E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study will look at the liver metabolic function in patients with acute liver failure. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study aims to provide data on a novel system to dynamically and accurately assess liver function at the bed side. It is hoped that the system will provide prognostic information faster than is achieved at present with traditional methods. This, in the future may have an impact on decision making and clinical practice, allowing earlier listing for transplantation in the sickest group of patients, allowing greater chance of liver transplant and hence survival. In those patients who do not need liver transplantation it should allow earlier recognition of improvement and hence facilitate earlier discharge from hospital |
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E.2.2 | Secondary objectives of the trial |
An additional objective is safety evaluation through assessment of BreathID system (device and drug) related adverse events. Any adverse events will be reported according to GCP guidelines.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria
1. Adult men or women (>18 years of age). 2. Acute Liver insult 3. No evidence of cirrhosis (unless clinical acute Wilsons) 4. INR > 1.8 5. Duration of illness < 12 and 24 weeks
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E.4 | Principal exclusion criteria |
Exclusion Criteria
1. Patient with any chronic liver disease 2. Patient has severe congestive heart failure 3. Patient has severe pulmonary hypertension 4. Patient has chronic renal insufficiency with severe cardiac disease 5. Patient has previous surgical bypass surgery for morbid obesity 6. Patient has extensive small bowel resection 7. Patient with any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication 8. Patient is a recipient of any organ transplant 9. Patient with proven or suspected hepatocellular carcinoma 10. Patient is pregnant 11. Patient allergic to acetaminophen (such as Tylenol or any other related medications) 12. Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma 13. Patients with septic cholestasis 14. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs 15. Patients that are taking hepatotoxin drugs 16. Patient, based on the opinion of the investigator, should not be enrolled into this study 17. Patients unable or unwilling to sign informed consent 18. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Exclusion Criteria (Day of MBT)
1. Patient has not fasted for 8 hours 2. Patient has smoked on the day of the test 3. Patient that has taken drugs that can interfere with methacetin metabolism : fluvoxamine, amiodarone, ciprofloxacin, cimetidine, rifampin, carbamazepine within the last 24 hours 4. Patient has taken Tylenol or any other acetaminophen related medications within the past 24 hours 5. Patients that received general anesthesia or conscious sedation in the last 24 hours 6. Patient has consumed alcohol within the past 24 hours 7. Patients that still suffer from any previous clinical intervention (e.g. biopsy)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point of the study is to evaluate the ability of the MBT to predict earlier than current prognostic models and clinical parameters trends of improvement or deterioration based on breath test parameters alone or in conjunction with other clinical data compared to the clinical outcome (recovery, death, transplant). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial will be defined as the last patient last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |