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View Clinical Trial (Medical Research Study)
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Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease - NCT00516321-39202 (Clinical Trial 180219)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy180219.aspx
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| City: |
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Jackson |
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State:
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MS |
| Zip Code: |
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39202 |
| Conditions: |
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Thrombocytopenia - Hepatitis C |
| Purpose: |
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The purpose of this study is to assess the ability of eltrombopag to maintain a platelet
count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral
therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The
clinical benefit of eltrombopag will be measured by the proportion of subjects who are able
to achieve a Sustained Virological Response (SVR).
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
Male and female subjects, >18 years Evidence of chronic HCV infection Subjects who are
appropriate candidates for pegIFN and ribavirin antiviral therapy A platelet count of
<75,000/uL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count
(ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine
clearance >50mL/minute All fertile males and females must use two forms of effective
contraception between them during treatment and during the 24 weeks after treatment end
Subject is able to understand, consent and comply with protocol requirements and
instructions and is likely to complete the study as planned
Exclusion criteria:
Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a SVR
for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of
combination therapy with peginterferon and ribavirin Decompensated liver disease, e.g.
Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of
ascites Known hypersensitivity, intolerance or allergy to IFN, ribavirin, eltrombopag or
any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would
preclude treatment with pegIFN and ribavirin
Subjects with a history of any one of the following:
Suicide attempt or hospitalisation for depression in the past 5 years Any current severe
or poorly controlled psychiatric disorder The following subjects are eligible for study
participation, but must be assessed and followed (if recommended) by a mental health
professional:
- Subjects who have had a severe or poorly controlled psychiatric disorder more than 6
months ago but less than 5 years ago
- Seizure disorder that has not been well controlled History of clinically significant
bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g.
sickle cell anaemia, thalassemia major Any prior history of arterial or venous
thrombosis AND two or more of the following risk factors: hereditary thrombophilic
disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy,
systemic contraception (containing estrogen), smoking, diabetes,
hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac
disease (NYHA Grade III/IV), or arrhythmias known to involve the risk of
thromboembolic events, or QTc >450 msec Evidence of hepatocellular carcinoma
Laboratory evidence of infection with HIV or active Hepatitis B Virus (HBV) infection
Any disease condition associated with active bleeding or requiring anticoagulation
with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory
treatment <6 months prior to the first dose of eltrombopag Subjects who have had a
malignancy diagnosed and/or treated within the past 5 years, except for subjects with
localised basal or squamous cell carcinoma treated by local excision or subjects with
malignancies who have been adequately treated and, in the opinion of the oncologist,
have an excellent chance of cancer-free survival Pregnant or nursing women Males with
a female partner who is pregnant History of alcohol/drug abuse or dependence within 6
months of the study start (unless participating in a controlled rehabilitation
programme) Treatment with an investigational drug or IFN within 30 days or 5
half-lives (whichever is longer) of the screening visit History of platelet clumping
that prevents reliable measurement of platelet counts History of major organ
transplantation with an existing functional graft Thyroid dysfunction not adequately
controlled Subjects planning to have cataract surgery Evidence of portal vein
thrombosis on abdominal imaging within 3 months of the baseline visit |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 23, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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