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
NCT ID: NCT02247401
Last Updated: 2021-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2014-11-04
2016-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent \[DAA\]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
2 DAA
ABT-450/r/ABT-267 tablets
RBV
Ribavirin tablets
Arm B
ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
2 DAA
ABT-450/r/ABT-267 tablets
RBV
Ribavirin tablets
Arm C
ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
2 DAA
ABT-450/r/ABT-267 tablets
RBV
Ribavirin tablets
Interventions
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2 DAA
ABT-450/r/ABT-267 tablets
RBV
Ribavirin tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Kopecky-Bromberg, PhD
Role: STUDY_DIRECTOR
AbbVie
References
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Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, Soliman R, Mohey MA, Allam N, Zayed N, Asselah T, Hall C, Redman R, Mobashery N, Doss W. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):36-44. doi: 10.1016/S2468-1253(16)30002-4. Epub 2016 Jun 16.
Other Identifiers
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M14-250
Identifier Type: -
Identifier Source: org_study_id
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