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

NCT ID: NCT01131065

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-06-30

Brief 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 antibody (HBsAg) levels considered as protective during the first six and twelve months post-transplantation.

Conditions

Hepatitis B; Liver Transplantation

Study Design

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

Study Groups

Hepatitis B immune globulin

Treatment group (newly liver transplanted subjects due to HBV induced liver disease)

Group Type: EXPERIMENTAL

Hepatitis B immune globulin

Intervention Type: DRUG

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.

Interventions

Hepatitis B immune globulin

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.

Intervention Type: DRUG

Other Intervention Names

Niuliva

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

A.O.U. Policlinico Università di Modena e Reggio Emilia

Modena, Modena, Italy

Az. Ospedaliera Universitaria di Padova

Padua, Padova, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, Italy

Az. Ospedaliera S.Giovanni Battista di Torino

Torino, Torino, Italy

Countries

Italy

Other Identifiers

IG0907

Identifier Type: -

Identifier Source: org_study_id