An observational study in Chronic Hepatitis C Virus, sponsored by AbbVie. Completed at 170 sites in Japan. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-06-12.
Sponsored by AbbVie · Observational
The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in Japan.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 449 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with Chronic hepatitis C virus (HCV) genotype 2
Exclusion Criteria:
Participants with confirmed chronic HCV genotype 2, receiving paritaprevir/ritonavir/ombitasvir and ribavirin according to standard of care and in line with the current local label
Percentage of Participants with Sustained Virologic Response (SVR12)
Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.
Time frame: 12 weeks after last dose of study drug.
Percentage of Participants with Virologic Failure During Treatment (breakthrough)
HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment.
Time frame: Up to 12 Weeks
Percentage of Participants with Virologic Failure After Treatment (relapse)
Undetectable viremia (HCV RNA less than LLOQ) at the end of the 16 weeks treatment but subsequent viremia (HCV RNA greater than or equal to LLOQ) during the follow-up period of 24 weeks after treatment.
Time frame: Post-treatment 24 weeks
Percentage of Participants with Sustained Virologic Response (SVR24)
HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.
Time frame: 24 weeks after the last dose of study drug
Showing the first 100 of 170 sites.
Plan to share: Undecided
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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