (i.e., the mean number of acute serious bacterial infections per subject-year) is less than 1.0 to provide substantial evidence of efficacy.


Secondary Outcome Measures :
  1. IgG trough levels (total IgG) before each infusion [ Time Frame: 1 year ]
  2. Rate of any infections (number per year) [ Time Frame: 1 year ]
  3. Rate of nonserious infections (number per year) [ Time Frame: 1 year ]
  4. Time to resolution of infections [ Time Frame: 1 year ]
  5. Antibiotic treatment (number of days antibiotic treatment received per month [ Time Frame: 1 year ]
  6. Rate of time lost from school/work due to infections (number of days per month) [ Time Frame: 1 year ]
  7. Duration of treatment due to infections (number of days treatment per month) [ Time Frame: 1 year ]
  8. Hospitalization (number of days per month overall and due to infection) [ Time Frame: 1 year ]
  9. Fever episodes (number of days per year) [ Time Frame: 1 year ]
  10. Changes in health related quality of life Parameters, i.e. Peds QL, EQ-5D [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Written informed consent/assent obtained from subjects/subjects' parent(s) or legally acceptable representative indicating that they understand the purpose of and procedures required for the study and are willing to participate in it.
  • Male or female, aged 2 through 75 years.
  • Diagnosis of PID with impaired antibody production, i.e.:

Diagnosis of common variable immunodeficiency (CVID) as defined by the European Society for Immunodeficiencies (ESID)/Pan American Group for Immunodeficiency (PAGID) diagnostic criteria.

Or

  • X linked agammaglobulinemia (XLA) as defined by ESID/PAGID diagnostic criteria.
  • Established replacement therapy with any intravenous immunoglobulin (IVIg) reference preparation during the previous 6 months, including documentation of immunoglobulin G (IgG) trough levels.
  • Established replacement therapy with a single IVIg reference preparation for at least 3 months prior to treatment start with BT595 at a 3 or 4 week schedule with a constant IVIg dose that did not change by ±20% of the mean dose, regular dosage intervals, and at least 1 IgG trough level of ≥5 g/L during the previous 3 months.

Main Exclusion Criteria:

  • Known intolerance to immunoglobulins or comparable substances (e.g., vaccination reaction).
  • Known intolerance to proteins of human origin or known allergic reactions to components of the study product.
  • Acquired medical conditions known to cause secondary immune deficiency, such as chronic lymphatic leukemia, lymphoma, multiple myeloma, as well as protein losing enteropathies and hypoalbuminemia.
  • Recent febrile illness that precludes or delays participation.
  • Active infection and receiving antibiotic therapy for the treatment of this infection at the time of screening. Note: if the subject is deemed to be a screen failure due to a nonserious active infection requiring antibiotic therapy, the subject may be rescreened after the initial screening.
  • Therapy with systemic steroids or other immunosuppressant drugs at the time of enrollment (current daily use of corticosteroids, i.e., >10 mg prednisone equivalent/day for >30 days. Intermittent corticosteroid use during the study is allowable, if medically necessary).
  • History of thrombotic events (including myocardial infarction, cerebral vascular accident [including stroke], pulmonary embolism, and deep vein thrombosis) within the 6 months before treatment start with BT595 or the presence of significant risk factors for thrombotic events.
  • Therapy with live attenuated virus vaccines within 3 months before start of the study.
  • Selective, absolute immunoglobulin A (IgA) deficiency or known antibodies to IgA.

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): NCT02810444


Locations
Show Show 19 study locations
Sponsors and Collaborators
Biotest
Syneos Health
Investigators
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Principal Investigator: Gergely Krivan, MD Egyesitett Szent Istvan es Szent Laszlo Korhaz, Budapest, Hungary
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Responsible Party: Biotest
ClinicalTrials.gov Identifier: NCT02810444    
Other Study ID Numbers: 991
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs