Not provided
Not provided
Not provided
Not provided
The study was terminated due to slower than anticipated subject accrual.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether a human monoclonal antibody against Hepatitis C (MBL-HCV1) is effective in preventing detectable levels of Hepatitis C virus in patients undergoing liver transplantation due to chronic HCV infection. The study will also determine if MBL-HCV1 is effective in delaying or reducing the amount of detectable HCV in patients after transplant.
This is a Phase 2, randomized, double-blind, placebo controlled study in Hepatitis C (HCV) infected patients undergoing liver transplantation. Chronically infected patients with HCV genotype 1a scheduled to receive a liver transplant from either a deceased or living donor who satisfy all study inclusion or exclusion criteria will be approached to participate. The study will be conducted in two parts to test a human monoclonal antibody against Hepatitis C (MBL-HCV1). In Part 1, sixteen eligible patients will be randomized 1:1 to receive 50 mg/kg MBL-HCV1 or 0.9% sodium chloride placebo intravenously. Eleven doses will be given during the first 14 days post transplantation. Patients will be evaluated through day 56 for safety and clinical outcomes that include measurement of anti-HCV antibodies, anti-drug antibody and HCV viral load. On study visit day 42, a liver biopsy will be performed for evaluation of hepatitis. Physical examination, vital sign measurements, emergence of adverse events and concomitant medication usage will be assessed at scheduled visits and as needed during the 56 day study period.
The Data Safety and Monitoring Board will perform a futility analysis after the first 16 patients have been enrolled and completed study follow-up through study visit day 42 post transplant. Based on the results of the interim analysis, the dose of MBL-HCV1 for part 2 of the study will be determined. Part 2 of the study will be conducted in the same manner as Part 1.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBL-HCV1 | Experimental |
| |
| 0.9% sodium chloride | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBL-HCV1 | Biological | 50 mg/kg MBL-HCV1, intravenous |
| |
| 0.9% Sodium chloride Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Detectable Serum HCV RNA at Day 42 Post-Transplantation | Serum HCV RNA was measured by Quantitative RT-PCR | At Day 42 post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined Through Medical History, Physical Examination and Laboratory Evaluation | Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Subjects were asked at scheduled study visits through day 42 whether they experienced solicited adverse reactions (fever, chills, nausea, rash, joint pain or swelling, shortness of breath, headache, fatigue, and hives). In addition to these solicited adverse events, subjects were asked at all scheduled study visits through day 56 to report any other adverse events, regardless of whether the event was thought to be related to the study infusions. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 12.0) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah C. Molrine, MD | Massbiologics of University of Massachusetts Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06504 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23356386 | Result | Chung RT, Gordon FD, Curry MP, Schiano TD, Emre S, Corey K, Markmann JF, Hertl M, Pomposelli JJ, Pomfret EA, Florman S, Schilsky M, Broering TJ, Finberg RW, Szabo G, Zamore PD, Khettry U, Babcock GJ, Ambrosino DM, Leav B, Leney M, Smith HL, Molrine DC. Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study. Am J Transplant. 2013 Apr;13(4):1047-1054. doi: 10.1111/ajt.12083. Epub 2013 Jan 28. |
Not provided
Not provided
Reasons for exclusion after randomization included identification of a protocol-specified exclusion criterion in the recipient or the donor at the time of organ offer or failure to undergo liver transplantation.
Patients with HCV genotype 1a infection scheduled to undergo liver transplantation were recruited at 8 U.S. transplantation centers between June 2010 and April 2011. Due to slower than anticipated subject accrual, enrollment was stopped after 13 subjects were randomized; 11 underwent liver transplantation and received the study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: MBL-HCV1 | Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
0.9% sodium chloride, intravenous |
|
|
| Through Day 56 |
| Change in Serum HCV RNA Between Baseline and Day 3, 14, 28 and 42 Post-Transplantation | Serum HCV RNA was measured by quantitative RT-PCR. The change in HCV RNA from baseline was obtained by calculating the difference between the baseline pre-transplantation HCV RNA level and the HCV RNA level measured at each study visit. | Baseline and Day 3, 14, 28 and 42 Post-Transplantation |
| Histologic Evidence of Hepatitis by Histologic Activity Index (HAI) Score at Baseline and Day 42 | Liver biopsies obtained at baseline (day 0) and day 42 post-transplantation were assessed for histologic evidence of hepatitis by a pathologist blinded to treatment assignment using the Ishak modification of the Knodell histologic grading system to assign a histologic activity index (HAI) score. The HAI score consists of a sum of four components: 1) periportal or periseptal interface hepatitis; 2) confluent necrosis; 3) focal lytic necrosis, apoptosis and focal inflammation; 4) portal inflammation. The total HAI score can range from a minimum of 0 to a maximum of 18, with higher scores indicating more severe hepatic inflammation. | Baseline Day 0 and Day 42 |
| Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / International Normalized Ratio (INR) | Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the INR at each time-point. The INR is the ratio of a patient's prothrombin time to a control sample, raised to the power of the ISI value (International Sensitivity Index) for the batch of tissue factor being used for the assay. | Through Day 56 |
| Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Alanine Aminotransferase (ALT) | Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the ALT at each time-point. | Through Day 56 |
| Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Total Bilirubin | Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the total bilirubin at each time-point. | Through Day 56 |
| Time to Onset of Recurrence of Detectable HCV RNA Post-Transplantation | Serum HCV RNA was measured by Quantitative RT-PCR | Through Day 56 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Methodist Healthcare Foundation | Memphis | Tennessee | 38104 | United States |
| FG001 | Placebo Comparator: 0.9% Sodium Chloride | Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation. |
| Infused |
|
| Transplanted |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: MBL-HCV1 | Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation. |
| BG001 | Placebo Comparator: 0.9% Sodium Chloride | Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Hepatocellular carcinoma | Number | participants |
