Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01131065 | Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients | PHASE3 | COMPLETED | 15 | — | — | Jul 1, 2010 | Jun 1, 2014 | Feb 25, 2016 | 4 | Italy |
HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
| Arm | Type | Description |
|---|---|---|
| Hepatitis B immune globulin | EXPERIMENTAL | Treatment group (newly liver transplanted subjects due to HBV induced liver disease) |
| Name | Type | Description |
|---|---|---|
| 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. |
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 transp...