Hepatitis B, ChronicPhase 2NCT00895713
Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation
A Phase 2 study testing intramuscular hepatitis B virus immune globulin in people with Hepatitis B, Chronic, run by Instituto Grifols, S.A. at 2 sites in Italy.
Trial summary
The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- intramuscular hepatitis B virus immune globulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2004to Jul 2005
- Phase
- Phase 2
- 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
Who may be able to join
- Male or female.
- Age > 18 years and < 70 years.
- OLT recipient for HBV infection-related disease for > 18 months before inclusion in the clinical trial.
- Serum HBsAg-positive within 3 months before transplantation.
- Serum HBsAg-negative just before inclusion in the clinical trial.
- Serum HbeAg-negative just before inclusion in the clinical trial.
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- Serum HBV DNA-negative by DNA PCR-amplification assay (lower detection limit 102 genomes/ml) just before inclusion in the clinical trial.
- Continuous and interrupted prophylaxis with HBIG after an-hepatic phase as part of the subject clinical care.
- Trough serum HBsAg Ab (HBsAg IgG) titer (immediately pre-dose) > 150 I.U./l in at least 2 consecutive determinations within last 3 months before inclusion in the clinical trail.
- Signed informed consent.
Who cannot join
- Serum HBsAg-positive just before inclusion in the clinical trial.
- Serum HBeAg-positive within 3 months before transplantation.
- Serum HBV DNA-positive by standard DNA hybridisation assay (lower detection limit 105 genomes/ml), or by any less sensitivity technique, within 3 months before transplantation.
- Unknown serum HBV replication status (no data about HbeAg and HBV DNA) within 3 months before transplantation.
- Previous recurrence of HBV in the transplanted liver defined by serum HBV DNA- positive by sensitive hybridisation (lower detection limit 105 genomes/ml) assay or any less sensitive technique, and/or serum HBeAg-positive, and/or serum HBsAg-positive.
- Re-transplanted liver even for reasons not related to HBV infection.
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- Evidence of hepatocellular carcinoma in the transplanted liver, or metastatic disease, at time of inclusion in the clinical trial.
- Evidence of graft rejection at time of inclusion in the clinical trial.
- Life-expectancy less than 1 year.
- VHC infection.
- HIV type 1 or type 2 infection.
- Acute HAV infection.
- Previous treatment with i.m. HBIG Grifols within 3 months before inclusion in the clinical trial.
- Intolerance or allergy to any i.m. HBIG Grifols containing substance (glycine, sodium chloride, sterile water for injection, homologous human immune globulin).
- History of SAEs related to the administration of human blood-derived products.
- History of frequent AEs, even non-serious, related to the administration of human blood-derived products.
- Selective IgA deficiency with Abs against IgA.
- Platelet count < 50 x 109/L.
- Prothrombin time (PT) < 60%.
- Activated partial thromboplastin time (APTT) ratio > 1.5.
- Any haemostatic abnormality contraindicating i.m. injection according to investigator's judgement.
- Haemoglobin < 11 g/dl.
- Alcohol or drug abuse at the moment or within 1 year before inclusion in the clinical trial.
- Pregnant woman or woman who is expecting to be pregnant within 1 year after inclusion in the clinical trial.
- Breast-feeding woman.
- Any severe acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, makes the subject inappropriate for entry in this clinical trial.
- Impossibility to donate a serum sample before the first investigational product administration.
- Planned treatment with Ig other than i.m. HBIG Grifols within the clinical trial period.
- Planned modification, during the clinical trial period, of the prophylactic regimen with nucleoside analogues followed by the subjects, if any, within last 3 months before inclusion in the clinical trial.
- The subject has been previously admitted to this clinical trial.
- Participation in other clinical trial within 3 months before study inclusion.
- Subject's incapacity of giving consent personally.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Cisanello Hospital. (University of Pisa).
Pisa
Ospedaliera Molinette
Torino
About this study
Official title: Efficacy and Safety of Intramuscular Hepatitis B Virus Immune Globulin Grifols for the Prevention of Hepatitis B Virus Recurrence After Orthotopic Liver Transplantation.
The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.
