Direct Acting Agents in Hepatitis C Patients

Evaluation of Efficacy and Safety of Direct Acting Agents in Hepatitis C Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03145844

Acronym

HEPCTURKEY

Enrollment

2700

Registered

2017-05-09

Start date

2017-04-09

Completion date

2018-12-31

Last updated

2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Hepatitis C Recurrent, Hepatitis C Relapse

Keywords

DAA, Hepatitis

Brief summary

This study is a retrospective study conducted at 36 sites. Planned target patient number is 1000.

Detailed description

Approximately 36 centers will be included in Turkey. Centers will be selected from clinics of infection and clinical microbiology. The inclusion of 1000 patients was targeted. All data will be retrospectively collected from the medical records of the patients. Patient visit is not necessary.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who used direct acting agents for Hepatitis C

Exclusion criteria

* Patients younger then 18 years

Design outcomes

Primary

Measure	Time frame	Description
Disease management with direct acting agents	Beginning of treatment - 12 weeks after the treatment ended (36 weeks)	To assess disease management of chronic hepatitis C patients using direct acting agents (DAA) at national level, especially change in HCVRNA levels 12 weeks after the 24 weeks treatment (SVR12)

Secondary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events	Up to 48 weeks	Adverse event list according to CTCAE v.4.03

Countries

Turkey (Türkiye)

Outcome results