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Factor Viii Inhibitor Bypassing Fraction

This article explores clinical trials investigating the use of Factor VIII Inhibitor Bypassing Fraction, also known as FEIBA, in various medical conditions. FEIBA is primarily studied in patients with hemophilia A who have developed inhibitors to factor VIII, as well as in cardiac surgery settings. The trials aim to evaluate FEIBA’s effectiveness in controlling bleeding, reducing the need for blood transfusions, and its safety profile when used alone or in combination with other treatments.

Table of Contents

What is FEIBA?

FEIBA, which stands for Factor Eight Inhibitor Bypassing Activity, is a medication used to treat certain bleeding disorders. It’s also known as activated prothrombin complex concentrate (aPCC) or Anti-Inhibitor Coagulant Complex[1][2]. FEIBA contains several blood clotting factors that work together to help your blood clot properly when you’re bleeding.

What Conditions Does FEIBA Treat?

FEIBA is primarily used to treat and prevent bleeding in people with the following conditions:

  • Hemophilia A with inhibitors: This is a rare but serious complication in some people with hemophilia A (a genetic disorder that affects blood clotting). In this condition, the body develops antibodies (inhibitors) that neutralize the clotting factor VIII that’s used to treat hemophilia A[1][3].
  • Hemophilia B with inhibitors: Similar to hemophilia A with inhibitors, but involving factor IX[3].
  • Other congenital bleeding disorders: FEIBA may also be used in other rare bleeding disorders where normal blood clotting is impaired[3].

How Does FEIBA Work?

FEIBA works by “bypassing” the need for the clotting factors that are missing or not working properly in people with hemophilia and inhibitors. It contains activated clotting factors that can help form a blood clot even when the usual clotting process is disrupted by inhibitors[4]. This makes it an effective treatment for bleeding episodes in people who have developed inhibitors to standard factor replacement therapy.

Usage and Dosage

FEIBA is typically administered intravenously (through a vein). The dosage and frequency of administration can vary depending on several factors, including:

  • The severity and location of the bleeding
  • The patient’s body weight
  • The specific condition being treated

In some studies, FEIBA has been used in the following ways:

  • For treating acute bleeding episodes: Doses ranging from 25 U/kg to 100 U/kg, with frequency depending on the response[2][5].
  • For prevention of bleeding (prophylaxis): 85 U/kg (±15%) given on three non-consecutive days each week[5].

Always follow your doctor’s instructions regarding dosage and administration of FEIBA.

Clinical Studies and Effectiveness

Several clinical studies have investigated the effectiveness of FEIBA:

  • A study compared FEIBA to another bypassing agent (NovoSeven) for treating joint bleeds in hemophilia patients with inhibitors. The study aimed to compare the effectiveness of these treatments after 6 hours[6].
  • Another study looked at using FEIBA for preventing bleeds in hemophilia A patients with inhibitors. This study compared regular preventive use of FEIBA to on-demand treatment[5].
  • A pilot study investigated the use of FEIBA in cardiac surgery patients to reduce the need for blood transfusions[4].

These studies generally found FEIBA to be effective in treating and preventing bleeding episodes in patients with hemophilia and inhibitors.

Safety and Side Effects

While FEIBA is generally considered safe when used as directed, it can have side effects. Some potential risks include:

  • Thrombotic events: In rare cases, FEIBA can cause blood clots to form where they shouldn’t. This risk may be higher when FEIBA is used in combination with other clotting agents[2].
  • Allergic reactions: As with any medication, some people may have an allergic reaction to FEIBA.
  • Other side effects: These may include headache, fever, or changes in blood pressure.

Your doctor will monitor you closely for any side effects when you’re using FEIBA.

Comparison with Other Treatments

FEIBA is one of several “bypassing agents” used to treat bleeding in hemophilia patients with inhibitors. Another commonly used bypassing agent is recombinant factor VIIa (rFVIIa), also known as NovoSeven[6][7]. Some key points about how FEIBA compares to other treatments:

  • Both FEIBA and rFVIIa are considered effective for treating bleeds in patients with inhibitors.
  • Some studies have directly compared FEIBA and rFVIIa to see if one is more effective than the other for certain types of bleeds[6].
  • The choice between FEIBA and other treatments often depends on individual patient factors and response to treatment.
  • In some cases, FEIBA and other treatments may be used in combination, although this requires careful monitoring due to the potential risk of blood clots[1].

Your healthcare provider will work with you to determine the best treatment plan for your specific situation.

