Hepatitis BPhase 2STAPHNCT05483894
Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
A Phase 2 study testing Atorvastatin 10mg in people with Hepatitis B and Portal Hypertension, run by Samsung Medical Center.
Trial summary
To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Hepatitis B, Portal Hypertension
- What is being tested?
- Atorvastatin 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Jan 2025
- Phase
- Phase 2
- 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 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 19 and 69 years of age
- If HBsAg positivity has been observed for more than 6 months or a clinical history of chronic hepatitis B is confirmed
- When liver cirrhosis is diagnosed histologically, radiologically, or clinically (if one or more of A-D is applicable) A. When stage F4 fibrosis is confirmed by liver biopsy B. When splenomegaly is observed with morphological changes (surface nodularity and hypertrophy of the caudate lobe) appropriate for liver cirrhosis.
- If the platelet count is less than 100,000/mm3 in two consecutive tests D. When esophageal varices or gastric varices are confirmed by upper gastrointestinal endoscopy
- If the serum HBV DNA is well controlled to 2000 International Unit (IU)/mL or less while taking antiviral treatment
- When the splenic elasticity measured by two-dimensional shear wave elastography is greater than 25 kilopascal(kPa)
- When informed consent is possible
Who cannot join
- Hepatitis C or HIV co-infected person
- Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
- In case of decreased liver function with Child Pugh score of 7 or higher
- History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
- If there is a history of cancer (except for cases where there is no recurrence for 5 years after treatment due to early solid organ tumors (early gastric cancer, thyroid cancer))
- If there is a serious comorbidity whose life expectancy is estimated to be less than 3 years
Show all 11Show fewer
- In case of chronic kidney disease estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- If portal vein thrombosis is diagnosed
- Previous intrahepatic portal vein shunt intervention or liver transplantation
- A history of statin administration within the last 2 years
- In case of side effects from previous statin administration (drug-related hepatotoxicity, muscle toxicity, allergic reaction, etc.)
About this study
To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension
Read the detailed description
In order to derive a reliable correlation between statin use and the reduction of portal hypertension, it is necessary to proceed with a clinical study with a high level of evidence, such as a randomized controlled clinical trial study. In addition, previous small randomized controlled trials had a limitation in that patients with various causes of liver cirrhosis were included. In this study, only patients diagnosed with chronic hepatitis B and compensated cirrhosis who are taking antiviral treatment will be included in the study, and in patients whose viral activity are suppressed by taking antiviral treatment, it was investigated whether statin administration had a significant effect in additionally improving portal pressure. We want to prove it through a randomized controlled clinical trial study.
- Conditions
- Hepatitis B, Portal Hypertension
- Being tested
- Atorvastatin 10mg, Placebo
- Keywords
- Atorvastatin, HBV- Related Liver Cirrhosis, Portal Hypertension
- Medical subject headings
- Hepatitis B, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 10mgDrug
Also called Lipinon Tab. 10mg
Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group
PlaceboDrug
Placebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Atorvastatin 10mg once daily for 24 weeks Receives: Drug: Atorvastatin 10mg |
| Control group | Placebo comparator | Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks Receives: Drug: Atorvastatin 10mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group
A responder is defined as a case in which the percentage change in spleen stiffness decreased by 10% or more from baseline after 12 weeks of atorvastatin or placebo administration. When the ratio of the number of responders to the number of participants in each group is defined as the response rate, there is a difference in the response rates between the experimental group and the control group.
Measured: 12 weeks
Secondary outcomes (4)
Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group
After 12 weeks of atorvastatin administration, the response rate of the experimental group in which the percentage change in spleen stiffness decreased by 10% or more compared to the baseline value after 12 weeks of administration is different from the response rate after 24 weeks of the experimental group, in which the percentage change in spleen stiffness decreased by more than 10% compared to the baseline after 24 weeks of administration.
Measured: 24 weeks
Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group
The response rate after 12 weeks of placebo administration in the control group is different from the response rate after 24 weeks of atorvastatin administration in the experimental group.
Measured: 24 weeks
Response rate of 12 weeks of placebo in control group and 12 weeks of atorvastatin in control group
The response rate after 12 weeks of placebo administration in the control group is different from the response rate after 12 weeks of atorvastatin administration (24 weeks after the start of the study) in the control group at 12 weeks.
Measured: 12 weeks
Adverse events
Frequency of adverse events (hepatotoxicity, muscle toxicity) after atorvastatin administration
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Hyun Sinn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483894
- Sponsor's protocol ID
- SMC 2021-06-205-001
- Acronym
- STAPH
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05483894
- Acronym / sponsor ID
- STAPH / SMC 2021-06-205-001
- Conditions
- Hepatitis B, Portal Hypertension
- Keywords
- Atorvastatin, HBV- Related Liver Cirrhosis, Portal Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 2 Aug 2022 (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.
To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension
Detailed description
In order to derive a reliable correlation between statin use and the reduction of portal hypertension, it is necessary to proceed with a clinical study with a high level of evidence, such as a randomized controlled clinical trial study. In addition, previous small randomized controlled trials had a limitation in that patients with various causes of liver cirrhosis were included. In this study, only patients diagnosed with chronic hepatitis B and compensated cirrhosis who are taking antiviral treatment will be included in the study, and in patients whose viral activity are suppressed by taking antiviral treatment, it was investigated whether statin administration had a significant effect in additionally improving portal pressure. We want to prove it through a randomized controlled clinical trial study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Drug: Atorvastatin 10mgAtorvastatin 10mg once daily for 24 weeks |
| Control group | Placebo comparator | Drug: Atorvastatin 10mg, Drug: PlaceboPlacebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults between 19 and 69 years of age
- If HBsAg positivity has been observed for more than 6 months or a clinical history of chronic hepatitis B is confirmed
- When liver cirrhosis is diagnosed histologically, radiologically, or clinically (if one or more of A-D is applicable) A. When stage F4 fibrosis is confirmed by liver biopsy B. When splenomegaly is observed with morphological changes (surface nodularity and hypertrophy of the caudate lobe) appropriate for liver cirrhosis.
- If the serum HBV DNA is well controlled to 2000 International Unit (IU)/mL or less while taking antiviral treatment
- When the splenic elasticity measured by two-dimensional shear wave elastography is greater than 25 kilopascal(kPa)
Key exclusion criteria (11 listed)
- Hepatitis C or HIV co-infected person
- Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
- In case of decreased liver function with Child Pugh score of 7 or higher
- History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
- If there is a history of cancer (except for cases where there is no recurrence for 5 years after treatment due to early solid organ tumors (early gastric cancer, thyroid cancer))
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 |
|---|---|---|
| Atorvastatin 10mgAlso: Lipinon Tab. 10mgAtorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group | Drug | Control group, Experimental group |
| PlaceboPlacebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group | Drug | Control group |
Primary outcome
Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group
Time frame: 12 weeks
A responder is defined as a case in which the percentage change in spleen stiffness decreased by 10% or more from baseline after 12 weeks of atorvastatin or placebo administration. When the ratio of the number of responders to the number of participants in each group is defined as the response rate, there is a difference in the response rates between the experimental group and the control group.
4 secondary outcomes
Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group
Time frame: 24 weeks
Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group
Time frame: 24 weeks
Response rate of 12 weeks of placebo in control group and 12 weeks of atorvastatin in control group
Time frame: 12 weeks
Adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 10mg in people with Hepatitis B and Portal Hypertension, run by Samsung Medical Center.
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 7 inclusion and 11 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 2 Aug 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group (time frame: 12 weeks). 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 2 Aug 2022.