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The Trauma and Prothrombin Complex Concentrate (TAP) study is a clinical
research study for injured people who require a large-volume blood transfusion.


TAP is now enrolling patients.






ABOUT THE TAP STUDY



Thank you for your interest in the TAP study.

The TAP study (alternatively called BE1116_3006) is a clinical study of an
investigational product called BE1116. BE1116 is a 4-Factor Prothrombin Complex
Concentrate (4F-PCC) and is known by its trade names, Kcentra® (US) and
Beriplex® (outside the US).

Kcentra®/Beriplex® is approved for use to stop or prevent bleeding in some
countries but is not specifically approved to treat trauma related bleeding. For
that reason, Kcentra®/Beriplex® is an investigational product for this study.
The TAP study is a Phase 3 study, which means that the study tests the safety of
the treatment and how well it works in a large number of participants.

The TAP study is now enrolling patients who have experienced a traumatic injury
with acute major bleeding and are predicted to receive a large-volume blood
product transfusion.

Trauma is the leading cause of death in those under the age of 45. The most
common cause of preventable death after injury is bleeding, which is often
accompanied by clotting factor abnormalities. This means that people’s bodies
have a hard time stopping the bleeding.

Some people suffer fatal hemorrhages even with the current best treatment to
stop bleeding. This is why CSL Behring is evaluating the investigational
product. Kcentra®/Beriplex® contains clotting factors and anticoagulants, and
may thus be helpful in patients who have suffered a traumatic injury and acute
major bleeding as it promotes clot formation.

The purpose of the TAP study is to assess how well a single IV infusion of the
investigational product works in helping control or stop bleeding in people with
an injury who require a blood transfusion to save their life, with the overall
goal of improving survival chances for all such people.

The study will compare the health of patients who receive the investigational
product with those who receive placebo, a substance that looks like the
investigational product but has no medicinally active ingredients. All patients,
whether on the investigational product or placebo, will receive the current best
standard of care available at their hospital.

Because the investigational product must be administered quickly and because
most patients cannot consent to a study soon after a serious injury, they may be
enrolled without their consent.

The study will involve patients aged 15 years and older (≥ 16 in the UK and ≥ 18
in Australia) and they must also weigh 50 kg (110 lbs) or more.


Study participation may last up to 30 days.

Up to 8000 study patients will take part in the study.

The study will take place in approximately 120 study centers around the world.


THE FOLLOWING VIDEO PROVIDES MORE INFORMATION ABOUT THE EXCEPTIONS FROM INFORMED
CONSENT.

Exception from Informed Consent Studies (US Only)



In the USA, community disclosure and consultation is required for Exception from
Informed Consent (EFIC) studies. The University of Alabama is conducting
required EFIC activities for the TAP study.

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PARTICIPATING STUDY CENTERS

Please use the map to see other study centers participating in TAP.


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YOUR TAP JOURNEY

Your participation in the TAP study may last up to 30 days and consists of the
following.

Screening Period


The purpose of the Screening period is to ensure that you are eligible to take
part in the study.

Informed consent will usually not be possible in this period, due to the
emergency setting, and therefore most study patient enrollments will fall under
applicable emergency setting exceptions to the informed consent requirement.
However, attempts to collect informed consent will be made, if feasible, in line
with applicable law, regulations, and Institutional Review Board (IRB) or Ethics
Committee guidance.

Study Treatment Period


If you are eligible to take part in the study, you might be enrolled and
progress to the Study Treatment period. There are two study treatment groups in
this study:

 * Kcentra®/Beriplex® (BE1116) (4-Factor Prothrombin Complex Concentrate)
 * Placebo

Your study treatment group will be selected at random by a computer. You have a
one-in-two chance of receiving either Kcentra®/Beriplex® or placebo. Half of the
patients enrolled will receive Kcentra®/Beriplex® and half will receive placebo.
You will only receive one study treatment.

The study is double-blinded, which means that for the entire study, neither you
nor the study doctors will know if you have received Kcentra®/Beriplex® or
placebo. The placebo looks exactly like Kcentra®/Beriplex® but does not contain
any medicinally active drug.

Follow-Up Period


This period includes a Follow-Up period, where the study team will review your
medical records for up to 30 days after your dose of study treatment
(Kcentra®/Beriplex® or placebo). The purpose of the Follow-Up period is to
assess your health and well-being. The Follow-Up period ends when you leave the
hospital.


