Liver InjuryLISHBVNCT02808299
Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection
An observational study of Liver Injury and Hepatitis B Virus Infection History, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Injury, Hepatitis B Virus Infection History
- What is being tested?
- HBV infection history
- Type of treatment
- Vaccines
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosied as coronary heart disease (CHD) at hospitalization receive long-term statin treatment, with or without HBV infection history.
Who may be able to join
- patients with CHD receive long-term statin treatment
Who cannot join
- ALT is over ULN at baseline
- infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus
- triglyceride is over 4.5 mmol/L
- decompensated liver cirrhosis (Child B or C)
- active stage of HBV
- infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease
Show all 10Show fewer
- congestive heart failure
- malignant tumor
- autoimmune disease
- receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection
The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.
- Conditions
- Liver Injury, Hepatitis B Virus Infection History
- Being tested
- HBV infection history
- Keywords
- statin, hepatitis B virus
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV infection historyOther
Also called HBV carriers
HBV infection history or HBV carriers
| Study group | Role | What they receive |
|---|---|---|
| all the antigen and antibody of HBV are negative | Hepatitis B Virus surface antigen (HBsAg), Hepatitis B Virus surface antibody (HBsAb), Hepatitis B Virus e antigen (HBeAg), Hepatitis B Virus e antibody (HBeAb), Hepatitis B Virus core antibody (HBcAb) are all negative. | |
| HBV infection history | One or more of HBsAb,HBeAb, HBcAb are positive, while HBsAg and HBeAg are negative. If only HBsAb is positive, the history of HBV vaccination need to be excluded. Receives: Other: HBV infection history | |
| HBV carriers | One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not. Receives: Other: HBV infection history |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of alanine transaminase (ALT, U/L)
The peak increases of ALT from baseline to follow-up
Measured: one month, three months, six months
number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
Measured: one month, three months, six months
Secondary outcomes (1)
number of participants with alanine transaminase (ALT) increasing over the ULN
Measured: one month, three months, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver InjuryStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing 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
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijian Yang, Doctor, Study chair, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808299
- Sponsor's protocol ID
- StatinsHBV-1
- Acronym
- LISHBV
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Publications
Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. doi: 10.1161/01.CIR.0000131519.15067.1f.
PubMed 15198967Ekstedt M, Franzen LE, Mathiesen UL, Holmqvist M, Bodemar G, Kechagias S. Statins in non-alcoholic fatty liver disease and chronically elevated liver enzymes: a histopathological follow-up study. J Hepatol. 2007 Jul;47(1):135-41. doi: 10.1016/j.jhep.2007.02.013. Epub 2007 Mar 8.
PubMed 17400325Segarra-Newnham M, Parra D, Martin-Cooper EM. Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy. 2007 Jun;27(6):845-51. doi: 10.1592/phco.27.6.845.
PubMed 17542767Balmer ML, Dufour JF. Treatment of hypercholesterolemia in patients with primary biliary cirrhosis might be more beneficial than indicated. Swiss Med Wkly. 2008 Jul 26;138(29-30):415-9. doi: 10.4414/smw.2008.12311.
PubMed 18654866Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. doi: 10.1016/j.amjcard.2005.12.014. Epub 2006 Feb 3.
PubMed 16581333Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.
PubMed 16496329Lu J, Zhou Y, Lin X, Jiang Y, Tian R, Zhang Y, Wu J, Zhang F, Zhang Y, Wang Y, Bi S. General epidemiological parameters of viral hepatitis A, B, C, and E in six regions of China: a cross-sectional study in 2007. PLoS One. 2009 Dec 24;4(12):e8467. doi: 10.1371/journal.pone.0008467.
PubMed 20041146Zhang Q, Yang Z. Can statins be used safely in coronary heart disease patients of hepatitis B virus carriers? Int J Cardiol. 2011 Jan 21;146(2):291. doi: 10.1016/j.ijcard.2010.10.087. Epub 2010 Dec 3. No abstract available.
PubMed 21129795
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection
- ClinicalTrials.gov ID
- NCT02808299
- Acronym / sponsor ID
- LISHBV / StatinsHBV-1
- Conditions
- Liver Injury, Hepatitis B Virus Infection History
- Keywords
- statin, hepatitis B virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2020 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- 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.
