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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatitis B immune globulin | Experimental | Treatment group (newly liver transplanted subjects due to HBV induced liver disease) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerance | Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs. | During and after each product administration (during the 12 month treatment period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. Policlinico Università di Modena e Reggio Emilia | Modena | Modena | 41100 | Italy | ||
| Az. Ospedaliera Universitaria di Padova |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Padova |
| Padova |
| 35128 |
| Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Pisa | 56124 | Italy |
| Az. Ospedaliera S.Giovanni Battista di Torino | Torino | Torino | 10126 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 18 to 70 years of age (inclusive) | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Alcohol consumption - abstemious | Number | participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilogram |
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| Hepatitis history | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HBV Recurrence | HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity | Posted | Number | participants | First six and twelve months after liver transplantation |
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| Primary | HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration) | Posted | Mean | Standard Deviation | IU/L | Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12 |
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| Secondary | Safety and Tolerance | Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs. | Posted | Number | participants | During and after each product administration (during the 12 month treatment period) |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Biliary fistula | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
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| Liver transplant rejection | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
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| Liver function tests abnormal | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Hemorrhagic anemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Localized intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Bile duct stenosis | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
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| Biliary fistula | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
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| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
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| Biliary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Kell blood group positive | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Pharyngeal culture positive | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Aphonia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypokinesis | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Sleep disorders | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Woodward, BSc, M.Sc | Instituto Grifols, S.A. | +34 935712200 | michael.woodward@grifols.com |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D012008 | Recurrence |
| D000084063 | Reinfection |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C045213 | hepatitis B hyperimmune globulin |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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