Hepatitis BPhase 3NCT01884415
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
A Phase 3 study testing HBV vaccine in people with Hepatitis B and Cirrhosis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Cirrhosis, Awaiting Organ Transplant
- What is being tested?
- HBV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2012to Dec 2017
- Phase
- Phase 3
- 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
- Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).
- Patients under treatment with HBVAXPRO® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
- Patients over 18 years old.
- Negative pregnancy test.
- Patients who have given their consent to participate in the study.
Who cannot join
- Absolute contraindication to HBV vaccine.
- Medical history of allergy to any component of the vaccine.
- Chronic renal failure on hemodialysis.
- Presence of antibodies against Human Immunodeficiency Virus.
- Patients with seroconversion (anti-HBs > 10 IU /ml) after the first three doses of vaccine.
- Lack of consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Phase III, Randomized, Clinical Trial to Evaluate the Efficacy of Two Different Hepatitis B Virus (HBV) Vaccination Schemes in Patients With Hepatic Cirrhosis Candidates to Liver Transplantation
The objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg.
- Conditions
- Hepatitis B, Cirrhosis, Awaiting Organ Transplant
- Being tested
- HBV vaccine
- Medical subject headings
- Hepatitis B, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV vaccineBiological
Also called HBVAXPRO 40µg HBV vaccine
Patients receive a second cycle of vaccination
HBV vaccineBiological
Also called HBVAXPRO 40µg HBV vaccine
Patients receive vaccination according to the guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Second HBV vaccination cycle | Experimental | Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg. Receives: Biological: HBV vaccine |
| Single dose of HBV vaccine | Active comparator | Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination Receives: Biological: HBV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-vaccination serological response
To compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients potential candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg at 0, 1 and 2 months.
Measured: At 35 ± 5 days after administration
Secondary outcomes (5)
Association of serological response to HBV vaccination to etiology and severity of cirrhosis
Etiology and severity of cirrhosis
Measured: After 6 months
Association of serological response to HBV vaccination to diabetes presence
Diabetes
Measured: After 6 months
Association of serological response to HBV vaccination to body mass index
Body mass index
Measured: At baseline
Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence
Presence of anti-Hepatitis B core antigen positive
Measured: At baseline
Association of serological response to HBV vaccination to obesity
Obesity
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study start7 Sep 2012
- Primary completionDec 2017
- Study completionDec 2017
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Manual Pascasio Acevedo, MD, PhD, Study director, Virgen del Rocío Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884415
- Sponsor's protocol ID
- HEPATOTRAS
- Status last verified
- May 2018
- First submitted
- 18 Jun 2013
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Giraldez-Gallego A, Rodriguez-Seguel EDP, Valencia-Martin R, Morillo-Garcia A, Salamanca-Rivera C, Ruiz-Perez R, Cuaresma-Duque M, Rosso-Fernandez C, Ferrer-Rios MT, Sousa-Martin JM, Praena-Fernandez JM, Desongles-Corrales T, Rodriguez-Perez A, Camino-Duran F, Gasch-Illescas A, Ampuero-Herrojo J, Pascasio-Acevedo JM. Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial. Gut. 2023 Dec 7;73(1):166-174. doi: 10.1136/gutjnl-2022-328222.
PubMed 36963815
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase III, Randomized, Clinical Trial to Evaluate the Efficacy of Two Different Hepatitis B Virus (HBV) Vaccination Schemes in Patients With Hepatic Cirrhosis Candidates to Liver Transplantation
- ClinicalTrials.gov ID
- NCT01884415
- Acronym / sponsor ID
- HEPATOTRAS
- Conditions
- Hepatitis B, Cirrhosis, Awaiting Organ Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 7 Sep 2012 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Jun 2013 (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 objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second HBV vaccination cycle | Experimental | Biological: HBV vaccineSecond cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg. |
| Single dose of HBV vaccine | Active comparator | Biological: HBV vaccineSingle dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).
- Patients under treatment with HBVAXPRO® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
- Patients over 18 years old.
- Negative pregnancy test.
- Patients who have given their consent to participate in the study.
Key exclusion criteria (6 listed)
- Absolute contraindication to HBV vaccine.
- Medical history of allergy to any component of the vaccine.
- Chronic renal failure on hemodialysis.
- Presence of antibodies against Human Immunodeficiency Virus.
- Patients with seroconversion (anti-HBs > 10 IU /ml) after the first three doses of vaccine.
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 vaccineAlso: HBVAXPRO 40µg HBV vaccinePatients receive a second cycle of vaccination | Biological | Second HBV vaccination cycle |
| HBV vaccineAlso: HBVAXPRO 40µg HBV vaccinePatients receive vaccination according to the guidelines. | Biological | Single dose of HBV vaccine |
Primary outcome
Post-vaccination serological response
Time frame: At 35 ± 5 days after administration
To compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients potential candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg at 0, 1 and 2 months.
5 secondary outcomes
Association of serological response to HBV vaccination to etiology and severity of cirrhosis
Time frame: After 6 months
Association of serological response to HBV vaccination to diabetes presence
Time frame: After 6 months
Association of serological response to HBV vaccination to body mass index
Time frame: At baseline
Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence
Time frame: At baseline
Association of serological response to HBV vaccination to obesity
Time frame: After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 36963815Giraldez-Gallego A, Rodriguez-Seguel EDP, Valencia-Martin R, Morillo-Garcia A, Salamanca-Rivera C, Ruiz-Perez R, Cuaresma-Duque M, Rosso-Fernandez C, Ferrer-Rios MT, Sousa-Martin JM, Praena-Fernandez JM, Desongles-Corrales T, Rodriguez-Perez A, Camino-Duran F, Gasch-Illescas A, Ampuero-Herrojo J, Pascasio-Acevedo JM. Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial. Gut. 2023 Dec 7;73(1):166-174. doi: 10.1136/gutjnl-2022-328222.
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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.
Juan Manual Pascasio Acevedo, MD, PhD study director
Virgen del Rocío Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HBV vaccine in people with Hepatitis B and Cirrhosis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 6 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: finished, as of the sponsor's last update on 14 May 2018. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-vaccination serological response (time frame: At 35 ± 5 days after administration). 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 NCT01884415, 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 14 May 2018.