A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
Status: | Active, not recruiting |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 71 |
Updated: | 4/6/2017 |
Start Date: | December 2012 |
End Date: | May 2017 |
An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination With Peginterferon α-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in
combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who
did not respond to treatment in a previous AbbVie/Abbott combination study.
combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who
did not respond to treatment in a previous AbbVie/Abbott combination study.
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in
combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who
did not respond to treatment in a previous AbbVie/Abbott combination study. The study will
test the safety and effects of this alternative treatment for up to 48 weeks.
combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who
did not respond to treatment in a previous AbbVie/Abbott combination study. The study will
test the safety and effects of this alternative treatment for up to 48 weeks.
Inclusion Criteria:
Main Inclusion: To be enrolled in this protocol, subjects must meet all of the following
inclusion criteria:
- Subject must have experienced virologic failure as defined in a previous
AbbVie/Abbott direct acting anti-viral combination trial.
- Female subjects of childbearing potential must be willing to use two effective forms
of birth control (not including oral contraceptives or contraceptives containing
ethinyl estradiol) while receiving study drug and for 7 months (or per local
ribavirin label) after stopping study drug
- Males must be surgically sterile or have male partners only or agree to practice two
effective forms of birth control throughout the course of the study, starting with
Study Day 1 and for 7 months (or per local ribavirin label) after the last dose of
study drug, unless abstinent from sexual intercourse.
- Subject must be considered an appropriate candidate for peginterferon alpha-2a,
ribavirin, ABT-450/r and ABT-267 therapy in the opinion of the investigator.
- Subject is infected with HCV genotype 1 at screening.
Subjects diagnosed with cirrhosis must also meet the following criteria:
- Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening.
- Absence of hepatocellular carcinoma based on a negative ultrasound, computed
tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months
prior to Screening or during the Screening period.
Exclusion Criteria:
- In subjects with a prior null or partial response to pegIFN/RBV treatment at any time
prior to pre-screening for this study or any prior failure with pegIFN/RBV plus
telaprevir, the presence of variants relative to the appropriate prototypic reference
sequence (H77 for 1a or Con1 for 1b) at any of the following positions: NS3 155, 156,
or 168; or NS5A 28, 29, 30, 31, 32, 58, or 93.
- Females who are pregnant or plan to become pregnant, or breast-feeding, or males
whose partners are pregnant or planning to become pregnant within 7 months (or per
local RBV label) after their last dose of RBV.
- Use of known strong inducers (e.g., phenobarbital, rifampin, carbamazepine, St.
John's Wort) of CYP3A within 2 weeks prior to study drug administration.
- Use of any medications contraindicated for use with peginterferon alpha-2a, RBV or
ritonavir within 2 weeks prior to study drug administration. Prior to entering the
study, subjects must be able to safely discontinue the contraindicated medication or
switch to an acceptable alternative under supervision of the investigator.
- Discontinuation of antiviral therapy due to intolerance or a DAA- or RBV-associated
adverse event in a previous AbbVie/Abbott DAA combination study.
Subjects with compensated cirrhosis must also not meet the following criteria:
- 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.
- Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
- A screening ultrasound suspicious for hepatocellular carcinoma and confirmed with a
subsequent CT scan or MRI during the screening period.
We found this trial at
24
sites
13001 East 17th Place
Aurora, Colorado 80045
Aurora, Colorado 80045
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2015 Randolph Road
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
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410 West 10th Avenue
Columbus, Ohio 43210
Columbus, Ohio 43210
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3201 South 16th Street
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
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1 Columbia Street
Poughkeepsie, New York 12601
Poughkeepsie, New York 12601
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607 Camden Street
San Antonio, Texas 78215
San Antonio, Texas 78215
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