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
Status: | Completed |
---|---|
Conditions: | Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 100 |
Updated: | 12/9/2016 |
Start Date: | June 2015 |
End Date: | December 2016 |
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
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).
full dose RBV or RBV add on in treatment naive subjects with chronic Hepatitis C Virus
(HCV).
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.
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.
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.
We found this trial at
2
sites
Creteil, 94010
Principal Investigator: Site Reference ID/Investigator# 132539, MD
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Buffalo, New York
Principal Investigator: Site Reference ID/Investigator# 131934, MD
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