Hepatitis B, ChronicPhase 3NCT00838071
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
A Phase 3 study testing Specific intravenous anti-hepatitis B immunoglobulin in people with Hepatitis B, Chronic, run by Instituto Grifols, S.A. at 4 sites in Spain.
Trial summary
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone 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?
- Specific intravenous anti-hepatitis B immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesSpain
- Study dates
- Oct 2003to Aug 2004
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study.
- Patients who have required treatment with HBIG, or are receiving it at present.
- Patients from 18 to 70 years of age.
- The patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form.
Who cannot join
- Presence of HBV DNA or HBeAg indicating virus replication.
- Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
- Patients with a known background of severe or frequent reactions to products derived from plasma.
- Patients presenting arterial hypertension that is not clinically controlled.
- Patients presenting a creatinine value >2 mg/dl, nephrotic syndrome or renal failure.
- Patients presenting anaemia (haemoglobin < 11 g/dl).
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- Patients being treated with interferon.
- The patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study.
- The patient is known to abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the past 12 months.
- Pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women.
- Patients participating in another clinical study, or who have received another investigational product in the last 3 months.
- Possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months.
- Suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year.
- Any patient that does not have a frozen serum sample previous to the first study medication infusion.
- Patients with selective IgA deficiency.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08035
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Virgen del Rocío
Seville, Sevilla, 41013
About this study
Official title: Evaluation of Anti-Hepatitis B Antibodies Levels in Serum After the Intravenous Administration of Specific Anti-Hepatitis B Immunoglobulin (IGIV-HB Grifols) in Patients Having Previously Undergone Liver Transplantation
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Specific intravenous anti-hepatitis B immunoglobulin
- Keywords
- Hepatitis B, HBV, Anti-hepatitis B antibodies, Immunoglobulins, liver transplantation, Protective levels, Recurrence, Intravenous
- 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.
Specific intravenous anti-hepatitis B immunoglobulinDrug
Also called Niuliva
Monthly doses of 5000 IU administered intravenously during 6 consecutive months
| Study group | Role | What they receive |
|---|---|---|
| IGIV-HB Grifols | Experimental | Not described Receives: Drug: Specific intravenous anti-hepatitis B immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months.
Measured: At months 4, 5, and 6
Secondary outcomes (5)
To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose.
Measured: At months 1, 2, 3, 4, 5, and 6
To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols
Measured: At months 1, 2, 3, 4, 5, and 6
To determine the incidence of recurrences during the treatment
Measured: At months 1, 2, 3, 4, 5, and 6
To evaluate tolerance to the administration of HB-IVIG Grifols
Measured: At months 1, 2, 3, 4, 5, and 6
To confirm the viral safety of the product supervising viral markers
Measured: At months 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startOct 2003
- Primary completionJul 2004
- Study completionAug 2004
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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antoni Mas, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838071
- Sponsor's protocol ID
- IG301
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anti-Hepatitis B Antibodies Levels in Serum After the Intravenous Administration of Specific Anti-Hepatitis B Immunoglobulin (IGIV-HB Grifols) in Patients Having Previously Undergone Liver Transplantation
- ClinicalTrials.gov ID
- NCT00838071
- Acronym / sponsor ID
- IG301
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, HBV, Anti-hepatitis B antibodies, Immunoglobulins, liver transplantation, Protective levels, Recurrence, Intravenous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 6 Feb 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 whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGIV-HB Grifols | Experimental | Drug: Specific intravenous anti-hepatitis B immunoglobulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study.
- Patients who have required treatment with HBIG, or are receiving it at present.
- Patients from 18 to 70 years of age.
- The patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form.
Key exclusion criteria (15 listed)
- Presence of HBV DNA or HBeAg indicating virus replication.
- Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
- Patients with a known background of severe or frequent reactions to products derived from plasma.
- Patients presenting arterial hypertension that is not clinically controlled.
- Patients presenting a creatinine value >2 mg/dl, nephrotic syndrome or renal 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 |
|---|---|---|
| Specific intravenous anti-hepatitis B immunoglobulinAlso: NiulivaMonthly doses of 5000 IU administered intravenously during 6 consecutive months | Drug | IGIV-HB Grifols |
Primary outcome
To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months.
Time frame: At months 4, 5, and 6
5 secondary outcomes
To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose.
Time frame: At months 1, 2, 3, 4, 5, and 6
To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols
Time frame: At months 1, 2, 3, 4, 5, and 6
To determine the incidence of recurrences during the treatment
Time frame: At months 1, 2, 3, 4, 5, and 6
To evaluate tolerance to the administration of HB-IVIG Grifols
Time frame: At months 1, 2, 3, 4, 5, and 6
To confirm the viral safety of the product supervising viral markers
Time frame: At months 1, 2, 3, 4, 5, and 6
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 6 Feb 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.
Antoni Mas, MD principal investigator
Hospital Clinic of Barcelona
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Specific intravenous anti-hepatitis B immunoglobulin in people with Hepatitis B, Chronic, run by Instituto Grifols, S.A. at 4 sites 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 4 inclusion and 15 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 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months. (time frame: At months 4, 5, and 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 6 Feb 2009.