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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131065
• Other study ID #: IG0907
• Status: Completed
• Phase: Phase 3
• First received: May 25, 2010
• Last updated: February 23, 2016
• Start date: July 2010
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Grifols Biologicals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Transplantation
• Recurrence

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	A.O.U. Policlinico Università di Modena e Reggio Emilia	Modena
Italy	Az. Ospedaliera Universitaria di Padova	Padova
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Az. Ospedaliera S.Giovanni Battista di Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV Recurrence	HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity	First six and twelve months after liver transplantation	No
Primary	HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)		Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12	No
Secondary	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.	During and after each product administration (during the 12 month treatment period)	Yes