An observational study in Hepatitis C, sponsored by Bristol-Myers Squibb. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Bristol-Myers Squibb · Observational
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 1,941 is above the median of 245 across 574 observational studies indexed under Hepatitis C.
Browse Hepatitis C studies →Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.
Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Primary Care Clinic
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Exclusion Criteria:
Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities
Time frame: 6 months to 5 years
Incidence proportion of AEs leading to discontinuation of study therapy
Time frame: 6 months to 5 years
Incidence rate of AEs leading to discontinuation of study therapy
Time frame: 6 months to 5 years
Timing of laboratory abnormalities by toxicity grade
Time frame: 6 months to 5 years
Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected
Time frame: 4 Weeks to 24 Weeks
The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)
Time frame: 24 Weeks to 36 Weeks
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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