Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
This trial has been completed.
|Conditions||chronic hepatitis c, hepatitis c (hcv), hepatitis c genotype 1a|
|Treatments||ombitasvir/abt-450/ritonavir, dasabuvir, ribavirin|
|Start date||June 2015|
|End date||April 2016|
|Trial size||46 participants|
|Trial identifier||NCT02493855, 2014-001478-32, M14-242|
This is a study of ombitasvir/ABT-450/ritonavir and dasabuvir with low dose ribavirin (RBV), full dose RBV or RBV add on in treatment naive subjects with chronic Hepatitis C Virus (HCV).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Slope of the second phase decline in plasma HCV RNA levels during treatment
time frame: From Week 0 to Week 2
Male or female participants from 18 years up to 100 years old.
Inclusion Criteria: 1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection. 2. Chronic HCV infection. 3. Subjects must be non-cirrhotic. 4. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay. 3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment. 4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or NS5A inhibitors. 5. History or solid organ transplant. 6. Screening laboratory analysis that shows abnormal results.
|Official title||An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection|
|Description||A study to evaluate the effect of RBV on second phase plasma HCV ribonucleic acid (RNA) decline in subjects who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose RBV compared to ombitasvir/ABT-450/ritonavir with low dose RBV or without RBV in treatment-naive HCV genotype (GT) 1a-infected adult subjects.|
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