Hepatitis BPhase 4NCT02417207
Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation
A Phase 4 study testing Entecavir combined long-term low-dose HBIG group intramuscular and Entecavir combined HBIG group short-term high-dose intravenous in people with Hepatitis B and Liver Transplantation, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Liver Transplantation
- What is being tested?
- Entecavir combined long-term low-dose HBIG group intramuscular and Entecavir combined HBIG group short-term high-dose intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Apr 2018
- Phase
- Phase 4
- 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
Who may be able to join
- correlation disease hepatitis B viral hepatitis liver transplantation recipients for the first time;
- older than 18 years old, men and women not limited;
- preoperative HbsAg positive, regardless of whether preoperative HBV DNA level, regardless of whether preoperative antiviral treatment, regardless of whether associated with primary liver cancer;
- donor HbsAg negative, other virology negative in liver conditions;
- to integrate research, good adherence.
Who cannot join
- overlap other types of viral hepatitis;
- the correlation of end-stage liver disease hepatitis b;
- again to liver transplantation, or joint organ transplantation;
- allergic to hepatitis b immune globulin;
- of primary hepatocellular carcinoma with vena cava, portal vein around the trunk or branch, hepatic vein and other large vascular invasion;
- ABO blood group incompatibility in liver transplantation;
- moderately severe renal insufficiency, serum creatinine 180 umol/L or higher;
- there has been a drug resistance of entecavir before liver transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.
Read the detailed description
At present, the prevention of hepatitis B recurrence after liver transplantation is the most commonly used scheme for nucleoside analogue combined hepatitis B immune globulin (HBIG). HBIG is a condensed to prevent the efficient price of invasion of hepatitis b immunoglobulin, its function is a direct and virus.Also it is to block the virus into liver cells. Lamivudine with HBIG therapy has hepatitis b recurrence rate reduced to below 10%, entecavir combined HBIG hepatitis b recurrence rate is low below 1%. In European and American countries, HBIG the most commonly used method for long-term high-dose intravenous drip, but our country is long-term low-dose intramuscular injection, but all need lifelong medication, for how long after surgery or which patients can disable or not HBIG no consensus. Whether long-term intravenous drip or intramuscular HBIG, are some disadvantages such as high cost, drug side effects, also brought inconvenience to patients. The advent of potent against hepatitis b virus drugs continuously under the background of, in recent years, scholars have already begun to no application or short-term application HBIG discontinuation to prevent hepatitis b recurrence after research, low before transplantation of hepatitis B virus(HBV) DNA replication, such as effective antiviral therapy of hepatitis b recurrence after after transplantation were created the conditions of no HBIG solution. Most studies suggest that transplantation of nucleoside analogues alone for a long time without application or short-term application of HBIG scheme to prevent hepatitis b recurrence is safe, but there are only several transplant center in study abroad, and the Chinese mainland for all application or short-term application of HBIG clinical studies. Entecavir with potent antiviral capacity and high genetic barrier to resistance, low incidence of drug resistance, is currently the prevention and treatment of hepatitis b recurrence after liver transplantation of first-line drugs, entecavir combined long-term muscle injection low-dose HBIG is at present our country is the most commonly used drug for liver transplantation in our center.
This study for entecavir combined after liver transplantation for short-term application type static note HBIG to prevent hepatitis b recurrence of prospective, multicenter, randomized, controlled experimental study, the equivalence. The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.
- Conditions
- Hepatitis B, Liver Transplantation
- Being tested
- Entecavir combined long-term low-dose HBIG group intramuscular, Entecavir combined HBIG group short-term high-dose intravenous
- Keywords
- hepatitis B immune globulin (HBIG), liver transplantation, hepatitis B, entecavir
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir combined long-term low-dose HBIG group intramuscularDrug
HBIG scheme is: the use of intraoperative muscle injection of 800 IU HBIG, postoperative week 1 intramuscular injection HBIG 400 IU 1 times a day, 1 week after intramuscular injection HBIG 400 IU 2 times per week, dosage and time interval according to the HBsAb drops in patients with degree of level adjustment, target drops for 3 months or more after 500 IU/mL, 3 ~ 6 months or 300 IU/mL, after six months of 100 IU/mL or more.
