EUCTR2015-003370-33-ESActive, not recruitingPhase 1
An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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:
- •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.
Investigators
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