NCT03145844

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

May 3, 2017

Last Update Submit

September 30, 2019

Conditions

Hepatitis CHepatitis C RelapseHepatitis C Recurrent

Keywords

DAAHepatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Up to 48 weeks

Study Arms (1)

Direct Acting Agents

No Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients who used direct acting agents for Hepatitis C

You may not qualify if:

  • Patients younger then 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Dirican E, Bal T, Onlen Y, Sarigul F, User U, Sari ND, Kurtaran B, Senates E, Gunduz A, Zerdali E, Karsen H, Batirel A, Karaali R, Guner HR, Yamazhan T, Kose S, Erben N, Ince NK, Koksal I, Oztoprak N, Yoruk G, Komur S, Kaya SY, Bozkurt I, Gunal O, Yildiz IE, Inan D, Barut S, Namiduru M, Tosun S, Turker K, Sener A, Hizel K, Baykam N, Duygu F, Bodur H, Can G, Gul HC, Tartar AS, Celebi G, Sunnetcioglu M, Karabay O, Kumbasar Karaosmanoglu H, Sirmatel F, Tabak OF. Assisting the Diagnosis of Cirrhosis in Chronic Hepatitis C Patients Based on Machine Learning Algorithms: A Novel Non-Invasive Approach. J Clin Lab Anal. 2025 Jun;39(12):e70054. doi: 10.1002/jcla.70054. Epub 2025 May 19.

    PMID: 40384539DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Study Officials

  • Fehmi Tabak, Prof

    Viral Hepatitis Society

    PRINCIPAL INVESTIGATOR

  • Tansu Yamazhan, Prof

    Viral Hepatitis Society

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Fehmi Tabak

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 9, 2017

Study Start

April 9, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

TU(1)