| ||||||||||||||||
| Serum HCV RNA concentration | Median | Full Range | log10 IU/mL |
|
| 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 | Proportion of Subjects With Detectable Serum HCV RNA at Day 42 Post-Transplantation | Serum HCV RNA was measured by Quantitative RT-PCR | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Number | percentage of participants | At Day 42 post-transplantation |
|
|
| |||||||||||||||||||||||||||||
| Secondary | The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined Through Medical History, Physical Examination and Laboratory Evaluation | Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Subjects were asked at scheduled study visits through day 42 whether they experienced solicited adverse reactions (fever, chills, nausea, rash, joint pain or swelling, shortness of breath, headache, fatigue, and hives). In addition to these solicited adverse events, subjects were asked at all scheduled study visits through day 56 to report any other adverse events, regardless of whether the event was thought to be related to the study infusions. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 12.0) | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Number | events | Through Day 56 |
| |||||||||||||||||||||||||||||||
| Secondary | Change in Serum HCV RNA Between Baseline and Day 3, 14, 28 and 42 Post-Transplantation | Serum HCV RNA was measured by quantitative RT-PCR. The change in HCV RNA from baseline was obtained by calculating the difference between the baseline pre-transplantation HCV RNA level and the HCV RNA level measured at each study visit. | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Median | Full Range | log10 IU/mL | Baseline and Day 3, 14, 28 and 42 Post-Transplantation |
| ||||||||||||||||||||||||||||||
| Secondary | Histologic Evidence of Hepatitis by Histologic Activity Index (HAI) Score at Baseline and Day 42 | Liver biopsies obtained at baseline (day 0) and day 42 post-transplantation were assessed for histologic evidence of hepatitis by a pathologist blinded to treatment assignment using the Ishak modification of the Knodell histologic grading system to assign a histologic activity index (HAI) score. The HAI score consists of a sum of four components: 1) periportal or periseptal interface hepatitis; 2) confluent necrosis; 3) focal lytic necrosis, apoptosis and focal inflammation; 4) portal inflammation. The total HAI score can range from a minimum of 0 to a maximum of 18, with higher scores indicating more severe hepatic inflammation. | The 11 subjects who were randomized, initiated study infusions, and underwent transplantation were included in the analysis population. On day 0, all subjects had pre-transplant biopsy specimens available for analysis. On day 42, 4 subjects in the MBL-HCV1 group and 5 subjects in the placebo group had biopsy specimens available for analysis. | Posted | Median | Full Range | Histologic activity index (HAI) score | Baseline Day 0 and Day 42 |
| ||||||||||||||||||||||||||||||
| Secondary | Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / International Normalized Ratio (INR) | Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the INR at each time-point. The INR is the ratio of a patient's prothrombin time to a control sample, raised to the power of the ISI value (International Sensitivity Index) for the batch of tissue factor being used for the assay. | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Mean | Full Range | unitless | Through Day 56 |
| ||||||||||||||||||||||||||||||
| Secondary | Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Alanine Aminotransferase (ALT) | Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the ALT at each time-point. | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Mean | Full Range | U/L | Through Day 56 |
| ||||||||||||||||||||||||||||||
| Secondary | Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Total Bilirubin | Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the total bilirubin at each time-point. | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Mean | Full Range | mg/dL | Through Day 56 |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Recurrence of Detectable HCV RNA Post-Transplantation | Serum HCV RNA was measured by Quantitative RT-PCR | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Number | days | Through Day 56 |
|
| ||||||||||||||||||||||||||||||
| Post-Hoc | Time To Viral Rebound Post-Transplantation(Serum HCV RNA Increased ≥ 1 log10 From Viral Nadir) | The time of viral rebound was defined as the time of the first measurement of serum HCV RNA increased ≥ 1 log10 from the viral nadir (the lowest serum HCV RNA level post-transplantation). Serum HCV RNA was measured by RT-PCR. | The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population. | Posted | Mean | Full Range | days | Through Day 56 |
|
Adverse events were assessed from the start of the first infusion through day 56 post-transplantation
Adverse events were assessed by history, physical examinations and laboratory testing through day 56. In addition, the following adverse reactions were specifically solicited through day 42: fever, chills, nausea, rash, joint pain or swelling, shortness of breath, headache, fatigue, and hives.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: MBL-HCV1 | Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation. | 1 | 6 | 6 | 6 | ||
| EG001 | Placebo Comparator: 0.9% Sodium Chloride | Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation. | 4 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Glucose Fluctuation | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal Sounds Abnormal | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis Norovirus | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Viral Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Therapeutic Agent Toxicity | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Albumin Urine Present | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Bacterial Test Positive | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Magnesium Decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood Potassium Decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Clostridium Difficile Toxin Test | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Haematocrit Decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary Casts | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peroneal Nerve Palsy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Genital Haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory Acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Reperfusion Injury | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Affairs | MassBiologics | 617-474-3000 | MBLclinicaldirector@umassmed.edu |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
|
|
|
|
| OG001 |
| Placebo Comparator: 0.9% Sodium Chloride |
Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation. |
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|