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
This trial has been completed.
|Condition||chronic hepatitis c infection|
|Treatments||ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin|
|Start date||July 2015|
|End date||December 2016|
|Trial size||3 participants|
|Trial identifier||NCT02504099, 2015-001049-10, M14-726|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Gainesville, FL||Site Reference ID/Investigator# 137887||completed|
|Chicago, IL||Site Reference ID/Investigator# 138486||completed|
|Minneapolis, MN||University of Minnesota / Masonic Cancer Center||withdrawn|
|New York, NY||Columbia University / Herbert Irving Cancer Center||no longer recruiting|
|Philadelphia, PA||Site Reference ID/Investigator# 137888||completed|
|Houston, TX||Site Reference ID/Investigator# 137891||completed|
|Murray, UT||Site Reference ID/Investigator# 137883||completed|
|Seattle, WA||Site Reference ID/Investigator# 137892||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
time frame: 12 weeks after the last dose of study drug
Percentage of Participants With Virologic Failure During Treatment
time frame: Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12, 16, 20 and 24.
Percentage of Participants With Virologic Relapse After Treatment
time frame: Between End of Treatment (Week 12 or Week 24) and Post-Treatment (up to Week 12 Post-Treatment)
The percentage of participants with long term clinical outcomes from treatment through 24 weeks of follow-up.
time frame: End of Treatment and Post Treatment Weeks 4, 12, 24.
The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.
time frame: Baseline, Treatment period weeks 2, 4, 8, 12, 16, 20 and 24 and Post Treatment Period Weeks 4, 12, 24.
Male or female participants from 18 years up to 120 years old.
- Male or female, at least 18 years of age at time of screening.
- Chronic HCV infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection.
- 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)
- 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
- Documented complete response to HCC treatment.
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
- 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.
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- Patients regardless of eligibility to liver transplant, who have a comorbid disease that might preclude completion of study follow-up.
- 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.
|Official title||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)|
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