Hepatitis BPhase 3NCT01131065

Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients

A Phase 3 study testing Hepatitis B immune globulin in people with Hepatitis B and Liver Transplantation, run by Instituto Grifols, S.A. at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver transplantation due to HBV-induced liver disease by reaching and maintaining certain hepatitis B… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis B, Liver Transplantation
What is being tested?: Hepatitis B immune globulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 4 sitesItaly
Study dates: Jul 2010to Jun 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
Patients from 18 to 70 years of age (both included).
Serum HBV DNA-negative determined by DNA PCR-amplification assay just prior to anhepatic phase visit.
Serum HBeAg negative just prior to anhepatic phase visit.
Patients who are to undergo liver transplantation due to liver disease associated to HBV.
The patient agrees to participate and comply with all the aspects of the protocol, including blood sampling, for the total duration of the study.
Signed informed consent.

Who cannot join

Patients who have already experienced a liver transplantation even for reasons not related to HBV infection.
Patients with unknown serum HBV replication status (data on HBeAg and HBV DNA).
Patients with known allergies to any component of Niuliva®.
History of serious adverse events (SAEs) or frequent adverse events (AEs) related to the administration of human blood-derived products.
Patient with unknown viral status for HCV, HAV, HIV type 1 and type 2
Patients with selective IgA deficiency.

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Any haemostatic abnormality contraindicating i.v. injection according to the investigator's judgment.
Patient suffers from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of the study results.
Known abuse of alcohol, drugs or other chemical substances; or has done so in the past 6 months.
Breast-feeding women or pregnant women at the time of inclusion or who are expecting to be pregnant within the next 7 months after inclusion.
Subject has participated in any other investigational study within the last 3 months.
Existing possibility that the patient may be treated with other products containing specific anti-hepatitis B immunoglobins (other than Niuliva®) in a period of 13 months.
Subject is incapable of giving consent personally.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

A.O.U. Policlinico Università di Modena e Reggio Emilia
Modena, Modena, 41100
Az. Ospedaliera Universitaria di Padova
Padova, Padova, 35128
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56124
Az. Ospedaliera S.Giovanni Battista di Torino
Torino, Torino, 10126

Other trials in Italy

About this study

Official title: Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients.

Conditions: Hepatitis B, Liver Transplantation
Being tested: Hepatitis B immune globulin
Keywords: Hepatitis B, HBV, Orthotopic liver transplantation, Liver transplantation, Recurrence, Reinfection, Protective titers, HBsAb, Hepatitis B virus immune globulin, Niuliva
Medical subject headings: Hepatitis B, Recurrence, Reinfection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hepatitis B immune globulinDrug
Also called Niuliva
Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively.

Study groups in NCT01131065
Study group	Role	What they receive
Hepatitis B immune globulin	Experimental	Treatment group (newly liver transplanted subjects due to HBV induced liver disease) Receives: Drug: Hepatitis B immune globulin

What is being measured

The primary outcome is the main question the study is designed to answer.

HBV Recurrence
HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
Measured: First six and twelve months after liver transplantation
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Measured: Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12

Secondary outcomes (1)

Safety and Tolerance
Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.
Measured: During and after each product administration (during the 12 month treatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jun 2014

First posted26 May 2010 (estimated)
Study startJul 2010
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01131065
Sponsor's protocol ID: IG0907
Status last verified: Feb 2016
First submitted: 25 May 2010
Last updated: 25 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients.
ClinicalTrials.gov ID: NCT01131065
Acronym / sponsor ID: IG0907
Conditions: Hepatitis B, Liver Transplantation
Keywords: Hepatitis B, HBV, Orthotopic liver transplantation, Liver transplantation, Recurrence, Reinfection, Protective titers, HBsAb
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Instituto Grifols, S.A.Industry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 26 May 2010 (estimated)
Results: Posted 1 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hepatitis B immune globulin	Experimental	Drug: Hepatitis B immune globulinTreatment group (newly liver transplanted subjects due to HBV induced liver disease)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female.
Patients from 18 to 70 years of age (both included).
Serum HBV DNA-negative determined by DNA PCR-amplification assay just prior to anhepatic phase visit.
Serum HBeAg negative just prior to anhepatic phase visit.
Patients who are to undergo liver transplantation due to liver disease associated to HBV.

Key exclusion criteria (13 listed)

Patients who have already experienced a liver transplantation even for reasons not related to HBV infection.
Patients with unknown serum HBV replication status (data on HBeAg and HBV DNA).
Patients with known allergies to any component of Niuliva®.
History of serious adverse events (SAEs) or frequent adverse events (AEs) related to the administration of human blood-derived products.
Patient with unknown viral status for HCV, HAV, HIV type 1 and type 2

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
Hepatitis B immune globulinAlso: NiulivaDaily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively.	Drug	Hepatitis B immune globulin

Primary outcome

HBV Recurrence
Time frame: First six and twelve months after liver transplantation
HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Time frame: Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12

1 secondary outcome

Safety and Tolerance
Time frame: During and after each product administration (during the 12 month treatment period)

Results and safety

Results posted to the registry on 1 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hepatitis B Immune Globulin	15	15

Primary outcome: HBV Recurrence

Time frame: First six and twelve months after liver transplantation. Number. Unit: participants

Measure	Hepatitis B Immune Globulin n = 15
Six Months	0
Twelve Months	0

Primary outcome: HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)

Time frame: Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12. Mean (Standard Deviation). Unit: IU/L

Measure	Hepatitis B Immune Globulin n = 15
Day 3	764.7 (375.91)
Day 4	910.7 (282.39)
Day 5	969.6 (96.13)
Day 6	1000.0 (0.00)
Day 7	1000.0 (0.00)
Week 2	1073.6 (244.21)
Week 3	945.2 (250.38)
Week 4	1029.2 (175.21)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected up to 12 month following orthotopic liver transplant.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hepatitis B Immune Globulin	3 of 15 (20%)	14 of 15 (93.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Hepatitis B immune globulin in people with Hepatitis B and Liver Transplantation, run by Instituto Grifols, S.A. at 4 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 7 inclusion and 13 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 25 Feb 2016. 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 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 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?

Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

HBV Recurrence (time frame: First six and twelve months after liver transplantation). The study lists 2 primary outcomes in all. 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 NCT01131065.

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 25 Feb 2016.