Hepatitis C, ChronicNCT04460157
Prediction of Liver-related Outcomes After HCV Cure
An observational study of Hepatitis C, Chronic and Sustained Virological Response, run by Hospital Universitario de Valme at 1 site in Spain.
Trial summary
Objectives: To develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals (DAA)-based therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Sustained Virological Response, Direct-acting Antivirals
- How many people
- 1,035 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to 31 Dec 2021
- How long will I take part?
- 10 Years
- 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: HIV/HCV-coinfected and HCV-monoinfected individuals from two parallel cohorts (HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003; GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Subjects were included if they fulfilled the inclusion criteria.
Who may be able to join
- Had achieved SVR 12 weeks after DAA-based regimen, either with or without Peg-interferon
- Showed liver stiffness (LS) value ≥9.5 kPa prior to treatment
- Had LS measurement available at SVR time-point
Who cannot join
- Individuals seropositive for HBsAg
- Individuals who refuse to participate
- Individuals under 18 years old
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Valme
Seville, 41014
ANAIS CORMA-GOMEZ, MD, 0034955015799, anais.corgo@gmail.com
ANAIS CORMA-GOMEZ, MD
About this study
Official title: Development of a Predictive Model of Liver Complications Emergence in Patients With Advanced Fibrosis Who Achieve Sustained Virological Response With Direct-acting Antivirals-based Therapy
Objectives: To develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals (DAA)-based therapy.
Methods:
Read more
Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients who fullfilled the following inclusion criteria are included in this study: 1) Have received a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of treatment.
Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a common protocol every six months. At every visit, clinical and laboratory examination focusing on the early detection of liver complications are carried out. LS is assessed by vibration-controlled transient elastography, according to a standardized procedure, every 12 months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein determination are conducted for hepatocellular carcinoma screening, every six months.
Variables and data analysis: The primary outcome variable of the study will be the emergence of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver transplant. Predictive models will be develop with clinical, analytical, and genetic variables independently associated with the primary variable in a Cox regression for competitive risks applied to a developmental subpopulation. The performance of the model will be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive values will be calculated, both in the developmental population and in a validation population.
- Conditions
- Hepatitis C, Chronic, Sustained Virological Response, Direct-acting Antivirals, Hepatocellular Carcinoma, Hepatic Decompensation
- Medical subject headings
- Hepatitis C, Chronic, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver complications emergence
Appearance of hepatocellular carcinoma, portal hypertensive gastrointestinal bleeding, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorrenal syndrome and acute on chronic liver failure after SVR
Measured: From the inclusion until death, liver transplant, HCV reinfection or the censoring date (final study date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study startOct 2011
- Primary completion31 May 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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, ChronicStudies 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
- Prospective
- Enrolment
- 1,035 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Valme
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Anais Corma-Gomez, Hospital Universitario de Valme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460157
- Sponsor's protocol ID
- GEHEP-011
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gonzalez-Serna A, Corma-Gomez A, Cano M, Rubio-Sanchez R, Martin-Sierra C, Rincon P, Martin-Carmona J, Perez M, Pineda JA, Real LM, Macias J. Influence of Cellular Aging on Liver Stiffness in Patients With Hepatitis C Virus Achieving Sustained Viral Response. J Infect Dis. 2025 Jun 2;231(5):e846-e852. doi: 10.1093/infdis/jiaf087.
PubMed 39970137Martin-Carmona J, Corma-Gomez A, Tellez F, Arenga-Barrios D, Serrano-Fuentes M, Morano L, Corona-Mata D, Navarrete Lorite MN, Vera-Mendez FJ, Alados JC, Palacios R, de Los Santos I, Geijo P, Imaz A, Merino D, Reus-Banuls SJ, Galindo MJ, Lopez-Ruz MA, Galera C, Pineda JA, Macias J. No Impact of HIV Coinfection on Mortality in Patients With Hepatitis C Virus Infection After Sustained Virological Response. Clin Infect Dis. 2025 Apr 30;80(4):835-841. doi: 10.1093/cid/ciae473.
PubMed 39293030
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Predictive Model of Liver Complications Emergence in Patients With Advanced Fibrosis Who Achieve Sustained Virological Response With Direct-acting Antivirals-based Therapy
- ClinicalTrials.gov ID
- NCT04460157
- Acronym / sponsor ID
- GEHEP-011
- Conditions
- Hepatitis C, Chronic, Sustained Virological Response, Direct-acting Antivirals, Hepatocellular Carcinoma, Hepatic Decompensation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,035 participants (estimated)
- Lead sponsor
- Hospital Universitario de ValmeUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Oct 2011 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Jul 2020 (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.
Objectives: To develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals (DAA)-based therapy.
Methods:
Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients who fullfilled the following inclusion criteria are included in this study: 1) Have received a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of treatment.
Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a common protocol every six months. At every visit, clinical and laboratory examination focusing on the early detection of liver complications are carried out. LS is assessed by vibration-controlled transient elastography, according to a standardized procedure, every 12 months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein determination are conducted for hepatocellular carcinoma screening, every six months.
Variables and data analysis: The primary outcome variable of the study will be the emergence of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver transplant. Predictive models will be develop with clinical, analytical, and genetic variables independently associated with the primary variable in a Cox regression for competitive risks applied to a developmental subpopulation. The performance of the model will be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive values will be calculated, both in the developmental population and in a validation population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV/HCV-coinfected and HCV-monoinfected individuals from two parallel cohorts (HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003; GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Subjects were included if they fulfilled the inclusion criteria.
Key inclusion criteria (3 listed)
- Had achieved SVR 12 weeks after DAA-based regimen, either with or without Peg-interferon
- Showed liver stiffness (LS) value ≥9.5 kPa prior to treatment
- Had LS measurement available at SVR time-point
Key exclusion criteria (3 listed)
- Individuals seropositive for HBsAg
- Individuals who refuse to participate
- Individuals under 18 years old
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
Liver complications emergence
Time frame: From the inclusion until death, liver transplant, HCV reinfection or the censoring date (final study date)
Appearance of hepatocellular carcinoma, portal hypertensive gastrointestinal bleeding, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorrenal syndrome and acute on chronic liver failure after SVR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 39970137Gonzalez-Serna A, Corma-Gomez A, Cano M, Rubio-Sanchez R, Martin-Sierra C, Rincon P, Martin-Carmona J, Perez M, Pineda JA, Real LM, Macias J. Influence of Cellular Aging on Liver Stiffness in Patients With Hepatitis C Virus Achieving Sustained Viral Response. J Infect Dis. 2025 Jun 2;231(5):e846-e852. doi: 10.1093/infdis/jiaf087.
- Derived from this study: PubMed 39293030Martin-Carmona J, Corma-Gomez A, Tellez F, Arenga-Barrios D, Serrano-Fuentes M, Morano L, Corona-Mata D, Navarrete Lorite MN, Vera-Mendez FJ, Alados JC, Palacios R, de Los Santos I, Geijo P, Imaz A, Merino D, Reus-Banuls SJ, Galindo MJ, Lopez-Ruz MA, Galera C, Pineda JA, Macias J. No Impact of HIV Coinfection on Mortality in Patients With Hepatitis C Virus Infection After Sustained Virological Response. Clin Infect Dis. 2025 Apr 30;80(4):835-841. doi: 10.1093/cid/ciae473.
- 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.
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, Chronic and Sustained Virological Response, run by Hospital Universitario de Valme at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anais Corma-Gomez, MD (955015799, anais.corgo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver complications emergence (time frame: From the inclusion until death, liver transplant, HCV reinfection or the censoring date (final study date)). 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 NCT04460157, 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 2020.