Liver TransplantationNCT01139203
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
A study testing lamivudine adefovir entecavir HBIG in people with Liver Transplantation and Hepatitis B, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Hepatitis B
- What is being tested?
- lamivudine adefovir entecavir HBIG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Dec 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients into the transplant waiting list with HBV-related liver disease.
- HBsAg-positive.
- serum HBV-DNA negative.
- no HCV, HDV and HIV co-infection.
- without renal dysfunction.
- No lamivudine, adefovir and entecavir drug allergy history.
- no HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Who cannot join
- patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
- HBsAg-negative.
- serum HBV-DNA positive.
- HCV, HDV and HIV co-infection.
- patients with severe renal dysfunction or failure.
- lamivudine, adefovir and entecavir drug allergy history.
- HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First People's Hospital
Shanghai, 200000
Zhi-Hai Peng, MD PHD, 0086-021-63240090 ext. 3132, pengpzh@hotmail.com
Tao Li, MD
About this study
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.
- Conditions
- Liver Transplantation, Hepatitis B
- Being tested
- lamivudine adefovir entecavir HBIG
- Keywords
- HBV recurrence, 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.
lamivudine adefovir entecavir HBIGDrug
lamivudine 100mg orally daily adefovir 10mg orally daily entecavir 0.5mg orally daily HBIG 2000 unit intravenously during the anhepatic phase,and followed 800 unit intramuscularly daily until day 14,then 400 unit intramuscularly twice weekly
| Study group | Role | What they receive |
|---|---|---|
| lamivudine | Active comparator | Not described Receives: Drug: lamivudine adefovir entecavir HBIG |
| lamivudine and adefovir | Active comparator | Not described Receives: Drug: lamivudine adefovir entecavir HBIG |
| entecavir | Active comparator | Not described Receives: Drug: lamivudine adefovir entecavir HBIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
serological markers of HBV
Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.
Measured: every three month after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Investigators
- Zhi-Hai Peng, MD PHD, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139203
- Sponsor's protocol ID
- SH20100601
- Status last verified
- Aug 2009
- First submitted
- 7 Jun 2010
- Last updated
- 28 Jun 2010
- Results posted
- No
Publications
Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32.
PubMed 19373086Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614.
PubMed 18825721Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. doi: 10.1093/ndt/gfm655.
PubMed 17890261Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599.
PubMed 19852566
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
- ClinicalTrials.gov ID
- NCT01139203
- Acronym / sponsor ID
- SH20100601
- Conditions
- Liver Transplantation, Hepatitis B
- Keywords
- HBV recurrence, entecavir
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Study start
- Aug 2009
- Primary completion
- Dec 2012 (estimated)
- First posted
- 8 Jun 2010 (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.
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lamivudine | Active comparator | Drug: lamivudine adefovir entecavir HBIG |
| lamivudine and adefovir | Active comparator | Drug: lamivudine adefovir entecavir HBIG |
| entecavir | Active comparator | Drug: lamivudine adefovir entecavir HBIG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients into the transplant waiting list with HBV-related liver disease.
- HBsAg-positive.
- serum HBV-DNA negative.
- no HCV, HDV and HIV co-infection.
- without renal dysfunction.
Key exclusion criteria (7 listed)
- patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
- HBsAg-negative.
- serum HBV-DNA positive.
- HCV, HDV and HIV co-infection.
- patients with severe renal dysfunction or failure.
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 |
|---|---|---|
| lamivudine adefovir entecavir HBIGlamivudine 100mg orally daily adefovir 10mg orally daily entecavir 0.5mg orally daily HBIG 2000 unit intravenously during the anhepatic phase,and followed 800 unit intramuscularly daily until day 14,then 400 unit intramuscularly twice weekly | Drug | entecavir, lamivudine, lamivudine and adefovir |
Primary outcome
serological markers of HBV
Time frame: every three month after liver transplantation
Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
- Background: PubMed 19373086Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32.
- Background: PubMed 18825721Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614.
- Background: PubMed 17890261Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. doi: 10.1093/ndt/gfm655.
- Background: PubMed 19852566Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599.
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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.
Zhi-Hai Peng, MD PHD study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lamivudine adefovir entecavir HBIG in people with Liver Transplantation and Hepatitis B, run by Shanghai Jiao Tong University School of Medicine 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 7 inclusion and 7 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 Jun 2010. 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 Zhi-Hai Peng, MD PHD (0086-021-63240090 ext. 3132, pengpzh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serological markers of HBV (time frame: every three month after liver transplantation). 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 NCT01139203, which also lists 4 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 28 Jun 2010.