An observational study in Hepatitis C, sponsored by Bristol-Myers Squibb. Completed at 3 sites in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by Bristol-Myers Squibb · Observational
The study will provide safety and efficacy information among patients receiving daclatasvir. It will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in KSA, UAE, and Qatar.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 182 is below the median of 244 across 567 observational studies indexed under Hepatitis C.
Browse Hepatitis C studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study will enroll all patients initiating a new daclatasvir-containing HCV treatment, regardless of treatment history and previous treatment response from availability of the drug on country markets up to 01-Oct-2015.
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
patients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar
Other: Non-Interventional
Non-Interventional
Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
Patients will be considered to have achieved SVR12 if they have a documented undetectable viral load on or after Week 12 following the end of treatment.
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Treatment Regimen
Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin.
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Country
Defined as the country where treatment with a daclatasvir containing regimen was initiated. Subgroups include Saudi Arabia, UAE, and Qatar.
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Genotype
Subgroups genotype 3 and genotype 4
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by HCV-Treatment Experience
Subgroups include patients in which prior treatment with IFN and RBV has failed; prior treatment with IFN, RBV and telaprevir or boceprevir has failed; previous treatment with IFN, RBV and simeprevir has failed; previous treatment with sofosbuvir and RBV has failed.
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by HIV co-infection
Subgroup defined as HIV diagnosis prior to the initiation of daclatasvir containing regimen.
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by previous liver transplantation
Subgroup defined by patients undergoing a liver transplant for any cause prior to the initiation of a daclatasvir containing regimen
Time frame: 12 weeks after the last dose of study treatment
Incidence of Serious Adverse Events (SAE)
Measured by number of patients reporting SAEs
Time frame: Up to 12 months
Incidence of Adverse Events leading to discontinuation
Measured by number of patients reporting AEs that result in treatment discontinuation
Time frame: Up to 12 months
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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