Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2011-08-31
2014-09-30
Brief Summary
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Studies in experimental animals have shown that sorafenib may also lower portal vein pressure (the pressure of the blood passing from the intestine through the liver.) This study seeks to determine if sorafenib lowers the blood pressure in liver blood vessels (portal vein pressure) in patients with cirrhosis who have high portal vein pressure. The study will also obtain information whether sorafenib is safe in this patient population.
Half of the patients will be given sorafenib and half will be given a placebo (a pill without any medicine in it.) This allows a comparison of the reactions of people who take sorafenib to those who do not.
Detailed Description
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The primary end-point of the study is the change in HVPG observed from baseline to three months after starting treatment with sorafenib. Secondary end-point is safety of sorafenib.
The trial is structured as a randomized double blind placebo controlled study. After a three-month period of therapy with sorafenib or placebo (double-blind phase), patients will be given open-label sorafenib for an additional 3-month period (open-label phase). A total of 44 patients will be randomized (in the initial phase) on a 1:1 ratio to sorafenib or placebo. Patients will be followed monthly and HCC follow-up will be according to standards of care. The study will be sponsored by Onyx, who will also provide the treatment medication (sorafenib and placebo)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.
Placebo
Placebo Comparator: Placebo
Sorafenib
Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.
Sorafenib
Sorafenib, 400 mg twice daily
Interventions
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Placebo
Placebo Comparator: Placebo
Sorafenib
Sorafenib, 400 mg twice daily
Eligibility Criteria
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Inclusion Criteria
* Cirrhosis diagnosed by liver biopsy or by imaging studies showing a nodular liver, splenomegaly and/or collaterals
* HCC proven histologically or diagnosed following the AASLD criteria if biopsy not feasible or refused by the patient
* HCC must be unresectable and within UCSF criteria (single tumor ≤ 6.5 cm diameter, or, if multiple lesions, maximum diameter of the largest lesion ≤ 4.5 and total tumor diameter ≤ 8 cm (23))
* CPT score \<9 (that is all Child A and Child B with a score of 7 or 8)
* Complete response to treatment with RFA (including that performed laparoscopically) or TACE or a combination of the above as defined by radiologic criteria (hepatoma protocol MRI or CT scan performed 4-6 weeks after the procedure).
* No more than two ablative procedures prior to enrollment
* Presence of portal hypertension, as defined by HVPG of \>5 mmHg
* EGD for variceal screening performed within 6 months of entry into the study unless the patient is already on a stable dose of a non selective beta-blocker (adjusted to obtain a heart rate of 55-60 bpm) or treated with variceal band ligation.
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
* Signed informed consent
20 Years
75 Years
ALL
No
Sponsors
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Onyx Therapeutics, Inc.
INDUSTRY
Yale University
OTHER
Responsible Party
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Principal Investigators
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Guadalupe Garcia-Tsao, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
VA Medical Center West Haven
West Haven, Connecticut, United States
Brigham & Womens
Boston, Massachusetts, United States
New York University Langone Medical Center
New York, New York, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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1002006266
Identifier Type: -
Identifier Source: org_study_id