EUCTR2011-005762-38-HUActive, not recruitingNot Applicable
A Randomized, Open-Label Study to Evaluate theSafety and Efficacy of Coadministration of ABT-450with Ritonavir (ABT-450/r) and ABT-267 in Adultswith Chronic Hepatitis C Virus Infection (PEARL-I)
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 320
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 between the age of 18 and 70 years, inclusive, at time of enrollment.
- •2.Subjects must meet one of the following categories:
- •Treatment-naïve: Subject has never received antiviral treatment for hepatitis C infection (Subjects with HCV genotype 1b infection with or without cirrhosis or HCV genotype 4 infection; Groups 1, 2, 4, and 7); OR•Prior null responders: Subject has documentation that they previously received pegIFN/RBV for at least 10 weeks and failed to achieve a 2 log10 IU/mL HCV RNA decrease at Week 12 (Week 10 to Week 16) (Subjects with HCV genotype 1b infection with or without cirrhosis or HCV genotype 4 infection; Groups 3, 5, 6, and 8); OR•Partial responder: Received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved = 2 log10 reduction in HCV RNA at Week 12 (Weeks 10 – 16), but failed to achieve HCV RNA undetectable at the end of treatment (Subjects with HCV genotype 1b infection and compensated cirrhosis or HCV genotype 4 infection; Group 5, 6, and 8); OR•Relapser: Received at least 36 weeks of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 52 weeks of treatment follow-up (Subjects with HCV genotype 1b infection and compensated cirrhosis or HCV genotype 4 infection; Group 5, 6, and 8).
- •3.Body mass index (BMI) is = 18 to < 38 kg/m2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
- •4.Chronic HCV genotype 1b or 4-infection for at least 6 months prior to study screening.
- •5.Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
- •Main Inclusion for Substudy 1:
- •1. Per local standard practice, documented results of:
- •- Liver biopsy within 24 months prior to screening or during screening demonstrating the absence of cirrhosis.
- •- Only in the absence of a biopsy within the 24 months prior to screening or during screening:
- •- a screening FibroTest score of = 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) = 2; or
- •- a screening FibroScan® result of < 9.6 kPa. Subjects with a non qualifying FibroTest/APRI or FibroScan result may only be enrolled if they have a qualifying liver biopsy performed during screening.
- •Main Inclusion for Substudy 2:
- •1. Per local standard practice, documentation of cirrhosis by one of the following methods:
- •- Previous histologic diagnosis on liver biopsy, e.g., Metavir Score of > 3 (including 3/4 or 3 – 4), Ishak score of > 4 or,
- •- FibroScan score = 14.6 kPa within 6 months of Screening or during the Screening Period (FibroScan must be locally approved to qualify for entrance criteria). Subjects with a non-qualifying FibroScan result may only be enrolled if they have a qualifying liver biopsy performed during screening.
- •2. Compensated cirrhosis defined as Child-Pugh score of = 6 at Screening.
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
- •1.History of severe, life-threatening or other significant sensitivity to any drug.
- •2.Females who are pregnant or breastfeeding.
- •3.Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
- •4.Positive test result for hepatitis B surface antigen or anti-HIV antibodies.
- •5.Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis.
- •Main Exclusion for Substudy 1:
- •1. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis.
- •2. Absolute neutrophil count (ANC) < 1500 cells/µL (< 1200 cells/µL for subjects of black/African descent)
- •Main Exclusion for Substudy 2:
- •1. Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
Investigators
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