About ELEVATE Study

About ELEVATE Study:


The purpose of this Phase III clinical study is to assess the ability of eltrombopag to elevate platelet counts to a level sufficient to reduce the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures.

Eltrombopag is an investigational drug in this setting. As you are aware, thrombocytopenia is common amongst people with chronic liver disease, and a platelet transfusion is often required to avoid excessive bleeding in these patients when they are undergoing an invasive procedure.

We are aiming to enroll up to 500 adults in this clinical study which is taking place at research centers across the US and currently another 17 countries worldwide. We have already started recruiting patients and we anticipate that the clinical study will continue to enrol until the end of the year.


S. Marc Meachem, Product Communications , GlaxoSmithKline - A3150B
919.483.8756
marc.s.meachem@gsk.com


Do you have chronic liver disease and a low platelet level? Do you need to have an invasive medical or dental procedure? If so, you may be eligible to participate in a clinical study called ELEVATE (ELtrombopag EValuated for its Ability to overcome Thrombocytopenia and Enable procedures).

A low level of platelets in the blood, also known as thrombocytopenia, is common amongst people with chronic liver disease. Platelets, or thrombocytes, are a specific kind of blood cell that helps the blood to clot. They stop or prevent excessive bleeding. A low platelet level can be serious, especially if you need to undergo invasive surgery or a dental procedure for example. To help avoid excessive bleeding during this type of procedure, people with thrombocytopenia usually receive a platelet transfusion in order to increase the level of platelets in their blood. These are usually given by drip (infusion) as an outpatient procedure.

The ELEVATE study will test whether a drug called ‘eltrombopag’ works at raising platelet levels in people with chronic liver disease and thrombocytopenia. The goal of the study is to assess whether the use of this eltrombopag treatment can eliminate the need for you to receive this platelet transfusion.

You may be eligible to take part in the ELEVATE study and help in the development of this treatment, so here are a few more details about the study.

Who qualifies for this study?

We would like to enroll up to 500 adults in the ELEVATE study, at research centers here in the US and other countries worldwide. Below are some of the criteria you must meet in order to be eligible to participate:

· At least 18 years old

· Diagnosed with chronic liver disease and have a low platelet count

· Candidate for an elective invasive procedure and will require a platelet transfusion to manage the risk of bleeding associated with the procedure

· Not currently pregnant or nursing

Additional test results and health information will be needed by research staff to confirm your eligibility.

What can you expect as a study participant?

If you are eligible and you decide to participate in this clinical study, you will be asked to sign a consent form. You will undergo a medical history review, physical exam, and various laboratory tests (blood and urine) to confirm your eligibility. If you decide to participate in the study, you will then be asked to:

· Take the study medication by mouth once a day for 14 days prior to your invasive procedure

· Return to the clinic once a week for 4 weeks after the procedure for follow-up exams, including platelet counts and other laboratory tests

· All study-related medical exams, laboratory tests, and study medication will be provided to study participants at no cost.



If you are eligible and decide to participate in this study, you can withdraw from the study at any time.

If you would like to learn more about the ELEVATE study:

Please talk to your physician about enrolling on this study, contact the US GSK Clinical Trials Center at 1 877-379-3718] or go to www.clinicaltrials.gov and then search for: NCT00678587.



Who qualifies for this study?

Up to 500 adults will be enrolled in the ELEVATE study

at research centers worldwide. Below are some of the

criteria you must meet in order to be eligible to participate

in this study.

• At least 18 years old

• Diagnosed with chronic liver disease

• Candidate for an elective invasive procedure

and require a platelet transfusion to manage the

risk of bleeding associated with the procedure

• Not currently pregnant or nursing

Additional test results and health information will be

needed by research staff to confi rm your eligibility.



What can you expect as a study participant?

If you are eligible and you decide to participate in this

clinical trial, you will be asked to sign a consent form.

You will undergo a medical history review, physical exam,

and laboratory tests (blood and urine) to confi rm your

eligibility. During this study, you will be asked to:

• Take the study medication by mouth once a day

for 14 days prior to your invasive procedure

• Return to the clinic once a week for 4 weeks for

follow-up exams, including platelet counts and

other laboratory tests

All study-related medical exams, laboratory tests, and

study medication will be provided to study participants

at no cost. Your participation in this study is voluntary

and you can withdraw from the study at any time.



To learn more about the ELEVATE study:

Contact your physician or the US GSK Clinical Trials

Call Center at 1-877-379-3718, or go to

www.clinicaltrials.gov and then search for TPL104054.