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NCT03145844 Clinical Trial

Direct Acting Agents in Hepatitis C Patients

Hepatitis C Clinical Trial

— HEPCTURKEY  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03145844
Other study ID # HEPCTURKEY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2017
Est. completion date December 31, 2018

Study information
Verified date September 2019
Source Viral Hepatitis Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 2700
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who used direct acting agents for Hepatitis C

Exclusion Criteria:

- Patients younger then 18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Cerrahpasa Medical Faculty Istanbul

Sponsors (2)
Lead Sponsor Collaborator
Fehmi Tabak Viral Hepatitis Society

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease management with direct acting agents 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) Beginning of treatment - 12 weeks after the treatment ended (36 weeks)
Secondary Incidence of Treatment-Emergent Adverse Events Adverse event list according to CTCAE v.4.03 Up to 48 weeks
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