Liver DiseasesGOVaSViRNCT04191018
GastrOesophageal Varices After Sustained Virological Response
An observational study of Liver Diseases and Hepatitis C, run by Oswaldo Cruz Foundation at 2 sites in Brazil.
Trial summary
Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Diseases, Hepatitis C
- What is being tested?
- Liver elastography, Splenic elastography and Gastrointestinal endoscopy
- How many people
- 322 participants
- Where
- 2 sitesBrazil
- Study dates
- 26 Nov 2019to 28 Feb 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced fibrosis or cirrhosis with sustained virologic response by direct-acting agents for HCV treatment
Who may be able to join
- Age ≥ 18 years
- Presence of advanced fibrosis or cirrhosis (stage F≥3 METAVIR) based on liver stiffness by transient elastography (≥ 9,5 kPa) or liver biopsy
- Gastrointestinal endoscopy at least 24 months before start of direct-acting agents for HCV treatment
- Liver stiffness measurement at least 18 months after SVR
Who cannot join
- Autoimmune hepatitis, hepatosplenic schistosomiasis or cholestasis diseases
- Liver transplantation
- Presence of high volume ascites or hepatocellular carcinoma
- Participation in programs of esophageal band ligation for eradication of esophageal varices
- Presence of signs of acute decompensated liver disease
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Evandro Chagas National Institute of Infectious Diseases
Rio de Janeiro, Rio de Janeiro/RJ, 21040-360
Hugo Perazzo, PhD, +5521 3865-9587, hugo.perazzo@ini.fiocruz.br
- Recruiting
Bonsucesso Federal Hospital
Rio de Janeiro, 21041-030
Gustavo Pereira, PhD, ghspereira@gmail.com
Flavia Fernandes, PhD, ffernandes.flavia@gmail.com
About this study
Official title: Progression of Gastroesophageal Varices After Sustained Virological Response by Interferon-free Regimens in Patients With Advanced Fibrosis / Cirrhosis Due to Chronic Hepatitis C
Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Oesophageal varices (OV) might be present in up to 40% of patients with liver cirrhosis have and the mortality rates from bleeding might be up to 20% per episode. Early diagnosis of advanced fibrosis/cirrhosis associated with hepatitis C treatment are key features for preventive and therapeutic measures to reduce liver-related mortality in HCV-infected patients.
Liver elastography is a high accurate non-invasive test for diagnosis of advanced fibrosis/cirrhosis. Few different methods of liver elastography are currently available: transient elastography by Fibroscan and ultrasound elastography by point-shear wave (p-SWE) and 2D-shear wave (2D-SWE). Gastrointestinal endoscopy (GIE) has been considered the gold standard for screening or surveillance of esophageal varices. More recently, international guidelines have been recommending the use of non-invasive methods to indicate or avoid OV screening: Baveno VI guidelines proposed that compensated cirrhotic patients with a liver stiffness measurement (LSM) by transient elastography <20kPa and a platelet count >150,000/μL can avoid screening endoscopy. The use of direct-acting agents (DAAs) has revolutionized the treatment of chronic hepatitis C with high effectiveness shown using all-oral interferon-free regimens. HCV cure, sustained virological response (SVR), has been associated with lower rates of liver-related complications, increase in quality of life and decrease in waiting-list registrations for liver transplantation in patients with chronic hepatitis C. Preliminary studies have been reporting significant regression liver stiffness after SVR. However, it is unclear whether SVR might decrease portal hypertension leading to OV regression and a reduced risk of variceal bleeding. In addition, the use of non-invasive methods to avoid OV screening must be validated in HCV patients after SVR. The aims of this cross-sectional study with prospective inclusion of patients will be: (i) to evaluate the impact of SVR in portal hypertension in HCV patients with advanced fibrosis/liver cirrhosis treated by interferon-free regimens and (ii) to validate non-invasive methods to avoid OV screening by GIE
- Conditions
- Liver Diseases, Hepatitis C
- Being tested
- Liver elastography, Splenic elastography, Gastrointestinal endoscopy
- Keywords
- sustained virological response, portal hypertension, cirrhosis, gastrointestinal endoscopy
- Medical subject headings
- Liver Diseases, Hepatitis C, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver elastographyDiagnostic test
Also called transient elastography (Fibroscan), 2D-shear wave (GE Healthcare), point-shear wave (Phillips)
Liver stiffness measurement
Splenic elastographyDiagnostic test
Also called transient elastography (Fibroscan), 2D-shear wave (GE Healthcare), point-shear wave (Phllips)
Splenic stiffness measurement
Gastrointestinal endoscopyDiagnostic test
Also called esophagogastroduodenoscopy
Gastrointestinal endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of esophageal varices (portal hypertension) after SVR
Evaluation of presence/absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis compared to before treatment
Measured: up to 48 months after SVR
Validation of the Baveno's criteria to avoid gastrointestinal endoscopy for screening of esophageal varices after SVR
Validation of the diagnostic performance of non-invasive tests (liver and splenic stiffness or biological markers) to screen esophageal varices in patients with advanced fibrosis/cirrhosis after SVR by DAA treatment for HCV
Measured: up to 48 months after SVR
Secondary outcomes (1)
Incidence of regression of esophageal varices after SVR
Evaluation of absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis and esophageal varices before treatment
Measured: up to 48 months after SVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start26 Nov 2019 (estimated)
- Primary completion14 Aug 2022 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Perazzo, PhD, Principal investigator, Oswaldo Cruz Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191018
- Sponsor's protocol ID
- 10320319.6.0000.5262
- Acronym
- GOVaSViR
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Gastroesophageal Varices After Sustained Virological Response by Interferon-free Regimens in Patients With Advanced Fibrosis / Cirrhosis Due to Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT04191018
- Acronym / sponsor ID
- GOVaSViR / 10320319.6.0000.5262
- Conditions
- Liver Diseases, Hepatitis C
- Keywords
- sustained virological response, portal hypertension, cirrhosis, gastrointestinal endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Study start
- 26 Nov 2019 (estimated)
- Primary completion
- 14 Aug 2022 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 9 Dec 2019 (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.
Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Oesophageal varices (OV) might be present in up to 40% of patients with liver cirrhosis have and the mortality rates from bleeding might be up to 20% per episode. Early diagnosis of advanced fibrosis/cirrhosis associated with hepatitis C treatment are key features for preventive and therapeutic measures to reduce liver-related mortality in HCV-infected patients.
Liver elastography is a high accurate non-invasive test for diagnosis of advanced fibrosis/cirrhosis. Few different methods of liver elastography are currently available: transient elastography by Fibroscan and ultrasound elastography by point-shear wave (p-SWE) and 2D-shear wave (2D-SWE). Gastrointestinal endoscopy (GIE) has been considered the gold standard for screening or surveillance of esophageal varices. More recently, international guidelines have been recommending the use of non-invasive methods to indicate or avoid OV screening: Baveno VI guidelines proposed that compensated cirrhotic patients with a liver stiffness measurement (LSM) by transient elastography <20kPa and a platelet count >150,000/μL can avoid screening endoscopy. The use of direct-acting agents (DAAs) has revolutionized the treatment of chronic hepatitis C with high effectiveness shown using all-oral interferon-free regimens. HCV cure, sustained virological response (SVR), has been associated with lower rates of liver-related complications, increase in quality of life and decrease in waiting-list registrations for liver transplantation in patients with chronic hepatitis C. Preliminary studies have been reporting significant regression liver stiffness after SVR. However, it is unclear whether SVR might decrease portal hypertension leading to OV regression and a reduced risk of variceal bleeding. In addition, the use of non-invasive methods to avoid OV screening must be validated in HCV patients after SVR. The aims of this cross-sectional study with prospective inclusion of patients will be: (i) to evaluate the impact of SVR in portal hypertension in HCV patients with advanced fibrosis/liver cirrhosis treated by interferon-free regimens and (ii) to validate non-invasive methods to avoid OV screening by GIE
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced fibrosis or cirrhosis with sustained virologic response by direct-acting agents for HCV treatment
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Presence of advanced fibrosis or cirrhosis (stage F≥3 METAVIR) based on liver stiffness by transient elastography (≥ 9,5 kPa) or liver biopsy
- Gastrointestinal endoscopy at least 24 months before start of direct-acting agents for HCV treatment
- Liver stiffness measurement at least 18 months after SVR
Key exclusion criteria (5 listed)
- Autoimmune hepatitis, hepatosplenic schistosomiasis or cholestasis diseases
- Liver transplantation
- Presence of high volume ascites or hepatocellular carcinoma
- Participation in programs of esophageal band ligation for eradication of esophageal varices
- Presence of signs of acute decompensated liver disease
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 |
|---|---|---|
| Liver elastographyAlso: transient elastography (Fibroscan), 2D-shear wave (GE Healthcare), point-shear wave (Phillips)Liver stiffness measurement | Diagnostic test | – |
| Splenic elastographyAlso: transient elastography (Fibroscan), 2D-shear wave (GE Healthcare), point-shear wave (Phllips)Splenic stiffness measurement | Diagnostic test | – |
| Gastrointestinal endoscopyAlso: esophagogastroduodenoscopyGastrointestinal endoscopy | Diagnostic test | – |
Primary outcome
Incidence of esophageal varices (portal hypertension) after SVR
Time frame: up to 48 months after SVR
Evaluation of presence/absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis compared to before treatment
Validation of the Baveno's criteria to avoid gastrointestinal endoscopy for screening of esophageal varices after SVR
Time frame: up to 48 months after SVR
Validation of the diagnostic performance of non-invasive tests (liver and splenic stiffness or biological markers) to screen esophageal varices in patients with advanced fibrosis/cirrhosis after SVR by DAA treatment for HCV
1 secondary outcome
Incidence of regression of esophageal varices after SVR
Time frame: up to 48 months after SVR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
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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.
Hugo Perazzo, PhD principal investigator
Oswaldo Cruz Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Hepatitis C, run by Oswaldo Cruz Foundation at 2 sites in Brazil.
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 4 inclusion and 5 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 Hugo Perazzo, PhD (+5521 3865-9587, hugo.perazzo@ini.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of esophageal varices (portal hypertension) after SVR (time frame: up to 48 months after SVR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2019.