Hepatitis CNCT03181074
Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
An observational study of Hepatitis C, run by Bristol-Myers Squibb at 2 sites in Mexico.
Trial summary
This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico. 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
- 10 participants
- Where
- 2 sitesMexico
- Study dates
- 21 Oct 2015to 19 Aug 2019
- 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: Patients with chronic Hepatitis C who are being given daclatasvir for the treatment and cure of chronic Hepatitis C at the sentinel sites for the CNFV in Mexico. Patients will be treated according to the clinical judgment of the treating physician.
Who may be able to join
- 1. This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period.
Who cannot join
- Subjects who received daclatasvir as part of a clinical trial.
- Subjects who received daclatasvir for any indication other than local approved.
- Contraindications included in the approved Mexican prescribing information.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Local Institution
Benito Juárez, Mexico City, 03900
Local Institution
Mexico City, Mexico City, 14050
About this study
This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.
- 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 |
|---|---|---|
| CHC patients in Mexico | patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
adverse events (AEs) on treatment with DCV in patients with chronic hepatitis C treated by doctors at participating sentinel sites for the CNFV in Mexico
Measured: Approximately 24 months
Secondary outcomes (5)
Distribution of Adverse Events by Age
Measured: Approximately 24 months
Distribution of Adverse Events by Gender
Measured: Approximately 24 months
Distribution of Adverse Events by Interruption or Switch of Medication
Measured: Approximately 24 months
Distribution of Adverse Events by Concomitant Medication
Measured: Approximately 24 months
Distribution of Adverse Events by Race
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start21 Oct 2015
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
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
- Prospective
- Enrolment
- 10 participants (estimated)
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
- NCT03181074
- Sponsor's protocol ID
- AI444-330
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
- ClinicalTrials.gov ID
- NCT03181074
- Acronym / sponsor ID
- AI444-330
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2015 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 8 Jun 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.
This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHC patients in Mexico | – | Other: Non-Interventionalpatients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic Hepatitis C who are being given daclatasvir for the treatment and cure of chronic Hepatitis C at the sentinel sites for the CNFV in Mexico. Patients will be treated according to the clinical judgment of the treating physician.
Key inclusion criteria (1 listed)
- 1. This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period.
Key exclusion criteria (3 listed)
- Subjects who received daclatasvir as part of a clinical trial.
- Subjects who received daclatasvir for any indication other than local approved.
- Contraindications included in the approved Mexican prescribing information.
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 | CHC patients in Mexico |
Primary outcome
Number of Adverse Events
Time frame: Approximately 24 months
adverse events (AEs) on treatment with DCV in patients with chronic hepatitis C treated by doctors at participating sentinel sites for the CNFV in Mexico
5 secondary outcomes
Distribution of Adverse Events by Age
Time frame: Approximately 24 months
Distribution of Adverse Events by Gender
Time frame: Approximately 24 months
Distribution of Adverse Events by Interruption or Switch of Medication
Time frame: Approximately 24 months
Distribution of Adverse Events by Concomitant Medication
Time frame: Approximately 24 months
Distribution of Adverse Events by Race
Time frame: Approximately 24 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 18 Mar 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
2 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 2 sites in Mexico.
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 1 inclusion and 3 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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 Adverse Events (time frame: Approximately 24 months). 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 18 Mar 2020.