Last updated: July 28, 2021
Sponsor: AbbVie
Overall Status: Completed
Phase
3
Condition
Hepatitis C; Chronic
Hepatitis
Liver Disorders
Treatment
N/AClinical Study ID
NCT02247401
M14-250
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)
- Subjects must meet one of the following:
- Treatment-naive: Subject has never received antiviral treatment for HCV infectionOR
- Treatment Experienced (Prior null responders, Partial responders or Relapsers topegylated-interferon [pegIFN]/RBV);
- Females must be post-menopausal, of non-child bearing potential or practicing specificforms of birth control
- In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy orFibroscan
- In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscanwith Child-Pugh score less than or equal to 6 at Screening and confirmed absence ofhepatocellular carcinoma
Exclusion
Exclusion Criteria:
- Females who are pregnant or breastfeeding
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virusantibody
- HCV genotype performed during screening indicating unable to genotype or co-infectionwith any other HCV genotype
- abnormal laboratory tests
- self-reports current drinking more than 2 drinks per day
- current enrollment in another investigational study
- previous treatment with a direct acting antiviral agent (DAA) containing regimen
- In substudy 1, evidence of liver cirrhosis
- In substudy 2, evidence of current or past Child-Pugh B or C classification andconfirmed presence of hepatocellular carcinoma
Study Design
Total Participants: 160
Study Start date:
November 04, 2014
Estimated Completion Date:
August 01, 2016
Study Description
Connect with a study center
Site Reference ID/Investigator# 127895
Cairo, 11559
EgyptSite Not Available
Site Reference ID/Investigator# 127941
Dakahliah,
EgyptSite Not Available
Site Reference ID/Investigator# 127899
Menoufiya, 35111
EgyptSite Not Available
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