NCT06010524

Brief Summary

This is a retrospective, non-interventional study. Investigators from infectious diseases and gastroenterology departments will participate this study. Patients data will be collected from hospital medical records.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 20, 2023

Last Update Submit

August 26, 2023

Conditions

Hepatitis C

Keywords

Hepatitis CVOSEVI

Outcome Measures

Primary Outcomes (1)

  • Sustained Virology Response 12

    Rate of the patients with undetectabled HCVRNA after 12 weeks of the completion of SOF/VEL/VOX treatment

    From start date of treatment to 12 weeks after the completion of treatment

Eligibility Criteria

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

All CHC patients who received Soforbuvir/Velpatasvir/Voxilaprevir combination therapy will be included in this study. The information of these patients will be recorded retrospectively from the Hospital registry system.

You may qualify if:

  • Patients diagnosed as chronic hepatitis C and aged 18 and older
  • Patients received SOF/VEL/VOX treatment

You may not qualify if:

  • Decompensated cirrhotic HCV patients
  • Having HCC
  • eGFR\<30 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fehmi Tabak, Prof

    Cerrahpasa Medical Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fehmi Tabak, Prof

CONTACT

+905322763788fehmitabak@yahoo.com

Ilker Kurkcu

CONTACT

+905326354515ilker.kurkcu@sentez-cro.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2023

First Posted

August 24, 2023

Study Start

February 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)