Hepatitis CHEPCTURKEYNCT03145844
Direct Acting Agents in Hepatitis C Patients
An observational study of Hepatitis C and Hepatitis C Relapse, run by Fehmi Tabak at 1 site in Turkey (Türkiye).
Trial summary
This study is a retrospective study conducted at 36 sites. Planned target patient number is 1000. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hepatitis C Relapse, Hepatitis C Recurrent
- How many people
- 2,700 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed as Hepatitis C and used direct acting agents.
Who may be able to join
- Patients who used direct acting agents for Hepatitis C
Who cannot join
- Patients younger then 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis C, Hepatitis C Relapse, Hepatitis C Recurrent
- Keywords
- DAA, Hepatitis
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Direct Acting Agents | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Beginning of treatment - 12 weeks after the treatment ended (36 weeks)
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Adverse event list according to CTCAE v.4.03
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start9 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fehmi Tabak
- Sponsor type
- University, hospital or other
- Collaborators
- Viral Hepatitis Society
- Responsible party
- Sponsor-investigator, Fehmi Tabak, Viral Hepatitis Society
- Investigators
- Fehmi Tabak, Prof, Principal investigator, Viral Hepatitis SocietyTansu Yamazhan, Prof, Study director, Viral Hepatitis Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145844
- Sponsor's protocol ID
- HEPCTURKEY
- Acronym
- HEPCTURKEY
- Status last verified
- Sep 2019
- First submitted
- 3 May 2017
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40384539
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Direct Acting Agents in Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT03145844
- Acronym / sponsor ID
- HEPCTURKEY / HEPCTURKEY
- Conditions
- Hepatitis C, Hepatitis C Relapse, Hepatitis C Recurrent
- Keywords
- DAA, Hepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- Fehmi TabakUniversity, hospital or other
- Collaborators
- Viral Hepatitis Society
- Study start
- 9 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct Acting Agents | – | –No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed as Hepatitis C and used direct acting agents.
Key inclusion criteria (1 listed)
- Patients who used direct acting agents for Hepatitis C
Key exclusion criteria (1 listed)
- Patients younger then 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Derived from this study: PubMed 40384539Dirican 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fehmi Tabak, Prof principal investigator
Viral Hepatitis Society
Tansu Yamazhan, Prof study director
Viral Hepatitis Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hepatitis C Relapse, run by Fehmi Tabak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease management with direct acting agents (time frame: Beginning of treatment - 12 weeks after the treatment ended (36 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03145844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.