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FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)

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ClinicalTrials.gov Identifier: NCT02764489
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Baxalta Innovations GmbH, now part of Shire
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief Summary:

The purpose of this study is to:

  • 1. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min
  • 2. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume

Condition or disease Intervention/treatment Phase
Hemophilia A or B With Inhibitors Biological: FEIBA Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b/4, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patients With Hemophilia A or B With Inhibitors
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia
Drug Information available for: FEIBA

Arm Intervention/treatment
Experimental: Part 1 Regular then reduced volume Part 2 Faster infusion rate
STUDY PART 1- FEIBA reconstituted in regular volume then FEIBA reconstituted in 50% reduced volume; STUDY PART 2- Infusion rate escalation to 4 U/min/kg and reconstituted in 50% reduced volume; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 4 U/min/kg; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 10 U/min/kg
Biological: FEIBA
Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA NF.
Other Names:
  • FEIBA NF.
  • AICC
  • anti-inhibitor coagulant complex
  • Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC])
  • APCC
  • Activated prothrombin complex concentrate

Experimental: Part 1 Reduced then regular volume Part 2 Faster infusion rate
STUDY PART 1- FEIBA Reconstituted in 50% Reduced Volume then FEIBA Reconstituted in Regular Volume; STUDY PART 2- Infusion rate escalation to 4 U/min/kg and reconstituted in 50% reduced volume; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 4 U/min/kg; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 10 U/min/kg
Biological: FEIBA
Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA NF.
Other Names:
  • FEIBA NF.
  • AICC
  • anti-inhibitor coagulant complex
  • Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC])
  • APCC
  • Activated prothrombin complex concentrate




Primary Outcome Measures :
  1. Participants experiencing serious adverse events (SAEs) and non-SAEs [ Time Frame: Throughout the study period of approximately 20months ]
    Number of participants experiencing serious adverse events (SAEs) and non-SAEs

  2. Participants experiencing adverse events (AEs) leading to discontinuation [ Time Frame: Throughout the study period of approximately 20 months ]
    Number of participants experiencing adverse events (AEs) leading to discontinuation

  3. Participants experiencing thromboembolic events [ Time Frame: Throughout the study period of approximately 20 months ]
    Number of participants experiencing thromboembolic events

  4. Participants experiencing allergic-type hypersensitivity reactions [ Time Frame: Throughout the study period of approximately 20 months ]
    Number of participants experiencing allergic-type hypersensitivity reactions

  5. Clinically significant changes in vital signs [ Time Frame: Prior to infusion and post-infusion at 30 minutes ]
    Number of clinically significant changes in vital signs

  6. Clinically significant changes in clinical laboratory assessments [ Time Frame: Screening visit and the study completion/ termination visit (up to approximately week 11) ]
    Number of clinically significant changes in clinical laboratory assessments

  7. Clinically significant changes in coagulation assessments [ Time Frame: Within 60 minutes prior to infusion and post-infusion at 6 timepoints up to 12 hours for 6 infusions ]
    Number of clinically significant changes in coagulation assessments

  8. Participants experiencing infusion site/ infusion related reactions - immediate reactions up to 30 minutes after infusion [ Time Frame: Up to 30 minutes after infusion ]
    Number of participants experiencing infusion site reactions/ infusion related reactions

  9. Participants experiencing infusion site/ infusion related reactions - non-immediate reactions monitored by the participant after 30 minutes up to 12 hours after infusion [ Time Frame: After the 30 minute immediate local reaction assessment, up to 12 hours after infusion ]
    Number of participants experiencing infusion site reactions/ infusion related reactions



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is ≥ 18 to ≤ 65 years old at the time of screening
  2. Hemophilia A or B of any severity, with a documented >3 months history of inhibitors requiring the use of bypassing agents (FEIBA or rFVIIa)
  3. HCV negative; or HCV positive with stable hepatic disease
  4. HIV negative; or HIV positive with stable disease and CD4 count ≥ 200 cell/mm^3 at screening
  5. Adequate peripheral venous access
  6. Participant is willing and able to comply with the requirements of the protocol
  7. If a female of childbearing potential, participant must have a negative blood pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
  8. If female of non-childbearing potential, must be confirmed at screening.

Exclusion Criteria:

  1. Known hypersensitivity to FEIBA or any of its components
  2. Clinically symptomatic liver disease.
  3. Planned elective surgery during participation in this study (excluding minor procedures that will not need preventative bleeding treatments, such as exchanges of peripherally inserted central catheters)
  4. Platelet count < 100,000/μL
  5. Clinical or laboratory evidence of disseminated intravascular coagulation
  6. Prior history or evidence of thromboembolic event: acute myocardial infarction, deep vein thrombosis, pulmonary embolism, etc.
  7. Diagnosis of advanced atherosclerosis, malignancy, and/or other diseases that may increase the participant's risk of thromboembolic complications
  8. Participant is taking any immunomodulating drug (e.g., corticosteroid agents at a dose equivalent to hydrocortisone > 10 mg/day, or α-interferon) within 30 days prior to enrollment except anti-retroviral chemotherapy
  9. Herbal supplements that contain anti-platelet activity
  10. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
  11. Participant is a family member or employee of the investigator
  12. Clinically significant medical, psychiatric or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance

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): NCT02764489


Contacts
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Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

Locations
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Croatia
University Hospital Center Zagreb Recruiting
Zagreb, Croatia, 10 000
Contact: Site Contact    + 385 98 3199 21    silva.zupancic-salek@zg.htnet.hr   
Principal Investigator: Silva Zupančić Šalek, MD, PhD         
Ukraine
MV Sklifosovskyi Poltava Hematology Recruiting
Poltava, Ukraine, 36011
Contact: Site Contact    380662179414    inskrypnyk@gmail.com   
Principal Investigator: Igor Skrypnyk         
Sponsors and Collaborators
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire
Investigators
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Study Director: Study Director Shire

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02764489     History of Changes
Other Study ID Numbers: 091501
2015-005781-39 ( EudraCT Number )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.

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

Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Thrombin
Anti-inhibitor coagulant complex
Coagulants
Hemostatics