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

Use our guide to learn which trials are right for you!

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.

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.

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
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
13001 East 17th Place
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1160 Huffman Road
Birmingham, Alabama 35215
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
2035 Paraguay
Buenos Aires, C1121
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
2015 Randolph Road
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
410 West 10th Avenue
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
480 Honeysuckle Road
Dothan, Alabama 36305
?
mi
from
Dothan, AL
Click here to add this to my saved trials
356 East Midway Road
Fort Pierce, Florida 34982
?
mi
from
Fort Pierce, FL
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1421 North State Street
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
Click here to add this to my saved trials
425 Volker Boulevard
Kansas City, Missouri 64131
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Medford, Oregon 97504
?
mi
from
Medford, OR
Click here to add this to my saved trials
3201 South 16th Street
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
427 Broadway
Monticello, New York 12701
?
mi
from
Monticello, NY
Click here to add this to my saved trials
5450 South Green Street
Murray, Utah 84123
?
mi
from
Murray, UT
Click here to add this to my saved trials
1064 Goodlette-Frank Road
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
1 Columbia Street
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
607 Camden Street
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
6367 Alvarado Court
San Diego, California 92120
?
mi
from
San Diego, CA
Click here to add this to my saved trials
8008 Frost Street
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials