A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study



Status:Enrolling by invitation
Conditions:Infectious Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 99
Updated:12/6/2018
Start Date:November 21, 2016
End Date:March 24, 2023

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An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)

The purpose of this study is to evaluate the efficacy and safety of co-administration of
ABT-493/ABT-530 plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV)
genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic
participants) who have experienced virologic failure in an AbbVie parent clinical study.


Inclusion Criteria:

- Male or female subjects must be adults (18 years of age or older) or adolescents (12
to less than 18 years of age weighing at least 35 kg).

- Subject must have experienced virologic failure during or after treatment with
ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic
failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or
ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at
AbbVie's discretion. Treatment in the parent study must have been completed or
discontinued at least 1 month prior to the Screening Visit.

- Subjects must be able to understand and adhere to the study visit schedule and all
other protocol requirements.

- Cirrhotic Subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at
Screening and no current or past evidence of Child-Pugh B or C Classification or no
clinical history of liver decompensation, including ascites noted on physical exam,
hepatic encephalopathy or esophageal variceal bleeding.

- Cirrhotic Subjects must have absence of hepatocellular carcinoma (HCC) as indicated by
a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance
imaging (MRI) within 3 months prior to Screening or a negative US at Screening.

Exclusion Criteria:

- History of severe, life-threatening or other clinically significant sensitivity to any
study drug or drug component.

- Female subject who is pregnant, breastfeeding or is considering becoming pregnant
during the study or for 4 months after the last dose of study drug, or as directed per
the local RBV label, whichever is more restrictive.

- Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse that could preclude adherence to the protocol in the opinion of the
investigator, and failure in an AbbVie HCV parent study due to non-virologic reasons.

- Positive test result at Screening for hepatitis B surface antigen (HBsAg).

- Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.

- Discontinuation from the AbbVie HCV parent study for reasons other than virologic
failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse
event).

- Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV
parent study.
We found this trial at
9
sites
1324 Wolf Park Drive
Germantown, Tennessee 38138
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Buffalo, New York 14203
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Detroit, Michigan 48202
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Dothan, AL
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Herston,
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5901 West Olympic Boulevard
Los Angeles, California 90036
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Los Angeles, CA
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San Antonio, TX
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Statesville, North Carolina 28677
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Statesville, NC
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