CClinicalTrials.gg
CompletedNCT03181074Updated Mar 18, 2020

Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults

An observational study in Hepatitis C, sponsored by Bristol-Myers Squibb. Completed at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 10 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  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.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who received daclatasvir as part of a clinical trial.
  2. Subjects who received daclatasvir for any indication other than local approved.
  3. Contraindications included in the approved Mexican prescribing information.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • CHC patients in Mexico

    patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico

    Other: Non-Interventional

Interventions

  • OtherNon-Interventional

    Non-Interventional

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Approximately 24 months

Secondary outcomes

  1. Distribution of Adverse Events by Age

    Time frame: Approximately 24 months

  2. Distribution of Adverse Events by Gender

    Time frame: Approximately 24 months

  3. Distribution of Adverse Events by Interruption or Switch of Medication

    Time frame: Approximately 24 months

  4. Distribution of Adverse Events by Concomitant Medication

    Time frame: Approximately 24 months

  5. Distribution of Adverse Events by Race

    Time frame: Approximately 24 months

07

Study locations

2 sites
  • Local Institution
    Benito Juarez, Distrito Federal 03900, Mexico
  • Local Institution
    Mexico, D.f., Distrito Federal 14050, Mexico
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03181074
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 8, 2017
Start date
Oct 21, 2015
Primary completion
Aug 19, 2019
Completion
Aug 19, 2019
Last update
Mar 18, 2020

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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