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

Hepatitis C Clinical Trial

Official title:

Effectiveness of Daclatasvir-Containing Regimens in Patients Treated in Real-Life Setting in Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE) and Qatar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205618
• Other study ID #: AI444-382
• Status: Completed
• Phase: N/A
• First received: June 29, 2017
• Last updated: October 10, 2017
• Start date: April 26, 2016
• Est. completion date: June 27, 2017

Study information

• Verified date: October 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

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

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
Saudi Arabia	Local Institution	Doha
Saudi Arabia	Local Institution	Jeddah
Saudi Arabia	Local Institution	Riyadh-11211

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks after the last dose of study treatment
Secondary	Distribution of SVR12 by Treatment Regimen	Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin.	12 weeks after the last dose of study treatment
Secondary	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.	12 weeks after the last dose of study treatment
Secondary	Distribution of SVR12 by Genotype	Subgroups genotype 3 and genotype 4	12 weeks after the last dose of study treatment
Secondary	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.	12 weeks after the last dose of study treatment
Secondary	Distribution of SVR12 by HIV co-infection	Subgroup defined as HIV diagnosis prior to the initiation of daclatasvir containing regimen.	12 weeks after the last dose of study treatment
Secondary	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	12 weeks after the last dose of study treatment
Secondary	Incidence of Serious Adverse Events (SAE)	Measured by number of patients reporting SAEs	Up to 12 months
Secondary	Incidence of Adverse Events leading to discontinuation	Measured by number of patients reporting AEs that result in treatment discontinuation	Up to 12 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form