A Study to Evaluate Ombitasvir/ Paritaprevir / Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 166

Inclusion Criteria

1. Male or female at least 18 years of age at time of Screening.
2. HCV infection at Screening defined as: Positive for anti-HCV antibody (Ab) at Screening and HCV RNA > 1,000 IU/mL at Screening.
3. Screening laboratory result indicating HCV genotype 1b infection only.
4. Subject has never received commercial or investigational anti-HCV agents for hepatitis C infection (treatment-naïve subject).
5. Absence of cirrhosis, as documented by meeting one of the following criteria (per local standard practice):
• A liver biopsy within 12 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a METAVIR Score of 3 or less, Ishak score of 4 or less;
• A FibroScan performed within 3 months prior to or during screening with a score of < 12.5 kPa; or
• A screening FibroTest score of = 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) = 2 (Subjects with a screening FibroTest
result that is = 0.72 and an APRI > 2, or a FibroTest result that is > 0.72 and an APRI = 2 must have a FibroScan or liver biopsy performed during screening to document absence of cirrhosis. These subjects will be allowed to enroll only with approval of the AbbVie Scientific Director).
If more than one method is used to determine the presence or absence of cirrhosis, the results of a liver biopsy will take precedence over FibroScan and FibroTest and the results of FibroScan will take
precedence over FibroTest.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Evidence of HCV genotype or subtype other than GT1b during screening, including the presence of GT1b with another genotype or GT1
subtype.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) (test).
3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices or prior biopsy showing cirrhosis.
4. Screening laboratory analyses showing any of the following abnormal laboratory results:
• Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
• Albumin < 3.5 g/dL
• Hemoglobin < 10 g/dL
• Platelets < 120,000 cells per mm3
• Total bilirubin = 3.0 mg/dL
• International normalized ratio (INR) > 1.5. Subjects with a known
inherited blood disorder and INR > 1.5 may be enrolled with permission
of the AbbVie Scientific Director.
5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the subject an unsuitable candidate for this study or to receive ombitasvir/paritaprevir/ritonavir or dasabuvir in the opinion of the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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