Portal HypertensionNCT04797910
Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis
An observational study of Portal Hypertension, run by Nanfang Hospital, Southern Medical University.
Trial summary
Complications associated with portal hypertension are the leading cause of death in patients with cirrhosis. Until now, hepatic venous pressure gradient (HVPG) - the difference between the wedged hepatic venous pressure (WHVP) and the free hepatic vein pressure (FHVP)- has been the criterion standard to determine… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Portal Hypertension
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2021to 31 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatitis B cirrhosis
Who may be able to join
- Patients with viral cirrhosis were diagnosed;
- Age 18-80 years;
- Need and willing to accept measure HVPG;
- First HVPG measurement of more than 5 mmHg;
- Signed Informed Consent
Who cannot join
- Patients with viral cirrhosis have been treated with antiviral therapy and have achieved virological response;
- Ready to accept or have accepted a TIPS procedure;
- Splenic embolization was performed;
- Inaccurate measurement of HVPG due to combined hepatic venous shunt;
- Complicated with alcoholic liver disease, autoimmune liver disease or other types of liver disease;
- Complicated with liver cancer or other organ malignancy;
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- Combined with severe cardiopulmonary disease affects survival;
- Complicated with severe renal insufficiency;
- Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis;
- Women who are planning to become pregnant or who are pregnant or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Complications associated with portal hypertension are the leading cause of death in patients with cirrhosis. Until now, hepatic venous pressure gradient (HVPG) - the difference between the wedged hepatic venous pressure (WHVP) and the free hepatic vein pressure (FHVP)- has been the criterion standard to determine portal pressure. Antiviral therapy may decrease HVPG which needs to be verified.
- Conditions
- Portal Hypertension
- Medical subject headings
- Hypertension, Portal
What is being measured
The primary outcome is the main question the study is designed to answer.
HVPG changed and reached the response standard
HVPG response to therapy indicates a decrease in HVPG of at least 10% from baseline or to less than 12 mmHg after chronic treatment with NSBBs.
Measured: one year
Secondary outcomes (1)
Antiviral therapy achieved a virological response
HBV-DNA remained undetectable for successive two times.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start10 Mar 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797910
- Sponsor's protocol ID
- NFEC-2021-002
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis
- ClinicalTrials.gov ID
- NCT04797910
- Acronym / sponsor ID
- NFEC-2021-002
- Conditions
- Portal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Mar 2021 (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.
Complications associated with portal hypertension are the leading cause of death in patients with cirrhosis. Until now, hepatic venous pressure gradient (HVPG) - the difference between the wedged hepatic venous pressure (WHVP) and the free hepatic vein pressure (FHVP)- has been the criterion standard to determine portal pressure. Antiviral therapy may decrease HVPG which needs to be verified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatitis B cirrhosis
Key inclusion criteria (5 listed)
- Patients with viral cirrhosis were diagnosed;
- Age 18-80 years;
- Need and willing to accept measure HVPG;
- First HVPG measurement of more than 5 mmHg;
- Signed Informed Consent
Key exclusion criteria (10 listed)
- Patients with viral cirrhosis have been treated with antiviral therapy and have achieved virological response;
- Ready to accept or have accepted a TIPS procedure;
- Splenic embolization was performed;
- Inaccurate measurement of HVPG due to combined hepatic venous shunt;
- Complicated with alcoholic liver disease, autoimmune liver disease or other types of 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.
Primary outcome
HVPG changed and reached the response standard
Time frame: one year
HVPG response to therapy indicates a decrease in HVPG of at least 10% from baseline or to less than 12 mmHg after chronic treatment with NSBBs.
1 secondary outcome
Antiviral therapy achieved a virological response
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension, run by Nanfang Hospital, Southern Medical University.
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 10 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 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaofeng Zhang (+86-18565552050, 1282614092@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HVPG changed and reached the response standard (time frame: one year). 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 15 Mar 2021.