- Conditions
- Hepatitis B, Chronic
- Being tested
- intramuscular hepatitis B virus immune globulin
- Keywords
- Hepatitis B, HBV, Anti-hepatitis B antibodies, Immunoglobulins, liver transplantation, Protective levels, Recurrence, Intramuscular
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramuscular hepatitis B virus immune globulinDrug
Also called Igantibe
Biweekly intramuscular doses of 2000 IU administered during 6 consecutive months
| Study group | Role | What they receive |
|---|---|---|
| im HBIG Grifols | Experimental | Not described Receives: Drug: intramuscular hepatitis B virus immune globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean trough serum HBsAg Ab titer
Measured: Months 4-6
Secondary outcomes (5)
HBV recurrence percentage in long-term OLT recipients during i.m. HBIG Grifols treatment period
Measured: Week 2 - 7 months
Mean trough HBsAg Ab titer
Measured: 4 months
Individualised trough HBsAg Ab titer
Measured: Week 2 - 7 months
Number of subjects with serum HBV DNA-positive samples by DNA PCR-amplification assay
Measured: Week 2 - 7 months
Safety and tolerability
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startNov 2004
- Primary completionJun 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Franco Filipponi, Prof. MD, Principal investigator, Liver Transplantation Co-ordinating Section. Cisanello Hospital. (University of Pisa).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895713
- Sponsor's protocol ID
- IG302
- Status last verified
- May 2009
- First submitted
- 7 May 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intramuscular Hepatitis B Virus Immune Globulin Grifols for the Prevention of Hepatitis B Virus Recurrence After Orthotopic Liver Transplantation.
- ClinicalTrials.gov ID
- NCT00895713
- Acronym / sponsor ID
- IG302
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, HBV, Anti-hepatitis B antibodies, Immunoglobulins, liver transplantation, Protective levels, Recurrence, Intramuscular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 8 May 2009 (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 determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| im HBIG Grifols | Experimental | Drug: intramuscular hepatitis B virus immune globulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female.
- Age > 18 years and < 70 years.
- OLT recipient for HBV infection-related disease for > 18 months before inclusion in the clinical trial.
- Serum HBsAg-positive within 3 months before transplantation.
- Serum HBsAg-negative just before inclusion in the clinical trial.
Key exclusion criteria (32 listed)
- Serum HBsAg-positive just before inclusion in the clinical trial.
- Serum HBeAg-positive within 3 months before transplantation.
- Serum HBV DNA-positive by standard DNA hybridisation assay (lower detection limit 105 genomes/ml), or by any less sensitivity technique, within 3 months before transplantation.
- Unknown serum HBV replication status (no data about HbeAg and HBV DNA) within 3 months before transplantation.
- Previous recurrence of HBV in the transplanted liver defined by serum HBV DNA- positive by sensitive hybridisation (lower detection limit 105 genomes/ml) assay or any less sensitive technique, and/or serum HBeAg-positive, and/or serum HBsAg-positive.
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 |
|---|---|---|
| intramuscular hepatitis B virus immune globulinAlso: IgantibeBiweekly intramuscular doses of 2000 IU administered during 6 consecutive months | Drug | im HBIG Grifols |
Primary outcome
Mean trough serum HBsAg Ab titer
Time frame: Months 4-6
5 secondary outcomes
HBV recurrence percentage in long-term OLT recipients during i.m. HBIG Grifols treatment period
Time frame: Week 2 - 7 months
Mean trough HBsAg Ab titer
Time frame: 4 months
Individualised trough HBsAg Ab titer
Time frame: Week 2 - 7 months
Number of subjects with serum HBV DNA-positive samples by DNA PCR-amplification assay
Time frame: Week 2 - 7 months
Safety and tolerability
Time frame: 7 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 8 May 2009.
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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.
Franco Filipponi, Prof. MD principal investigator
Liver Transplantation Co-ordinating Section. Cisanello Hospital. (University of Pisa).
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intramuscular hepatitis B virus immune globulin in people with Hepatitis B, Chronic, run by Instituto Grifols, S.A. at 2 sites in Italy.
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 10 inclusion and 32 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 8 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean trough serum HBsAg Ab titer (time frame: Months 4-6). 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 8 May 2009.