Hepatitis B immunoglobulin (HBIg) withdrawal from combination lamivudine (LAM)/HBIg prophylaxis in liver transplant recipients
ISRCTN | ISRCTN52111708 |
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DOI | https://doi.org/10.1186/ISRCTN52111708 |
Secondary identifying numbers | RG_05-002 |
- Submission date
- 19/09/2005
- Registration date
- 12/10/2005
- Last edited
- 11/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Mutimer
Scientific
Scientific
Liver Unit
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Hepatitis B immunoglobulin (HBIg) withdrawal from combination lamivudine (LAM)/HBIg prophylaxis in liver transplant recipients |
Study acronym | HBIg/ADV |
Study objectives | The aim of this study is to evaluate the safety of HBIg withdrawal from patients who are receiving combination lamivudine/HBIg following liver transplantation. The proposed study design will examine the following hypotheses: 1. It is safe to withdraw HBIg from the existing prophylaxis regime for recipients who had a low pre-treatment serum HBV titre 2. Combination lamivudine and adefovir dipivoxil will provide a safe alternative to lamivudine and HBIg prophylaxis for recipients who had a high pre-treatment serum HBV titre |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Hepatitis B virus infected liver transplant recipients |
Intervention | Patients will be stratified into two groups according to the pre-lamivudine treatment, pre-transplantation serum HBV DNA titre (baseline viral load): Stratum A: in high-risk patients: HBV DNA more than or equal to 1.0 x 10^6 genomic copies/ml or patients who had detectable serum HBV DNA measured with hybridisation assays. (Patients who have not serum HBV DNA measured before commencement of lamivudine treatment may be included in the study, but must enter stratum A). Patients will be randomised (1:1) into two groups: Arm 1: LAM 100 mg QD + HBIg (according to each participating units existing protocol) for 2 years, with ADV being used as a rescue therapy Arm 2: LAM 100 mg QD + ADV 10 mg QD for 2 years Stratum B: in low-risk patients (HBV DNA less than 1.0 x 10^6 genomic copies/ml) Arm 3: LAM 100 mg QD only for 2 years (ADV will function as a rescue medication after withdrawal of HBIg) |
Intervention type | Other |
Primary outcome measure | The incidence of emergence of detectable serum HBV DNA during prophylaxis (more than or equal to 200 copies/ml HBV DNA). |
Secondary outcome measures | The response of serum HBV DNA and outcome of HBV infection for those patients who require adefovir dipivoxil rescue |
Overall study start date | 01/10/2005 |
Completion date | 01/10/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 120 |
Key inclusion criteria | 1. Male or female patients 18 to 75 years of age 2. Patients with serum HBsAg negativity and HBV DNA negativity (<200 copies/mL as per Roche COBAS AMPLICOR HBV MONITOR) 3. Patients have received a liver transplantation and have been successfully treated with lamivudine and HBIg for at least 12 months 4. Females of childbearing potential must have a negative urine pregnancy test at screening. Pre-menopausal females who are using effective methods of contraception and who agree to continue to do so for the duration of the study medication dosing and for 30 days after the last dose of study medication will be able to participate. Post-menopausal females will be eligible for enrollment 5. Confirmation that sexually active males must be practicing acceptable methods of contraception (vasectomy, condom, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period 6. Able to give written informed consent and comply with the requirements of the study |
Key exclusion criteria | 1. Lactating females or females with a positive pregnancy test 2. History of hypersensitivity to HBIg, lamivudine or adefovir dipivoxil. HCV, hepatitis delta virus (HDV), and/or human immunodeficiency virus (HIV) seropositive 3. Evidence of active liver disease due to other causes (e.g. Wilsons disease, hemochromatosis, autoimmune hepatitis, hepatitis C or hepatitis D co-infection, known HIV positivity, alpha-1 antitrypsin deficiency, alcoholic liver disease, obesity-induced liver disease, drug-related liver diseases) 4. Previous participation in an investigational trial involving administration of any investigational compound within 3 months prior to the study screening 5. Clinically relevant alcohol or drug use or history of alcohol or drug use considered by the investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events 6. Therapy with nephrotoxic drugs (e.g. aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cis-platin, pentamidine) or competitors of renal excretion (e.g. probenecid) within 2 months prior to study screening or the expectation that subject will receive these during the course of the study, unless clinically mandated 7. The use of antiviral therapy with agents demonstrating potential anti-HBV activity within the previous 3 months (e.g. adefovir dipivoxil, famciclovir, lobucavir, emtricitabine, DAPD, LFMAU, entecavir, ganciclovir, tenofovir or others), other than lamivudine and HBIg |
Date of first enrolment | 01/10/2005 |
Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liver Unit
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Website | http://www.bham.ac.uk |
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https://ror.org/03angcq70 |
Funders
Funder type
Industry
Educational Grant from Gilead Sciences Inc
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
11/04/2017: No publications found in PubMed, verifying study status with principal investigator