Entecavir combined HBIG group short-term high-dose intravenousDrug
Preoperative HBV DNA level is less than 1000 IU/ml, intraoperative intravenous drip of 2500 IU HBIG static note type, postoperative 1 and 15 days respectively to give 2500 IU HBIG static note type, a total of three times, then no longer apply. Preoperative HBV DNA level greater than 1000 IU/ml, the use of HBIG solution for: intraoperative intravenous drip of 5000 IU HBIG static note type, postoperative day 1, 15 days and 30 days respectively to give 2000-2500 IU HBIG static note type, a total of four times, since then no longer apply. Preoperative HBV DNA level of the unknown, preoperative immediate detection of DNA, intraoperative intravenous drip of 5000 iu HBIG static note type, choose according to test results after dosing frequency.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir combined long-term low-dose HBIG group intramuscular | Sham comparator | HBIG scheme is: the use of intraoperative muscle injection of 800 IU HBIG, postoperative week 1 intramuscular injection HBIG 400 IU 1 times a day, 1 week after intramuscular injection HBIG 400 IU 2 times per week, dosage and time interval according to the HBsAb drops in patients with degree of level adjustment, target drops for 3 months or more after 500 IU/mL, 3 ~ 6 months or 300 IU/mL, after six months of 100 IU/mL or more. Receives: Drug: Entecavir combined long-term low-dose HBIG group intramuscular |
| Entecavir combined HBIG group short-term high-dose intravenous | Active comparator | Preoperative HBV DNA level is less than 1000 IU/ml, intraoperative intravenous drip of 2500 IU HBIG static note type, postoperative 1 and 15 days respectively to give 2500 IU HBIG static note type, a total of three times, then no longer apply. Preoperative HBV DNA level greater than 1000 IU/ml, the use of HBIG solution for: intraoperative intravenous drip of 5000 IU HBIG static note type, postoperative day 1, 15 days and 30 days respectively to give 2000-2500 IU HBIG static note type, a total of four times, since then no longer apply. Preoperative HBV DNA level of the unknown, preoperative immediate detection of DNA, intraoperative intravenous drip of 5000 iu HBIG static note type, choose according to test results after dosing frequency. Receives: Drug: Entecavir combined HBIG group short-term high-dose intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatitis B recurrence after liver transplantation
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yang Yang, MD, Study chair, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417207
- Sponsor's protocol ID
- (2014)2-127
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation
- ClinicalTrials.gov ID
- NCT02417207
- Acronym / sponsor ID
- (2014)2-127
- Conditions
- Hepatitis B, Liver Transplantation
- Keywords
- hepatitis B immune globulin (HBIG), liver transplantation, hepatitis B, entecavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 15 Apr 2015 (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 observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.
Detailed description
At present, the prevention of hepatitis B recurrence after liver transplantation is the most commonly used scheme for nucleoside analogue combined hepatitis B immune globulin (HBIG). HBIG is a condensed to prevent the efficient price of invasion of hepatitis b immunoglobulin, its function is a direct and virus.Also it is to block the virus into liver cells. Lamivudine with HBIG therapy has hepatitis b recurrence rate reduced to below 10%, entecavir combined HBIG hepatitis b recurrence rate is low below 1%. In European and American countries, HBIG the most commonly used method for long-term high-dose intravenous drip, but our country is long-term low-dose intramuscular injection, but all need lifelong medication, for how long after surgery or which patients can disable or not HBIG no consensus. Whether long-term intravenous drip or intramuscular HBIG, are some disadvantages such as high cost, drug side effects, also brought inconvenience to patients. The advent of potent against hepatitis b virus drugs continuously under the background of, in recent years, scholars have already begun to no application or short-term application HBIG discontinuation to prevent hepatitis b recurrence after research, low before transplantation of hepatitis B virus(HBV) DNA replication, such as effective antiviral therapy of hepatitis b recurrence after after transplantation were created the conditions of no HBIG solution. Most studies suggest that transplantation of nucleoside analogues alone for a long time without application or short-term application of HBIG scheme to prevent hepatitis b recurrence is safe, but there are only several transplant center in study abroad, and the Chinese mainland for all application or short-term application of HBIG clinical studies. Entecavir with potent antiviral capacity and high genetic barrier to resistance, low incidence of drug resistance, is currently the prevention and treatment of hepatitis b recurrence after liver transplantation of first-line drugs, entecavir combined long-term muscle injection low-dose HBIG is at present our country is the most commonly used drug for liver transplantation in our center.
