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

NCT01131065 | Completed Phase 3 Results

• 1 other identifier: IG0907
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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

Keywords

Hepatitis B; HBV; Orthotopic liver transplantation; Liver transplantation; Recurrence; Reinfection; Protective titers; HBsAb; Hepatitis B virus immune globulin; Niuliva

Outcome Measures

Primary Outcomes (2)

• HBV Recurrence

  HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity

  First six and twelve months after liver transplantation

• 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

Secondary Outcomes (1)

• Safety and Tolerance

  During and after each product administration (during the 12 month treatment period)

Study Arms (1)

Hepatitis B immune globulin

EXPERIMENTAL

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

Drug: Hepatitis B immune globulin

Interventions

Hepatitis B immune globulin 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.

Also known as: Niuliva

Hepatitis B immune globulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (4)

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

Modena, Modena, 41100, Italy

Location

Az. Ospedaliera Universitaria di Padova

Padua, Padova, 35128, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, 56124, Italy

Location

Az. Ospedaliera S.Giovanni Battista di Torino

Torino, Torino, 10126, Italy

Location

MeSH Terms

Conditions

Hepatitis B; Recurrence; Reinfection

Interventions

hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Woodward, BSc, M.Sc
• Organization: Instituto Grifols, S.A.

michael.woodward@grifols.com

+34 935712200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 25, 2010
• First Posted: May 26, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 25, 2016
• Results First Posted: February 1, 2016

Record last verified: 2016-02

Locations

IT (4)