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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 August 2021 |
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Main ID: |
NCT02247401 |
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Date of registration:
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19/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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An Open-Label Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt |
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Date of first enrolment:
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November 4, 2014 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02247401 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Sarah Kopecky-Bromberg, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Genotype 4
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HCV
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Hepatitis C Infection
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Intervention(s)
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Drug: RBV
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Drug: 2 DAA
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Primary Outcome(s)
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Number of Participants With Adverse Events
[Time Frame: Screening until 30 days after last dose]
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
[Time Frame: 12 weeks after last dose]
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Secondary Outcome(s)
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Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm
[Time Frame: Up to 12 weeks after first dose]
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Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm
[Time Frame: Up to 12 or 24 weeks after first dose]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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