MEET THE STUDY TEAM




CSL BEHRING STUDY TEAM


BRAHM GOLDSTEIN

MCR, MD (USA)
VP, R&D Hematology and Thrombosis


STEVEN SLOAN

MD, PhD (USA)
Clinical Program Director, Hematology


AMY SUEN

Pharm.D. (USA)
Principal Clinical Scientist, Hematology


JEREMY CASEY

(USA)
Asset Lead, Clinical Portfolio Execution


JULIA DELFS

(GER)
Clinical Program Manager, Clinical Portfolio Execution


JAY RICHWOOD

(USA)
Clinical Program Manager, Clinical Portfolio Execution


UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB) CENTER FOR INJURY SCIENCE TEAM


JAN JANSEN, MBBS, PHD

Principal Investigator
Professor, Division of Trauma & Acute Care Surgery
Director, Center for Injury Science
University of Alabama at Birmingham


JOHN HOLCOMB, MD

Principal Investigator
Professor, Division of Trauma & Acute Care Surgery
Senior Scientist, Center for Injury Science
University of Alabama at Birmingham


BELLAL JOSEPH, MD

Principal Investigator
Martin Gluck Professor of Surgery & Vice Chairman, Research
University of Arizona
Adjunct Scientist, Center for Injury Science, UAB


SHANNON STEPHENS, CCEMTP

Program Director
Executive Director, Center for Injury Science
University of Alabama at Birmingham


KAREN BROWN, MS

Regulatory Manager
Center for Injury Science
University of Alabama at Birmingham


SARAH DUCKERT, MD

Social Media Manager
Center for Injury Science
University of Alabama at Birmingham


TANNER COFFMAN, MD

Web Content Coordinator
Center for Injury Science
University of Alabama at Birmingham


FAQS



WHAT IS A CLINICAL RESEARCH STUDY?

A clinical research study is a medical research study involving human
participants. It tests the use of a medical procedure, medical device, drug, or
other potential treatment, and is led by researchers including study doctors.
Clinical studies provide valuable information and may help researchers to
understand a condition better and learn how best to treat it, or may lead to
new, better treatments.

An investigational product must pass three phases of clinical testing before it
is approved by a country’s regulatory authority and made available to the
public. The TAP study is a Phase 3 study. In this phase, researchers test the
safety and effectiveness of an investigational product in a larger group of
patients.

WHAT IS THE PURPOSE OF THIS STUDY?

The purpose of TAP is to assess how well a single IV infusion of
Kcentra®/Beriplex® works to improve survival in patients who have suffered a
traumatic injury with acute major bleeding. Some people still suffer fatal
bleeding even with the current best therapy to stop bleeding.

WHAT IS KCENTRA®/BERIPLEX®?

Kcentra®/Beriplex® (4-Factor Prothrombin Complex Concentrate) is a blood
clotting factor replacement product. It contains clotting factors II, VII, IX,
and X, as well as Protein C and Protein S. Kcentra® is a Food and Drug
Administration (FDA) approved product. It is currently approved to reverse the
effects of drugs given to “thin” the blood in patients who are experiencing
bleeding and/or require surgery. Beriplex® is approved for use in other
countries, including the United Kingdom and Australia, when prothrombin complex
coagulation factors are deficient.

Kcentra®/Beriplex® is also known as BE1116. BE1116 is a research/experimental
medicine (i.e. investigational product) in this study because it has not been
approved to treat patients whose injuries require blood transfusion to help
control or stop bleeding and are at high risk of dying.

WHO CAN TAKE PART?

Anyone who has experienced a traumatic injury and meets the following criteria
can take part in the study:

 * Is at least 15 years old (≥ 16 in the UK and ≥ 18 in Australia)

 * Weighs at least 50 kg (110 llbs)

 * Arrives at a trauma center directly from the scene of an accident

 * Requires a blood transfusion and massive transfusion protocol activation

 * Is deemed to have acute major bleeding

HOW WILL THE STUDY TREATMENT BE GIVEN?

The study treatment (Kcentra®/Beriplex® or placebo) will be given as an
intravenous (into a vein) infusion, which lasts about 10-15 minutes. The study
treatment will be given in addition to all usual care. No care will be withheld
because of the research study.

WHAT HAPPENS AFTER THE INFUSION HAS BEEN COMPLETED?

There are no other research treatments after the infusion has been completed.
The patients will be carefully monitored for complications. There are no
additional hospital or clinic visits for this research study. After the infusion
has been completed, all information will be recorded from the patient’s medical
records.

WILL ALL PATIENTS RECEIVE KCENTRA®/BERIPLEX®?

No. In order to be able to determine whether the investigational product,
Kcentra®/Beriplex®, makes a difference, it will be given to half of the
patients. The other half will receive a placebo. When an injured patient arrives
at the hospital and is deemed to meet the criteria for participation in the TAP
study, doctors will open a special pack. The pack will contain either
Kcentra®/Beriplex® or placebo. The medical team looking after the patient will
not know which of the two the patient received. This will allow the study team
to evaluate the results in an unbiased way.

