Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 10/14/2017 |
| Start Date: | October 2015 |
| End Date: | December 2016 |
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)
This study seeks to assess the safety and efficacy of treatment with
ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin in non-cirrhotic, genotype 1a
(GT1a) hepatitis C virus infected participants who are treatment-naïve or
treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without
Ribavirin (RBV).
ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin in non-cirrhotic, genotype 1a
(GT1a) hepatitis C virus infected participants who are treatment-naïve or
treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without
Ribavirin (RBV).
Inclusion Criteria:
- Chronic HCV infection
- Non-cirrhotic subjects
- Screening laboratory results showing HCV Genotype 1a infection
- HCV treatment-naïve or if treated previously, only with IFN or pegINF with or without
RBV
Exclusion Criteria:
- Pregnant or breastfeeding women
- Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus
antibody (HIV Ab)
- HCV genotype of any subtype other than 1a or unable to subtype
- Prior or current use of any investigational or commercially available anti-HCV agents
other than IFN, pegIFN or RBV. Subjects with previous participation in trials of
investigational direct-acting antiviral agents (DAAs) may be enrolled if they can
produce documentation that they received only placebo.
- Current enrollment in another interventional clinical study or receipt of any
investigational product within 6 weeks prior to study drug administration.
We found this trial at
10
sites
Binghamton, New York 13901
Principal Investigator: Site Reference ID/Investigator# 144655, MD
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Annapolis, Maryland 21401
Principal Investigator: Site Reference ID/Investigator# 144659, MD
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Catonsville, Maryland 21228
Principal Investigator: Site Reference ID/Investigator# 144665, MD
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Gainesville, Florida 32610
Principal Investigator: Site Reference ID/Investigator# 144661, MD
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La Jolla, California 92093
Principal Investigator: Site Reference ID/Investigator# 144662, MD
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Macon, Georgia 31217
Principal Investigator: Site Reference ID/Investigator# 144667, MD
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Madison, Wisconsin 53792
Principal Investigator: Site Reference ID/Investigator# 144660, MD
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Manhasset, New York 11031
Principal Investigator: Site Reference ID/Investigator# 144656, MD
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San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 144664, MD
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Statesville, North Carolina 28677
Principal Investigator: Site Reference ID/Investigator# 144666, MD
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