A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar

Completed

• Conditions: Hepatitis C
• Interventions: Other: Non-Interventional

• Registration Number: NCT03205618
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-26
• Primary Completion: 2017-06-27
• Study Completion: 2017-06-27
• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Adult patients greater than or equal to 18 years of age
• Diagnosed with chronic hepatitis C
• Ended treatment with daclatasvir-containing regimen no later than 01-Oct-2015

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Exclusion Criteria

• Use of a daclatasvir-containing regimen in a clinical trial setting

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
daclatasvir patients in KSA, UAE, and Qatar	Non-Interventional	patients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar

Primary Outcome Measures

Name	Time	Method
Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)	12 weeks after the last dose of study treatment	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAE)	Up to 12 months	Measured by number of patients reporting SAEs
Incidence of Adverse Events leading to discontinuation	Up to 12 months	Measured by number of patients reporting AEs that result in treatment discontinuation
Distribution of SVR12 by previous liver transplantation	12 weeks after the last dose of study treatment	Subgroup defined by patients undergoing a liver transplant for any cause prior to the initiation of a daclatasvir containing regimen
Distribution of SVR12 by Treatment Regimen	12 weeks after the last dose of study treatment	Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin.
Distribution of SVR12 by HIV co-infection	12 weeks after the last dose of study treatment	Subgroup defined as HIV diagnosis prior to the initiation of daclatasvir containing regimen.
Distribution of SVR12 by Genotype	12 weeks after the last dose of study treatment	Subgroups genotype 3 and genotype 4
Distribution of SVR12 by HCV-Treatment Experience	12 weeks after the last dose of study treatment	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.
Distribution of SVR12 by Country	12 weeks after the last dose of study treatment	Defined as the country where treatment with a daclatasvir containing regimen was initiated. Subgroups include Saudi Arabia, UAE, and Qatar.

Trial Locations

Locations (1)

Local Institution; 🇸🇦 Riyadh-11211, Saudi Arabia