Hepatitis CNCT03205618
A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar
An observational study of Hepatitis C, run by Bristol-Myers Squibb at 3 sites in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Non-Interventional
- How many people
- 182 participants
- Where
- 3 sitesSaudi Arabia
- Study dates
- 26 Apr 2016to 27 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Use of a daclatasvir-containing regimen in a clinical trial setting
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
3 sites in 1 country.
Saudi Arabia3 sites
Local Institution
Doha
Local Institution
Jeddah, 23325
Local Institution
Riyadh-11211, 11211
About this study
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
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.
- Conditions
- Hepatitis C
- Being tested
- Non-Interventional
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| daclatasvir patients in KSA, UAE, and Qatar | patients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after the last dose of study treatment
Secondary outcomes (8)
Distribution of SVR12 by Treatment Regimen
Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin.
Measured: 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.
Measured: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Genotype
Subgroups genotype 3 and genotype 4
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 weeks after the last dose of study treatment
Incidence of Serious Adverse Events (SAE)
Measured by number of patients reporting SAEs
Measured: Up to 12 months
Incidence of Adverse Events leading to discontinuation
Measured by number of patients reporting AEs that result in treatment discontinuation
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start26 Apr 2016
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205618
- Sponsor's protocol ID
- AI444-382
- Status last verified
- Oct 2017
- First submitted
- 29 Jun 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03205618
- Acronym / sponsor ID
- AI444-382
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| daclatasvir patients in KSA, UAE, and Qatar | – | Other: Non-Interventionalpatients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Use of a daclatasvir-containing regimen in a clinical trial setting
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | daclatasvir patients in KSA, UAE, and Qatar |
Primary outcome
Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
Time frame: 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.
8 secondary outcomes
Distribution of SVR12 by Treatment Regimen
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Country
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Genotype
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by HCV-Treatment Experience
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by HIV co-infection
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by previous liver transplantation
Time frame: 12 weeks after the last dose of study treatment
Incidence of Serious Adverse Events (SAE)
Time frame: Up to 12 months
Incidence of Adverse Events leading to discontinuation
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Bristol-Myers Squibb at 3 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12) (time frame: 12 weeks after the last dose of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.