The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| all the antigen and antibody of HBV are negative | – | –Hepatitis B Virus surface antigen (HBsAg), Hepatitis B Virus surface antibody (HBsAb), Hepatitis B Virus e antigen (HBeAg), Hepatitis B Virus e antibody (HBeAb), Hepatitis B Virus core antibody (HBcAb) are all negative. |
| HBV infection history | – | Other: HBV infection historyOne or more of HBsAb,HBeAb, HBcAb are positive, while HBsAg and HBeAg are negative. If only HBsAb is positive, the history of HBV vaccination need to be excluded. |
| HBV carriers | – | Other: HBV infection historyOne or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosied as coronary heart disease (CHD) at hospitalization receive long-term statin treatment, with or without HBV infection history.
Key inclusion criteria (1 listed)
- patients with CHD receive long-term statin treatment
Key exclusion criteria (10 listed)
- ALT is over ULN at baseline
- infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus
- triglyceride is over 4.5 mmol/L
- decompensated liver cirrhosis (Child B or C)
- active stage of HBV
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 |
|---|---|---|
| HBV infection historyAlso: HBV carriersHBV infection history or HBV carriers | Other | HBV carriers, HBV infection history |
Primary outcome
changes of alanine transaminase (ALT, U/L)
Time frame: one month, three months, six months
The peak increases of ALT from baseline to follow-up
number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
Time frame: one month, three months, six months
1 secondary outcome
number of participants with alanine transaminase (ALT) increasing over the ULN
Time frame: one month, three months, six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Background: PubMed 15198967Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. doi: 10.1161/01.CIR.0000131519.15067.1f.
- Background: PubMed 17400325Ekstedt M, Franzen LE, Mathiesen UL, Holmqvist M, Bodemar G, Kechagias S. Statins in non-alcoholic fatty liver disease and chronically elevated liver enzymes: a histopathological follow-up study. J Hepatol. 2007 Jul;47(1):135-41. doi: 10.1016/j.jhep.2007.02.013. Epub 2007 Mar 8.
- Background: PubMed 17542767Segarra-Newnham M, Parra D, Martin-Cooper EM. Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy. 2007 Jun;27(6):845-51. doi: 10.1592/phco.27.6.845.
- Background: PubMed 18654866Balmer ML, Dufour JF. Treatment of hypercholesterolemia in patients with primary biliary cirrhosis might be more beneficial than indicated. Swiss Med Wkly. 2008 Jul 26;138(29-30):415-9. doi: 10.4414/smw.2008.12311.
- Background: PubMed 16581333Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. doi: 10.1016/j.amjcard.2005.12.014. Epub 2006 Feb 3.
- Background: PubMed 16496329Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.
- Background: PubMed 20041146Lu J, Zhou Y, Lin X, Jiang Y, Tian R, Zhang Y, Wu J, Zhang F, Zhang Y, Wang Y, Bi S. General epidemiological parameters of viral hepatitis A, B, C, and E in six regions of China: a cross-sectional study in 2007. PLoS One. 2009 Dec 24;4(12):e8467. doi: 10.1371/journal.pone.0008467.
- Results publication: PubMed 21129795Zhang Q, Yang Z. Can statins be used safely in coronary heart disease patients of hepatitis B virus carriers? Int J Cardiol. 2011 Jan 21;146(2):291. doi: 10.1016/j.ijcard.2010.10.087. Epub 2010 Dec 3. No abstract available.
- Click here for more information about this studyLink provided by the sponsor.
- Click here for more information about this studyLink provided by the sponsor.
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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.
Zhijian Yang, Doctor study chair
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province 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 Liver Injury and Hepatitis B Virus Infection History, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 1 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 21 Jun 2016. 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 China. 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 Zhijian Yang, Doctor (+83 13809030208, zhijianyangnj@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of alanine transaminase (ALT, U/L) (time frame: one month, three months, six months). 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?
On the ClinicalTrials.gov record for NCT02808299, which also lists 8 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 21 Jun 2016.