A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar
Effectiveness of Daclatasvir-Containing Regimens in Patients Treated in Real-Life Setting in Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE) and Qatar
1 other identifier
observational
182
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2017
CompletedFirst Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedOctober 11, 2017
October 1, 2017
1.2 years
June 29, 2017
October 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Distribution of SVR12 by Treatment Regimen
12 weeks after the last dose of study treatment
Distribution of SVR12 by Country
12 weeks after the last dose of study treatment
Distribution of SVR12 by Genotype
12 weeks after the last dose of study treatment
Distribution of SVR12 by HCV-Treatment Experience
12 weeks after the last dose of study treatment
Distribution of SVR12 by HIV co-infection
12 weeks after the last dose of study treatment
- +3 more secondary outcomes
Study Arms (1)
daclatasvir patients in KSA, UAE, and Qatar
patients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Use of a daclatasvir-containing regimen in a clinical trial setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Local Institution
Doha, Saudi Arabia
Local Institution
Jeddah, 23325, Saudi Arabia
Local Institution
Riyadh-11211, 11211, Saudi Arabia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 2, 2017
Study Start
April 26, 2016
Primary Completion
June 27, 2017
Study Completion
June 27, 2017
Last Updated
October 11, 2017
Record last verified: 2017-10