A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma



Status:Completed
Conditions:Liver Cancer, Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - 120
Updated:11/16/2017
Start Date:July 2015
End Date:December 2016

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Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)

The purpose of this study is to evaluate the safety and efficacy of
ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered
with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or
genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with
compensated cirrhosis.


Inclusion Criteria:

1. Male or female, at least 18 years of age at time of screening.

2. Chronic HCV infection prior to study enrollment with screening laboratory results
indicating HCV genotype 1 or 4 infection.

3. Early stage HCC diagnosed based on the typical hallmark of HCC (hypervascular in the
arterial phase with washout in the portal venous or delayed phases)

4. Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening.

• A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that
requires the need to apply diuretic treatment to control ascites

5. Documented complete response to HCC treatment.

6. Females must be post-menopausal for more than 2 years or surgically sterile or
practicing acceptable forms of birth control

Exclusion Criteria:

1. Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in subjects
receiving OBV/PTV/r with and without DSV, strong inducers and inhibitors (e.g.,
gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in subjects receiving OBV/PTV/r with DSV,
medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2
weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For
medications contraindicated with AbbVie's 2-DAA and 3-DAA regimen, refer to the
recommended prescribing information section of the approved local product labels.

2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human
immunodeficiency virus antibody (HIV Ab).

3. Patients regardless of eligibility to liver transplant, who have a comorbid disease
that might preclude completion of study follow-up.

4. Clinically significant abnormalities, other than HCV infection, in a subject with HCC
based upon the medical history, physical examination, vital signs, laboratory profile
and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate
for this study in the opinion of the investigator.
We found this trial at
7
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