Aspect Details
Primary Conditions Studied Hemophilia A with inhibitors, Cardiac surgery patients
Main Objectives Evaluate FEIBA’s effectiveness in controlling bleeding, Assess safety profile, Reduce need for blood transfusions
Key Outcome Measures Hemostatic efficacy, Number of blood product units transfused, Occurrence of adverse events (especially thrombotic)
Dosing Strategies Various dosing regimens explored, including combination with other agents like rFVIIa
Patient Populations Adults and children with hemophilia A and inhibitors, Cardiac surgery patients (both adult and pediatric)
Comparative Studies FEIBA vs. NovoSeven (rFVIIa), FEIBA vs. Placebo in cardiac surgery
Novel Approaches Combination therapy with low doses of FEIBA and rFVIIa, Use with emicizumab
Quality of Life Assessments Impact of bleeding episodes and treatment on daily activities and patient/caregiver quality of life

FAQ

  • What is FEIBA and what is it used for? FEIBA stands for Factor VIII Inhibitor Bypassing Activity. It is a medication used primarily in patients with hemophilia A who have developed inhibitors to factor VIII. FEIBA helps to control and prevent bleeding episodes in these patients by bypassing the need for factor VIII in the clotting process.
  • How is FEIBA being studied in cardiac surgery? FEIBA is being investigated in cardiac surgery to potentially reduce the need for blood transfusions after cardiopulmonary bypass. Some trials are exploring its use in both adult and pediatric patients undergoing cardiac procedures to see if it can improve blood clotting and decrease postoperative bleeding.
  • Are there any risks associated with using FEIBA? As with any medication, there are potential risks. In the clinical trials, researchers are closely monitoring for adverse events, particularly thrombotic (blood clotting) complications. The studies aim to determine the safest and most effective dosing regimens to minimize risks while maximizing benefits.
  • How is FEIBA being studied in combination with other treatments? Some trials are investigating the combination of FEIBA with other medications, such as recombinant factor VIIa (rFVIIa) or emicizumab. These studies aim to find optimal treatment strategies for patients with hemophilia and inhibitors who may not respond well to single-agent therapy.
  • What are the main outcomes being measured in these FEIBA trials? The main outcomes being measured include the effectiveness in controlling bleeding episodes, the amount of blood products required for transfusion, safety profiles (including thrombotic events), and in some cases, the impact on patients' quality of life. Some studies also look at hospital length of stay and overall treatment costs.

Ongoing Clinical Trials on Factor Viii Inhibitor Bypassing Fraction

  • Study on the Safety and Effectiveness of Emicizumab for Patients with Type 3 Von Willebrand Disease

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Poland +2

  • Study on Emicizumab and Drug Combination for Patients with Haemophilia A and FVIII Inhibitors

    Recruiting

    1 1 1 1
    Investigated drugs:
    Bulgaria Croatia Finland Germany Norway Spain +1

  • Study of Long-term Safety and Efficacy of Fitusiran in Patients with Hemophilia A or B with or without Inhibitory Antibodies to Factor VIII or IX

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Denmark France Hungary Ireland Italy

  • Study on Fitusiran for Preventing Bleeding in Males Aged 12 and Older with Severe Hemophilia A or B, with or without Inhibitors

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Germany Greece Italy Poland Spain

Glossary

  • Factor VIII: A crucial protein in the blood clotting process that is deficient in people with hemophilia A.
  • Inhibitors: Antibodies that the immune system develops against treatment factors, making them less effective or ineffective in controlling bleeding.
  • Hemophilia A: A genetic bleeding disorder characterized by a deficiency of clotting factor VIII.
  • Cardiopulmonary bypass: A technique used in cardiac surgery where a machine temporarily takes over the function of the heart and lungs during the operation.
  • Thrombin generation: A laboratory test that measures the ability of blood to form clots.
  • Coagulopathy: A condition in which the blood's ability to form clots is impaired.
  • Prophylaxis: Preventive treatment to stop or reduce the frequency of bleeding episodes.
  • Recombinant factor VIIa (rFVIIa): A synthetic version of a clotting factor used to treat bleeding in certain types of hemophilia.
  • Emicizumab: A medication used to prevent or reduce the frequency of bleeding in people with hemophilia A.
  • Thrombotic microangiopathy (TMA): A rare but serious condition characterized by blood clots in small blood vessels throughout the body.

References

  1. https://clinicaltrials.gov/study/NCT00284193
  2. https://clinicaltrials.gov/study/NCT04563520
  3. https://clinicaltrials.gov/study/NCT00710619
  4. https://clinicaltrials.gov/study/NCT02577614
  5. https://clinicaltrials.gov/study/NCT00221195
  6. https://clinicaltrials.gov/study/NCT00166309
  7. https://clinicaltrials.gov/study/NCT00108797