Hepatitis C Virus InfectionHCV-aMAPNCT07687758
Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced Chronic Liver Disease Following Sustained Virological Response: Validation of the aMAP Score
An observational study of Hepatitis C Virus Infection and Compensated Advanced Chronic Liver Disease, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection, Compensated Advanced Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
- What is being tested?
- Non-invasive Risk Score Assessment
- How many people
- 571 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2013to 31 Jul 2023
- 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: Adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated sofosbuvir-based direct-acting antiviral therapy at Siriraj Hospital between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion.
Who may be able to join
- Age 18 years or older
- Chronic hepatitis C virus infection treated with direct-acting antiviral therapy
- Documented sustained virological response at 12 weeks after treatment completion
- Evidence of compensated advanced chronic liver disease before direct-acting antiviral therapy, defined by at least one of the following: histologic F3 or F4 fibrosis, vibration-controlled transient elastography >10 kPa, radiologic features compatible with advanced fibrosis or cirrhosis, or clinical or endoscopic evidence of portal hypertension
- Minimum follow-up of 12 months after sustained virological response
Who cannot join
- Incomplete or missing medical records precluding outcome assessment
- Known or suspected hepatocellular carcinoma before initiating direct-acting antiviral therapy
- Failure to achieve sustained virological response at 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Risk of Hepatic Decompensation and Hepatocellular Carcinoma in Advanced Fibrotic or Cirrhotic Patients With Chronic Hepatitis C After Sustained Virologic Response
This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Patients treated at Siriraj Hospital between 2013 and 2023 were included if they had compensated advanced chronic liver disease and documented SVR12. The study compared FIB-4, APRI, ALBI, and aMAP scores calculated at SVR12 for prediction of hepatocellular carcinoma during long-term follow-up. The primary aim was to identify a very-low-risk subgroup in whom hepatocellular carcinoma surveillance might potentially be de-escalated.
Read the detailed description
This was a single-center retrospective cohort study conducted at Siriraj Hospital, Thailand. Consecutive adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated interferon-free sofosbuvir-based direct-acting antiviral therapy between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion were included. Compensated advanced chronic liver disease was defined according to Baveno VII criteria, including histologic F3/F4 fibrosis, vibration-controlled transient elastography greater than 10 kPa, or clinical evidence of portal hypertension.
Baseline demographic, clinical, laboratory, and transient elastography data were collected from electronic medical records. The FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12. Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy, failure to achieve SVR12, or incomplete medical records precluding outcome assessment were excluded.
The primary outcome was de novo hepatocellular carcinoma during follow-up. Predictive performance of the non-invasive scores was assessed using time-to-event analysis, Kaplan-Meier methods, Cox proportional hazards regression, and time-dependent receiver operating characteristic curves at 1, 3, 5, and 8 years.
- Conditions
- Hepatitis C Virus Infection, Compensated Advanced Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
- Being tested
- Non-invasive Risk Score Assessment
- Keywords
- Sustained Virological Response, Direct-acting Antiviral Therapy, aMAP Score, FIB-4, APRI, ALBI Score, HCC Surveillance, Risk Stratification
- Medical subject headings
- Hepatitis C, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Risk Score AssessmentOther
FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12 to evaluate their performance for predicting de novo hepatocellular carcinoma during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| HCV-related cACLD After SVR | Adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response at 12 weeks after sofosbuvir-based direct-acting antiviral therapy and were followed for de novo hepatocellular carcinoma. Receives: Other: Non-invasive Risk Score Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of de novo hepatocellular carcinoma
Occurrence of newly diagnosed hepatocellular carcinoma after achievement of sustained virological response (SVR12). Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy were excluded.
Measured: From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.
Secondary outcomes (4)
Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma
Time-dependent area under the receiver operating characteristic curve (AUC) of the FIB-4 score for predicting de novo hepatocellular carcinoma.
Measured: At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the APRI score for de novo hepatocellular carcinoma
Time-dependent area under the receiver operating characteristic curve (AUC) of the APRI score for predicting de novo hepatocellular carcinoma.
Measured: At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma
Time-dependent area under the receiver operating characteristic curve (AUC) of the ALBI score for predicting de novo hepatocellular carcinoma.
Measured: At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma
Time-dependent area under the receiver operating characteristic curve (AUC) of the aMAP score for predicting de novo hepatocellular carcinoma.
Measured: At 1, 3, 5, and 8 years after SVR12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jan 2013
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus InfectionStudies 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
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tawesak Tanwandee, Mahidol University
- Investigators
- Tawesak Tanwandee, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687758
- Sponsor's protocol ID
- 984-2566-IRB1
- Other IDs
- Si 034/2024
- Acronym
- HCV-aMAP
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request, subject to approval by the investigators and applicable institutional and ethical regulations.
Publications
de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21.
PubMed 32707225
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Risk of Hepatic Decompensation and Hepatocellular Carcinoma in Advanced Fibrotic or Cirrhotic Patients With Chronic Hepatitis C After Sustained Virologic Response
- ClinicalTrials.gov ID
- NCT07687758
- Acronym / sponsor ID
- HCV-aMAP / 984-2566-IRB1
- Conditions
- Hepatitis C Virus Infection, Compensated Advanced Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
- Keywords
- Sustained Virological Response, Direct-acting Antiviral Therapy, aMAP Score, FIB-4, APRI, ALBI Score, HCC Surveillance, Risk Stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 7 Jul 2026 (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 retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Patients treated at Siriraj Hospital between 2013 and 2023 were included if they had compensated advanced chronic liver disease and documented SVR12. The study compared FIB-4, APRI, ALBI, and aMAP scores calculated at SVR12 for prediction of hepatocellular carcinoma during long-term follow-up. The primary aim was to identify a very-low-risk subgroup in whom hepatocellular carcinoma surveillance might potentially be de-escalated.
Detailed description
This was a single-center retrospective cohort study conducted at Siriraj Hospital, Thailand. Consecutive adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated interferon-free sofosbuvir-based direct-acting antiviral therapy between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion were included. Compensated advanced chronic liver disease was defined according to Baveno VII criteria, including histologic F3/F4 fibrosis, vibration-controlled transient elastography greater than 10 kPa, or clinical evidence of portal hypertension.
Baseline demographic, clinical, laboratory, and transient elastography data were collected from electronic medical records. The FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12. Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy, failure to achieve SVR12, or incomplete medical records precluding outcome assessment were excluded.
The primary outcome was de novo hepatocellular carcinoma during follow-up. Predictive performance of the non-invasive scores was assessed using time-to-event analysis, Kaplan-Meier methods, Cox proportional hazards regression, and time-dependent receiver operating characteristic curves at 1, 3, 5, and 8 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV-related cACLD After SVR | – | Other: Non-invasive Risk Score AssessmentAdults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response at 12 weeks after sofosbuvir-based direct-acting antiviral therapy and were followed for de novo hepatocellular carcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated sofosbuvir-based direct-acting antiviral therapy at Siriraj Hospital between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Chronic hepatitis C virus infection treated with direct-acting antiviral therapy
- Documented sustained virological response at 12 weeks after treatment completion
- Evidence of compensated advanced chronic liver disease before direct-acting antiviral therapy, defined by at least one of the following: histologic F3 or F4 fibrosis, vibration-controlled transient elastography >10 kPa, radiologic features compatible with advanced fibrosis or cirrhosis, or clinical or endoscopic evidence of portal hypertension
- Minimum follow-up of 12 months after sustained virological response
Key exclusion criteria (3 listed)
- Incomplete or missing medical records precluding outcome assessment
- Known or suspected hepatocellular carcinoma before initiating direct-acting antiviral therapy
- Failure to achieve sustained virological response at 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Risk Score AssessmentFIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12 to evaluate their performance for predicting de novo hepatocellular carcinoma during follow-up. | Other | HCV-related cACLD After SVR |
Primary outcome
Development of de novo hepatocellular carcinoma
Time frame: From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.
Occurrence of newly diagnosed hepatocellular carcinoma after achievement of sustained virological response (SVR12). Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy were excluded.
4 secondary outcomes
Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma
Time frame: At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the APRI score for de novo hepatocellular carcinoma
Time frame: At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma
Time frame: At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma
Time frame: At 1, 3, 5, and 8 years after SVR12
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 7 Jul 2026.
- Background: PubMed 35120736de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Background: PubMed 32707225Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request, subject to approval by the investigators and applicable institutional and ethical regulations.
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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.
Tawesak Tanwandee, MD principal investigator
Siriraj Hospital
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 Virus Infection and Compensated Advanced Chronic Liver Disease, run by Siriraj Hospital at 1 site in Thailand.
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 5 inclusion and 3 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 7 Jul 2026. 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 Thailand. 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?
Development of de novo hepatocellular carcinoma (time frame: From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.). 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 NCT07687758, which also lists 2 linked publications.
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 7 Jul 2026.