Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults … (NCT02247401) | Clinical Trial Compass
CompletedPhase 3
Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
160 participantsStarted 2014-11-04
Plain-language summary
This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
Who can participate
Age range18 Years – 99 Years
SexALL
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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 infection OR
* Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon \[pegIFN\]/RBV);
* Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
* In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
* In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma
Exclusion Criteria:
* Females who are pregnant or breastfeeding
* Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
* HCV genotype performed during screening indicating unable to genotype or co-infection with 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 and confirmed presence of hepatocellular carcinoma
What they're measuring
1
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
Timeframe: 12 weeks after last dose
2
Number of Participants With Adverse Events
Timeframe: Screening until 30 days after last dose