Trial record 1 of 1 for:    NCT01131065
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Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients

This study is currently recruiting participants.
Verified March 2013 by Grifols Biologicals Inc.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT01131065
First received: May 25, 2010
Last updated: March 18, 2013
Last verified: March 2013

May 25, 2010
March 18, 2013
September 2010
December 2013   (final data collection date for primary outcome measure)
  • HBV recurrence [ Time Frame: First six months after liver transplantation ] [ Designated as safety issue: No ]
    HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
  • HBsAb pre-infusion levels (through levels before each Niuliva administration) [ Time Frame: First six months after liver transplantation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01131065 on ClinicalTrials.gov Archive Site
Safety and tolerance [ Time Frame: During and after each product administration (during the 6 month treatment period) ] [ Designated as safety issue: Yes ]
Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
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 and safety 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 months post-transplantation.

In addition, the safety and tolerability of the administration of Niuliva will also be assessed.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hepatitis B
  • Liver Transplantation
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, and 6, respectively.
Other Name: Niuliva
Experimental: Hepatitis B immune globulin
Treatment group
Intervention: Drug: Hepatitis B immune globulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2013
December 2013   (final data collection date for primary outcome measure)

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
  • Evidence of hepatocellular carcinoma in the transplanted liver, or metastatic disease, at time of inclusion in the clinical trial.
  • 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 7 months.
  • Subject is incapable of giving consent personally.
Both
18 Years to 70 Years
No
Contact: Antonio Páez, MD +34 935710700 antonio.paez@grifols.com
Contact: Michael K Woodward, BSc +34 935710700 mwoodward@grifols.com
Italy
 
NCT01131065
IG 0907
No
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
Instituto Grifols, S.A.
Not Provided
Principal Investigator: Paolo de Simone, MD Azienda Ospedaliero, Universitaria Pisana
Grifols Biologicals Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP