Takeda's Response to COVID-19 If you were diagnosed with COVID-19 and have recovered, you may be able to help in furthering research into a potential therapy for others by donating your plasma.

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

IDENTIFIERS
Trial Protocol: 091501
Clinicaltrials.gov: NCT02764489
PURPOSE

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

Recruiting
HR
MK
UA

Trial at a glance

What medical condition is being studied?   Hemophilia A or B With Inhibitors
What is the trial testing?   FEIBA
Are placebos part of the trial?   No
How many participants are being enrolled?   32
When is the trial being conducted?    - 
How long is participation in the trial?   The participation period is approximately 6 to 11 weeks from enrollment to participant completion (i.e., last study visit), unless prematurely discontinued.

Key requirements

Sex   
All
Age   
18 - 65 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

CLICK TO EXPANDCLICK TO COLLAPSE
Trial phase:   Phase 3
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
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.
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.
Intervention:   FEIBA
Primary Outcome Measure(s):   
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 Adverse Events (AEs) Related to Hypersensitivity Reactions [Time Frame: Throughout the study period of approximately 13 months]
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 Adverse Events (AEs) Related to Infusion Site Reactions [Time Frame: Throughout the study period of approximately 13 months]
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) Related to Change in Vital Signs [Time Frame: Throughout the study period of approximately 13 months]
Number of Participants With Adverse Events (AEs) Related to Change in Laboratory Assessments [Time Frame: Throughout the study period of approximately 13 months]
Entry Criteria:
Inclusion Criteria: 1. ≥ 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 (≥ 0.6 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 ≥ 200 cell/mm^3 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. 8. If female of non-childbearing potential, confirmed at screening. 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 < 100,000/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. 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. 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. 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

Trial Locations

Any
Recruiting
Any
RESULTS
University Hospital Center Zagreb

Kišpatićeva ul. 12, 10000, Zagreb, Croatia

Recruiting
4,140 miles (6,663 km)  awayfrom
Massachusetts, United States
View on Map
PHI Institute for Transfusion Medicine of Macedonia

Macedonia 1000, Skopje 1000, North Macedonia

Recruiting
4,511 miles (7,260 km)  awayfrom
Massachusetts, United States
View on Map
MV Sklifosovskyi Poltava Hematology

Shevchenka St, Poltava, Poltavs'ka oblast, Ukraine, 36000

Recruiting
4,691 miles (7,549 km)  awayfrom
Massachusetts, United States
View on Map
View all (3)
Trial Protocol ID: 091501
Back to Trial Summary