Brief Summary

Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral antiviral medication. In the first 6 months after liver transplantation, patients receive treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody concentrations above 100 IU/L, the level considered safe for preventing hepatitis B reinfection. Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure'. The purpose of this study is to show that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can prevent hepatitis B reinfection. Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of patients and is more convenient for patients compared to intravenous treatment that must take place in the hospital setting. Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy and Spain. Patients who are eligible for the study will receive treatment with Zutectra for 24 weeks. During the study, the safety and effectiveness of Zutectra will be assessed by checking for symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs antibodies and hepatitis B surface antigen (HBsAg).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Dec 2012

Geographic Reach

4 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

December 1, 2012

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

May 15, 2013

Last Update Submit

March 24, 2015

Conditions

Hepatitis B

Keywords

PreventionHepatitis B virus re-infectionHBV-DNA negativeLiver transplantation

Outcome Measures

Primary Outcomes (1)

Trough levels of serum anti-HBs antibody concentrations
24 weeks

Secondary Outcomes (1)

Hepatitis B related re-infections
24 weeks

Other Outcomes (1)

Adverse Events
24 weeks

Study Arms (1)

Zutectra

EXPERIMENTAL

Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.

Drug: Zutectra

Interventions

ZutectraDRUG

Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.

Also known as: Human hepatitis B Immunoglobulin, HBIg

Zutectra

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT
Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent
Male and female patients (age 18-75 years)
Patients with the diagnosis of liver failure with hepatitis B infection
Patients undergoing liver transplantation or re-transplantation
HBsAg negative on day 7 or on day 14 after OLT
HBV-DNA undetectable at OLT
Serum HBs antibody concentration on day 7 or on day 14 after OLT ≥ 400 IU/l
Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study
Willingness to fill out patient diary

You may not qualify if:

Re-transplantation due to viral recurrence
Positive HIV or HCV test at time of transplantation
HBV-DNA positive at OLT
Patients having received organs from HBsAg positive donors
Pregnancy or unreliable contraceptive measures or lactation period (females only)
Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
Known intolerance to proteins of human origin
Participation in another interventional clinical trial within 90 days before entering the study or during the study and/or previous participation in this study (except screening failures)
Suspicion of drug and/or alcohol abuse
Inability or lacking motivation to participate in the study
Employee or direct relative of an employee of the CRO, the study site, or Biotest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biotestlead
AMS Advanced Medical Services GmbHcollaborator

Study Sites (16)

Hopital de la Croix Rousse

Lyon, 69004, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, 70124, Italy

Location

S. Orsola Hospital

Bologna, 40138, Italy

Location

Azienda ospedaliera "G. Brutzu" di Cagliari

Cagliari, CA 09135, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Ca Granda-Chirurgia

Milan, 20162, Italy

Location

Liver and Multivisceral Transplant Center, University of Modena and Reggio Emilia

Modena, 41100, Italy

Location

Azienda Ospedialera Universitaria di Padova

Padua, 35122, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, 54124, Italy

Location

Fondazione Policlinico Tor-Vergata U.O.C.

Roma, 00133, Italy

Location

Molinette Hospital

Torino, 10126, Italy

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

BT088 immunoglobulin, humanhepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

Didier Samuel, Professeur
Hospital Paul Brousse, Centre Hepato-Biliaire
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 17, 2013

Study Start

December 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

FR(2)ES(3)GB(2)IT(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (1)

Zutectra

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations