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For Hector SF - ELEVATE Study
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 877-379-3718 or go to www.clinicaltrials.gov and then search for: NCT00678587.
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 877-379-3718 or go to www.clinicaltrials.gov and then search for: NCT00678587.
Thanks for the info. I am waiting for hear from my doctor at UCSF about this new drug and it's usage by cirrhotics. The drug is approved for one disease and know they are wondering if it will work for cirrhotics who can't undergo HCV treatment because of low platelet count.
It does raise platelets no doubt. The problem, issue is...
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Because of the risk for hepatotoxicity and other risks [see Warnings and Precautions (5.1-5.6)], PROMACTA is available only through a restricted distribution program called PROMACTA CARES. Under PROMACTA CARES, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive PROMACTA. To enroll in PROMACTA CARES, call 1-877-9-PROMACTA [see Warnings and Precautions (5.8)].
WARNING: RISK FOR HEPATOTOXICITY
See full prescribing information for complete boxed warning
PROMACTA may cause hepatotoxicity:
● Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.
● Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels.
● Discontinue PROMACTA if ALT levels increase to ≥3X upper limit of normal (ULN) and are:
● progressive, or
● persistent for ≥4 weeks, or
● accompanied by increased direct bilirubin, or
● accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
5.1 Risk for Hepatotoxicity
"PROMACTA administration may cause hepatotoxicity. In the controlled clinical studies, one patient experienced Grade 4 (NCI Common Terminology Criteria for Adverse Events [NCI CTCAE] toxicity scale) elevations in serum liver test values during therapy with PROMACTA, worsening of underlying cardiopulmonary disease, and death. No patients in the placebo group experienced Grade 4 liver test abnormalities. Overall, serum liver test abnormalities (predominantly Grade 2 or less in severity) were reported in 10% and 8% of the PROMACTA and placebo groups, respectively. In the controlled studies, two patients (1%) treated with PROMACTA and two patients in the placebo group (3%) discontinued treatment due to hepatobiliary laboratory abnormalities. Seven of the patients treated with PROMACTA in the controlled studies with hepatobiliary laboratory abnormalities were re-exposed to PROMACTA in the extension study. Six of these patients again experienced liver test abnormalities (predominantly Grade 1) resulting in discontinuation of PROMACTA in one patient. In the extension study, one additional patient had PROMACTA discontinued due to liver test abnormalities (≤Grade 3)."
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Anything that could cause decompensation to a compensated cirrhotic is the last thing you would want to have happen. Transplant is the only option at that point. Even though it was a very small percentage of patients who had this happen it makes me tale a wait and see approach.
Thank you for the information. I will be seeing my doctor in June and will ask her if this drug is or will be used for people like myself.
Cheers!
Hectorsf
It does raise platelets no doubt. The problem, issue is...
-----------------------------------------------------------------------------------------------------------------
Because of the risk for hepatotoxicity and other risks [see Warnings and Precautions (5.1-5.6)], PROMACTA is available only through a restricted distribution program called PROMACTA CARES. Under PROMACTA CARES, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive PROMACTA. To enroll in PROMACTA CARES, call 1-877-9-PROMACTA [see Warnings and Precautions (5.8)].
WARNING: RISK FOR HEPATOTOXICITY
See full prescribing information for complete boxed warning
PROMACTA may cause hepatotoxicity:
● Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.
● Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels.
● Discontinue PROMACTA if ALT levels increase to ≥3X upper limit of normal (ULN) and are:
● progressive, or
● persistent for ≥4 weeks, or
● accompanied by increased direct bilirubin, or
● accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
5.1 Risk for Hepatotoxicity
"PROMACTA administration may cause hepatotoxicity. In the controlled clinical studies, one patient experienced Grade 4 (NCI Common Terminology Criteria for Adverse Events [NCI CTCAE] toxicity scale) elevations in serum liver test values during therapy with PROMACTA, worsening of underlying cardiopulmonary disease, and death. No patients in the placebo group experienced Grade 4 liver test abnormalities. Overall, serum liver test abnormalities (predominantly Grade 2 or less in severity) were reported in 10% and 8% of the PROMACTA and placebo groups, respectively. In the controlled studies, two patients (1%) treated with PROMACTA and two patients in the placebo group (3%) discontinued treatment due to hepatobiliary laboratory abnormalities. Seven of the patients treated with PROMACTA in the controlled studies with hepatobiliary laboratory abnormalities were re-exposed to PROMACTA in the extension study. Six of these patients again experienced liver test abnormalities (predominantly Grade 1) resulting in discontinuation of PROMACTA in one patient. In the extension study, one additional patient had PROMACTA discontinued due to liver test abnormalities (≤Grade 3)."
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Anything that could cause decompensation to a compensated cirrhotic is the last thing you would want to have happen. Transplant is the only option at that point. Even though it was a very small percentage of patients who had this happen it makes me tale a wait and see approach.
Thank you for the information. I will be seeing my doctor in June and will ask her if this drug is or will be used for people like myself.
Cheers!
Hectorsf
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