A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant

NCT ID: NCT01856413

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-09-30

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).

Conditions

Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Zutectra

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

Group Type: EXPERIMENTAL

Zutectra

Intervention Type: DRUG

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

Interventions

Zutectra

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

Intervention Type: DRUG

Other Intervention Names

Human hepatitis B Immunoglobulin; HBIg

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AMS Advanced Medical Services GmbH

INDUSTRY

Sponsor Role: collaborator

Biotest

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Samuel, Professeur

Role: PRINCIPAL_INVESTIGATOR

Hospital Paul Brousse, Centre Hepato-Biliaire

Locations

Hopital de la Croix Rousse

Lyon, , France

Hôpital Paul Brousse

Villejuif, , France

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, , Italy

S. Orsola Hospital

Bologna, , Italy

Azienda ospedaliera "G. Brutzu" di Cagliari

Cagliari, , Italy

Azienda Ospedaliera Ospedale Niguarda Ca Granda-Chirurgia

Milan, , Italy

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

Modena, , Italy

Azienda Ospedialera Universitaria di Padova

Padua, , Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Fondazione Policlinico Tor-Vergata U.O.C.

Roma, , Italy

Molinette Hospital

Torino, , Italy

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

Birmingham, , United Kingdom

King's College Hospital

London, , United Kingdom

Countries

France; Italy; Spain; United Kingdom

Other Identifiers

2012-002516-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BT 987

Identifier Type: -

Identifier Source: org_study_id