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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02764489
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : June 17, 2020
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

Detailed Description:

15 JUN 2020: The temporary enrollment stop of new patients into this study due to the COVID-10 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new patients. However, some countries/sites may still have paused the enrollment of new patients due to the pandemic.

23 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

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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 13, 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. Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events [ Time Frame: Throughout the study period of approximately 13 months ]
    Number of participants with serious adverse events (SAEs) and non-SAEs will be assessed.

  2. Number of Participants With Adverse Events (AEs) Related to Hypersensitivity Reactions [ Time Frame: Throughout the study period of approximately 13 months ]
    Number of participants with AEs particular to allergic-type hypersensitivity reactions will be assessed.

  3. Number of Participants With Adverse Events (AEs) Related to Thromboembolic Events [ Time Frame: Throughout the study period of approximately 13 months ]
    Number of participants with AEs particular to thromboembolic events will be assessed.

  4. Number of Participants With Adverse Events (AEs) Related to Infusion Site Reactions [ Time Frame: Throughout the study period of approximately 13 months ]
    Number of participants with AEs related to infusion site reactions will be assessed.

  5. Number of Participants With Adverse Events (AEs) Leading to Discontinuation [ Time Frame: Throughout the study period of approximately 13 months ]
    Number of participants with adverse events (AEs) leading to discontinuation will be assessed.

  6. Number of Participants With Adverse Events (AEs) Related to Change in Vital Signs [ Time Frame: Throughout the study period of approximately 13 months ]
    Number of participants with AEs related to change in vital signs will be assessed. Vital signs will include body temperature (degree Celsius or degrees Fahrenheit [°C or °F]), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (millimeter of mercury [mmHg]).

  7. Number of Participants With Adverse Events (AEs) Related to Change in Laboratory Assessments [ Time Frame: Throughout the study period of approximately 13 months ]
    Number of participants with AEs related to change in laboratory assessments will be assessed. Laboratory assessments include hematology, clinical chemistry, coagulation testing, serological testing, pregnancy testing, cluster differentiation 4 (CD4).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Greater than or equal to (> or =) 18 to less than or equal to (< or =) 65 years old at the time of screening.
  2. Hemophilia A or B of any severity, with a documented > or = 3 months history of inhibitors (> or = 0.6 Bethesda units [BU]) requiring the use of bypassing agents (FEIBA or rFVIIa) prior to screening. Inhibitor level will be tested at screening if no documented history is available.
  3. Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain reaction (PCR); or HCV positive with stable liver disease.
  4. Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and CD4 count > or = 200 cells per cubic millimetre (cell/mm3) at screening.
  5. Adequate venous access.
  6. Willing and able to comply with the requirements of the protocol.
  7. If a female of childbearing potential, must have a negative blood pregnancy test and agrees to employ adequate birth control measures for the duration of the study, such as: a. Abstain from sexual intercourse, b. Use a reliable method of contraception (contraception such as an intrauterine device, barrier method [e.g., diaphragm or sponge; female condom not permitted] with spermicide, oral contraceptive, injectable progesterone, sub dermal implant), and have their male partner use a condom
  8. If female of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:

    1. Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone levels within the laboratory-defined postmenopausal range or postmenopausal with amenorrhea for at least 24 months and on hormonal replacement therapy.
    2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, bilateral tubal ligation (with no subsequent pregnancy at least 1 year from bilateral tubal ligation), or bilateral salpingectomy.

Exclusion criteria:

  1. Known hypersensitivity to FEIBA or any of its components.
  2. Advanced liver disease (e.g., liver biopsy confirmed diagnosis of cirrhosis, portal vein hypertension, ascites, prothrombin time [PT] 5 seconds above upper limit of normal).
  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 less than (<) 100,000/ microliter (μL).
  5. Taking Emicizumab (Hemlibra) for bleed prevention.
  6. Clinical or laboratory evidence of disseminated intravascular coagulation based on medical history.
  7. Prior history or evidence of thromboembolic event: acute myocardial infarction, deep vein thrombosis, pulmonary embolism, etc.
  8. Diagnosis of advanced atherosclerosis, malignancy, and/or other diseases that may increase the participant's risk of thromboembolic complications.
  9. Participant is taking any immunomodulating drug (e.g., corticosteroid agents at a dose equivalent to hydrocortisone greater than (>) 10 milligram per day (mg/day), or α-interferon) within 30 days prior to enrollment except anti-retroviral chemotherapy.
  10. Herbal supplements that contain anti-platelet activity.
  11. 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.
  12. Participant is a family member or employee of the investigator.
  13. 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         
North Macedonia
PHI Institute for Transfusion Medicine of Macedonia Recruiting
Skopje, North Macedonia, 1000
Principal Investigator: Irina Panovska Stavridis, MD         
Principal Investigator: Violeta Dejanova - Ilijevska, MD         
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    
Other Study ID Numbers: 091501
2015-005781-39 ( EudraCT Number )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

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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