WHAT ABOUT SIDE EFFECTS?

All medications, both those that are approved and those undergoing clinical
studies, may potentially cause side effects – some of these are known, but there
could be others that have not previously been observed. Study procedures may
also involve risks.

The informed consent form that patients and/or their legally authorized
representative complete (prior to enrollment or after enrollment for continued
participation) will describe/detail any known risks. If any further risks are
discovered while the study is ongoing, you will be informed immediately if those
risks may impact you.

WHAT IS A “PLACEBO”?

If you are enrolled in the study, you will be randomly assigned by a computer to
receive either Kcentra®/Beriplex® or placebo. The placebo looks exactly like
Kcentra®/Beriplex® but does not contain any medicinally active drug. Placebos
are commonly used in clinical studies to help understand if the drug being
researched is effective. In this study, half of the patients will take the
placebo. Neither you nor the study doctor or nurses will know if you are
receiving Kcentra®/Beriplex® or placebo. In the case of an emergency, it is
possible for the study doctor to obtain this information.

WHAT HAPPENS IF I DECIDE THAT I DON'T WANT TO STAY IN THE STUDY?

You are free to leave the study at any time, and this will not affect your
future care in any way. Data collected prior to your withdrawal will still be
used for the purposes of research in accordance with applicable law.

WHAT HOSPITALS CAN TAKE PART?

Level I and II trauma centers (in the United States) or equivalent institutions
(in other countries) can take part in this study.

WHAT IS EMERGENCY CARE RESEARCH?

If a person needs urgent treatment but their condition renders them unable to
give informed consent, emergency research or research without consent may be
started so that the person is still able to receive the required treatment. The
study will attempt to obtain consent as soon as possible. In the US, this is
known as Exceptions from Informed Consent Research.

OVERSIGHT OF THE TAP STUDY

The study has been approved by the health authorities, such as the Food and Drug
Administration (FDA), in all countries that are participating. In addition, an
Independent Data Monitoring Committee will review relevant data as the study
progresses and recommend changes or even discontinuation of the study if
significant problems arise.

WHAT IS EXCEPTION FROM INFORMED CONSENT RESEARCH (EFIC) (US ONLY)?

Acute care research is sometimes conducted under Exception from Informed Consent
(EFIC) regulations in the United States. In many life-threatening illnesses,
patients are unconscious or too sick to provide written or verbal informed
consent. The federal EFIC rules were developed in 1996 to allow for the waiver
of obtaining and documenting informed consent for a strictly limited class of
research.

Research carried out under EFIC rules undergoes extremely high levels of
scrutiny by multiple agencies to assure that research subjects are afforded
every protection available under the law. Research conducted under EFIC rules
encompasses research that could not otherwise be conducted because of the nature
of illness or injury. Research carried out under EFIC must hold the promise of a
new treatment that is at least equal to or better than what is currently
available.

According to FDA regulations, to qualify for EFIC, the research study must
involve participants suffering from a life-threatening disease process or injury
for which the current standard of care is associated with a very high failure or
mortality rate. In addition, there must be reasonable evidence that the research
has the potential to provide real and direct benefit to the patient. Studies
must be held to the highest ethical standards.

The use of a randomized clinical study such as this is the “gold standard” for
determining what works best for people. For treatments that must be given
immediately to be effective, EFIC research is considered appropriate by federal
regulatory bodies and many ethicists who study this field. The obligation to
improve standard treatments that yield poor results in life-threatening
conditions is also considered an ethical imperative, as is maintaining
individual rights of citizens. In EFIC studies, citizens receive standard
treatment in addition to research treatment. To be tested in this fashion, the
research treatment has to have shown promise in earlier or smaller studies.

Before any EFIC studies are started, the US government requires that
participating institutions conduct a process of “Community Consultation and
Public Disclosure.” During this process, the study is advertised in communities
where the research will take place. Community members are invited to give their
own thoughts and comments about the proposed study. The results of these
interactions are reported to the Institutional Review Board (IRB) monitoring the
research.

Additional information is available at the EFIC website of the US Food and Drug
Administration and the Code of Federal Regulations.

COMMUNITY CONSULTATION & PUBLIC DISCLOSURE (US ONLY)

In the US, public disclosures will be performed both prior to study enrollment
and at the completion of the study in the form of multimedia press releases
organized by CSL Behring. Local sites may also decide to target notification to
specific community groups. In the event that the press releases are not widely
circulated, advertisements will also be placed on the study website used in the
social media campaigns.

OPT-OUT BRACELET (US ONLY)

If a person in the US does not want to participate in the TAP study, there is an
option for them to receive an opt-out bracelet, which, if worn at the time of
hospital admission, would exclude them from participating in the study.


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