This study for entecavir combined after liver transplantation for short-term application type static note HBIG to prevent hepatitis b recurrence of prospective, multicenter, randomized, controlled experimental study, the equivalence. The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir combined long-term low-dose HBIG group intramuscular | Sham comparator | Drug: Entecavir combined long-term low-dose HBIG group intramuscularHBIG scheme is: the use of intraoperative muscle injection of 800 IU HBIG, postoperative week 1 intramuscular injection HBIG 400 IU 1 times a day, 1 week after intramuscular injection HBIG 400 IU 2 times per week, dosage and time interval according to the HBsAb drops in patients with degree of level adjustment, target drops for 3 months or more after 500 IU/mL, 3 ~ 6 months or 300 IU/mL, after six months of 100 IU/mL or more. |
| Entecavir combined HBIG group short-term high-dose intravenous | Active comparator | Drug: Entecavir combined HBIG group short-term high-dose intravenousPreoperative HBV DNA level is less than 1000 IU/ml, intraoperative intravenous drip of 2500 IU HBIG static note type, postoperative 1 and 15 days respectively to give 2500 IU HBIG static note type, a total of three times, then no longer apply. Preoperative HBV DNA level greater than 1000 IU/ml, the use of HBIG solution for: intraoperative intravenous drip of 5000 IU HBIG static note type, postoperative day 1, 15 days and 30 days respectively to give 2000-2500 IU HBIG static note type, a total of four times, since then no longer apply. Preoperative HBV DNA level of the unknown, preoperative immediate detection of DNA, intraoperative intravenous drip of 5000 iu HBIG static note type, choose according to test results after dosing frequency. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- correlation disease hepatitis B viral hepatitis liver transplantation recipients for the first time;
- older than 18 years old, men and women not limited;
- preoperative HbsAg positive, regardless of whether preoperative HBV DNA level, regardless of whether preoperative antiviral treatment, regardless of whether associated with primary liver cancer;
- donor HbsAg negative, other virology negative in liver conditions;
- to integrate research, good adherence.
Key exclusion criteria (8 listed)
- overlap other types of viral hepatitis;
- the correlation of end-stage liver disease hepatitis b;
- again to liver transplantation, or joint organ transplantation;
- allergic to hepatitis b immune globulin;
- of primary hepatocellular carcinoma with vena cava, portal vein around the trunk or branch, hepatic vein and other large vascular invasion;
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 |
|---|---|---|
| Entecavir combined long-term low-dose HBIG group intramuscularHBIG scheme is: the use of intraoperative muscle injection of 800 IU HBIG, postoperative week 1 intramuscular injection HBIG 400 IU 1 times a day, 1 week after intramuscular injection HBIG 400 IU 2 times per week, dosage and time interval according to the HBsAb drops in patients with degree of level adjustment, target drops for 3 months or more after 500 IU/mL, 3 ~ 6 months or 300 IU/mL, after six months of 100 IU/mL or more. | Drug | Entecavir combined long-term low-dose HBIG group intramuscular |
| Entecavir combined HBIG group short-term high-dose intravenousPreoperative HBV DNA level is less than 1000 IU/ml, intraoperative intravenous drip of 2500 IU HBIG static note type, postoperative 1 and 15 days respectively to give 2500 IU HBIG static note type, a total of three times, then no longer apply. Preoperative HBV DNA level greater than 1000 IU/ml, the use of HBIG solution for: intraoperative intravenous drip of 5000 IU HBIG static note type, postoperative day 1, 15 days and 30 days respectively to give 2000-2500 IU HBIG static note type, a total of four times, since then no longer apply. Preoperative HBV DNA level of the unknown, preoperative immediate detection of DNA, intraoperative intravenous drip of 5000 iu HBIG static note type, choose according to test results after dosing frequency. | Drug | Entecavir combined HBIG group short-term high-dose intravenous |
Primary outcome
hepatitis B recurrence after liver transplantation
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
Yang Yang, MD study chair
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir combined long-term low-dose HBIG group intramuscular and Entecavir combined HBIG group short-term high-dose intravenous in people with Hepatitis B and Liver Transplantation, run by Third Affiliated Hospital, Sun Yat-Sen 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 5 inclusion and 8 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 Apr 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Wang Guoying, MD (086-13632407313, wanggy3@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatitis B recurrence after liver transplantation (time frame: 2years). 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 Apr 2015.