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Completed

NCT Number: NCT01131065

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Niuliva

Primary outcomes

  1. HBV Recurrence

    Time frame: First six and twelve months after liver transplantation

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

  2. HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)

    Time frame: Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12

Secondary outcomes

  1. Safety and Tolerance

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

    Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.

Sponsors and collaborators

Lead sponsor

Instituto Grifols, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 26, 2010
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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