Direct Acting Agents in Hepatitis C Patients

Completed

• Conditions: Hepatitis C Recurrent; Hepatitis C; Hepatitis C Relapse

• Registration Number: NCT03145844
• Lead Sponsor: Fehmi Tabak

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.

Study Timeline

• Study Start: 2017-04-09
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

• Patients who used direct acting agents for Hepatitis C

Exclusion Criteria

• Patients younger then 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Up to 48 weeks	Adverse event list according to CTCAE v.4.03

Trial Locations

Locations (1)

Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey