E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Spntaneous bacterial peritonitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001558 |
E.1.2 | Term | Albumin |
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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 |
We hypothesize that infusion of albumin can improve endotoxin binding capacity and thereby prevent inappropriate neutrophil activation and neutrophil dysfunction in patients with spontaneous bacterial peritonitis. Therefore we aim to investigate neutrophil function (oxidative burst) before, during and after high-dose albumin infusions as compared to standard therapy. |
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E.2.2 | Secondary objectives of the trial |
1) Increase in phagocytic capacity of neutrophils 2) Increase in endotoxin binding capacity 3) Improvement of albumin function and parameters of oxidative damage 4) Occurrence of the organ failure (one or more of the following) a. Hepatic Encephalopathy: Grade > 2 according to the West-Haven criteria. b. Renal Failure: Defined as an increase in serum creatinine level by more than 50 percent of the pretreatment value, to levels higher than 200umol/L. In patients with preexisting renal dysfunction (creatinine>100umol/L), an increase in serum creatinine level by more than 50 percent. c. Requirement of inotropic support to keep mean arterial pressure greater than 60 mmHg. 5) 3-month mortality 6) Length of hospital stay
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with a clinical, radiological and/or histological evidence of cirrhosis and a polymorphonuclear-cell count in the ascitic fluid of more than 250 per cubic millimeter (spontaneous bacterial peritonitis, SBP) • Age above 18
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E.4 | Principal exclusion criteria |
• findings suggestive of secondary peritonitis • antibiotic treatment within one week before the diagnosis of spontaneous bacterial peritonitis (except for prophylactic treatment with norfloxacin/levofloxacin) • presence of infections other than spontaneous bacterial peritonitis • gastrointestinal bleeding within last 14 days • ileus • shock, cardiac failure (inotrope requirement) • hepatic encephalopathy grade >2 • findings suggestive of organic nephropathy or a serum creatinine level of no more than 150 µmol per liter • human immunodeficiency virus infection • any disease (e.g., advanced neoplasia) that could affect the short-term prognosis • potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment) within one week before the diagnosis of peritonitis.
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E.5 End points |
E.5.1 | Primary end point(s) |
Decrease in resting oxidative burst of neutrophils |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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Last visit of last patient |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |