MAGELLAN-3
Brief summary
The purpose of this study is to evaluate the efficacy and safety of co-administration of an active drug/an active drug 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.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 12 Years to 99 Years.
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.
- 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.
