Liver CirrhosisNCT01720238
Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
An observational study of Liver Cirrhosis and Hepatitis B, run by Beijing Friendship Hospital at 8 sites in China.
Trial summary
Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Hepatitis B
- What is being tested?
- Entecavir and Lamivudine plus Adefovir Dipivoxil
- How many people
- 621 participants
- Where
- 8 sitesChina
- Study dates
- Mar 2012to Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: compensated HBV Related liver cirrhosis
Who may be able to join
- written informed consent
- aged 18-70 years
- clinical diagnosis of compensated liver cirrhosis
- liver biopsy showing cirrhosis
- endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
- if no biopsy or endoscopy ，should meet two of the four:
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- Imaging(US, CT or MRI, et al) showing Surface nodularity： Echogenecity （spleen pachydiameter > 4.0cm or> 5 costal region）
- PLT < 100×10 < 9 >/L，no other interpretation
- ALB < 35.0 g/L, or INR > 1.3, or CHE < 5.0KU/L
- Liver stiffness measurement value > 12.4 kpa
- HBeAg(+)with HBVDNA > 10 < 3 > IU/mL or HBeAg(-) wtih HBVDNA > 102 IU/mL
Who cannot join
- patient with decompensated liver cirrhosis:presence of ascites, variceal hemorrhage,hepatic encephalopathy
- allergic to any ingredients of the drugs
- patient complicated with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease.
- AFP > 100ng/ml or Cr > 1.5×ULN
- pregnant woman
- patient with severe disease or other organ failure
Show all 9Show fewer
- patient with any tumors
- patient with sever mental disease.
- patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Beijing 302 Hospital
Beijing, Beijing Municipality
Beijing Ditan Hospital
Beijing, Beijing Municipality
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Beijing YouAn Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
PeKing University People's Hopital
Beijing, Beijing Municipality
The First Hospital of Peking University
Beijing, Beijing Municipality
About this study
Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.
- Conditions
- Liver Cirrhosis, Hepatitis B
- Being tested
- Entecavir, Lamivudine plus Adefovir Dipivoxil
- Keywords
- Compensated Liver Cirrhosis, Early Antiviral Therapy, Cost Effectiveness
- Medical subject headings
- Liver Cirrhosis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Baraclude, other manufacturers
0.5mg qd
Lamivudine plus Adefovir DipivoxilDrug
Also called Heptodin, other manufactures
Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Entecavir Therapy Receives: Drug: Entecavir | |
| Group 2 | Lamivudine plus Adefovir Dipivoxil Therapy Receives: Drug: Lamivudine plus Adefovir Dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decompensation rate of liver cirrhosis
presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC
Measured: 3 years
Secondary outcomes (5)
child-pugh score
Measured: 1,2 and 3 years
HBVDNA undetected
Measured: 1,2 and 3 years
liver elasticity
Measured: 1, 2, and 3 years
life quality score
Measured: 1, 2 and 3 years
cost-effectiveness
Measured: 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Beijing YouAn Hospital, Beijing Tiantan Hospital, Beijing Ditan Hospital, Peking Union Medical College Hospital, Beijing 302 Hospital
- Responsible party
- Principal investigator, Jia Ji-Dong, Beijing Friendship Hospital
- Investigators
- Dong Ji Jia, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720238
- Sponsor's protocol ID
- D1211000039120003
- Status last verified
- Jul 2015
- First submitted
- 31 Oct 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.
PubMed 33460002
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01720238
- Acronym / sponsor ID
- D1211000039120003
- Conditions
- Liver Cirrhosis, Hepatitis B
- Keywords
- Compensated Liver Cirrhosis, Early Antiviral Therapy, Cost Effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Beijing YouAn Hospital, Beijing Tiantan Hospital, Beijing Ditan Hospital, Peking Union Medical College Hospital, Beijing 302 Hospital
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Nov 2012 (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.
Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EntecavirEntecavir Therapy |
| Group 2 | – | Drug: Lamivudine plus Adefovir DipivoxilLamivudine plus Adefovir Dipivoxil Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- compensated HBV Related liver cirrhosis
Key inclusion criteria (11 listed)
- written informed consent
- aged 18-70 years
- clinical diagnosis of compensated liver cirrhosis
- HBeAg(+)with HBVDNA > 10 < 3 > IU/mL or HBeAg(-) wtih HBVDNA > 102 IU/mL
Key exclusion criteria (9 listed)
- patient with decompensated liver cirrhosis:presence of ascites, variceal hemorrhage,hepatic encephalopathy
- allergic to any ingredients of the drugs
- patient complicated with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease.
- AFP > 100ng/ml or Cr > 1.5×ULN
- pregnant woman
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 |
|---|---|---|
| EntecavirAlso: Baraclude, other manufacturers0.5mg qd | Drug | Group 1 |
| Lamivudine plus Adefovir DipivoxilAlso: Heptodin, other manufacturesLamivudine:100mg qd Adefovir Dipivoxil:10mg qd | Drug | Group 2 |
Primary outcome
Decompensation rate of liver cirrhosis
Time frame: 3 years
presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC
5 secondary outcomes
child-pugh score
Time frame: 1,2 and 3 years
HBVDNA undetected
Time frame: 1,2 and 3 years
liver elasticity
Time frame: 1, 2, and 3 years
life quality score
Time frame: 1, 2 and 3 years
cost-effectiveness
Time frame: 1, 2 and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 33460002Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.
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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.
Dong Ji Jia, Doctor principal investigator
Beijing Friendship Hospital
8 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 Cirrhosis and Hepatitis B, run by Beijing Friendship Hospital at 8 sites 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 11 inclusion and 9 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 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
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?
Decompensation rate of liver cirrhosis (time frame: 3 years). 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 NCT01720238, which also lists 1 linked publication.
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 28 Jul 2015.