Direct Acting Agents in Hepatitis C Patients (HEPCTURKEY)

September 30, 2019 updated by: Fehmi Tabak

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Cerrahpasa Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed as Hepatitis C and used direct acting agents.

Description

Inclusion Criteria:

  • Patients who used direct acting agents for Hepatitis C

Exclusion Criteria:

  • Patients younger then 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Direct Acting Agents
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease management with direct acting agents
Time Frame: 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)
Beginning of treatment - 12 weeks after the treatment ended (36 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fehmi Tabak

Collaborators

Viral Hepatitis Society

Investigators

  • Principal Investigator: Fehmi Tabak, Prof, Viral Hepatitis Society
  • Study Director: Tansu Yamazhan, Prof, Viral Hepatitis Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 9, 2017

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (ACTUAL)

May 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPCTURKEY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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