Trial Outcomes & Findings for Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients (NCT NCT01131065)
NCT ID: NCT01131065
Last Updated: 2016-02-25
Results Overview
HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
First six and twelve months after liver transplantation
Results posted on
2016-02-25
Participant Flow
Fifteen subjects (newly liver transplanted due to HBV induced liver disease) were screened in the study, all received the study medication, and all completed the clinical study. First subject enrolled - 26 July 2010 Last subject completed - 16 June 2014
Participant milestones
| Measure |
Hepatitis B Immune Globulin
Treatment group
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
Baseline characteristics by cohort
| Measure |
Hepatitis B Immune Globulin
n=15 Participants
Treatment group
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
|
Alcohol consumption - abstemious
|
15 participants
n=5 Participants
|
|
Height
|
170.33 centimeters
STANDARD_DEVIATION 8.08 • n=5 Participants
|
|
Weight
|
73.73 kilogram
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Hepatitis history
Has chronic HBV
|
15 participants
n=5 Participants
|
|
Hepatitis history
Has fulminant HBV
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First six and twelve months after liver transplantationHBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
Outcome measures
| Measure |
Hepatitis B Immune Globulin
n=15 Participants
Treatment group
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.
|
|---|---|
|
HBV Recurrence
Six Months
|
0 participants
|
|
HBV Recurrence
Twelve Months
|
0 participants
|
PRIMARY outcome
Timeframe: Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12Outcome measures
| Measure |
Hepatitis B Immune Globulin
n=15 Participants
Treatment group
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.
|
|---|---|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Week 4
|
1029.2 IU/L
Standard Deviation 175.21
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Day 3
|
764.7 IU/L
Standard Deviation 375.91
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Day 4
|
910.7 IU/L
Standard Deviation 282.39
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Day 5
|
969.6 IU/L
Standard Deviation 96.13
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Day 6
|
1000.0 IU/L
Standard Deviation 0.00
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Day 7
|
1000.0 IU/L
Standard Deviation 0.00
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Week 2
|
1073.6 IU/L
Standard Deviation 244.21
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Week 3
|
945.2 IU/L
Standard Deviation 250.38
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 2
|
592.5 IU/L
Standard Deviation 260.14
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 3
|
439.2 IU/L
Standard Deviation 218.22
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 4
|
398.1 IU/L
Standard Deviation 272.68
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 5
|
351.9 IU/L
Standard Deviation 179.01
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 6
|
369.0 IU/L
Standard Deviation 182.75
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 7
|
277.7 IU/L
Standard Deviation 89.14
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 8
|
304.3 IU/L
Standard Deviation 50.24
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 9
|
266.0 IU/L
Standard Deviation 34.70
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 10
|
301.0 IU/L
Standard Deviation 61.99
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 11
|
273.3 IU/L
Standard Deviation 117.93
|
|
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
Month 12
|
284.3 IU/L
Standard Deviation 137.47
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hepatitis B Immune Globulin
n=15 Participants
Treatment group
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.
|
|---|---|
|
Safety and Tolerance
|
15 participants
|
Adverse Events
Hepatitis B Immune Globulin
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hepatitis B Immune Globulin
n=15 participants at risk
Treatment group
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.
|
|---|---|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Hepatobiliary disorders
Biliary fistula
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Immune system disorders
Liver transplant rejection
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Liver function tests abnormal
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
Other adverse events
| Measure |
Hepatitis B Immune Globulin
n=15 participants at risk
Treatment group
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Blood and lymphatic system disorders
Hemorrhagic anemia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Cardiac disorders
Angina pectoris
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Gastrointestinal disorders
Localized intra-abdominal fluid collection
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Hepatobiliary disorders
Bile duct stenosis
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Hepatobiliary disorders
Biliary fistula
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Immune system disorders
Transplant rejection
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Infections and infestations
Biliary tract infection
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Infections and infestations
Herpes virus infection
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Infections and infestations
Postoperative wound infection
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Blood glucose increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Cardiac murmur
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Hepatic enzyme increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Kell blood group positive
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Pharyngeal culture positive
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Investigations
Weight decreased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Nervous system disorders
Aphonia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Nervous system disorders
Hypokinesis
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Nervous system disorders
Tremor
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Psychiatric disorders
Sleep disorders
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Renal and urinary disorders
Renal failure
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Renal and urinary disorders
Renal failure acute
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
|
Vascular disorders
Hypertension
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected up to 12 month following orthotopic liver transplant.
The duration of treatment was 6 months after which subjects were offered the option to be treated for an additional 6 months (12 months total).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsor's request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsor's request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor's Inventions.
- Publication restrictions are in place
Restriction type: OTHER