E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PROPHYLAXIS OF HEPATITIS B REINFECTION AFTER LIVER TRANSPLANTATION |
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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 | 10058827 |
E.1.2 | Term | Hepatitis B reactivation |
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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 |
Investigation of safety of the subcutaneous (s.c.) application of BT088 in patients after liver transplantation |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
 male and female patients (age 18-75 years)  ≥ 3 months after liver transplantation  HBsAg negative/ HBV-DNA negative in two determinations during the last 3 months  after the last i.v. or i.m. administration of HBIg serum HBs antibody concentration between 200 IU/L and 350 IU/L prior to the first dosing of BT088 at day 1  regular long-term i.v. or i.m. HBIg prophylaxis (combined re-infection prophylaxis) with stabilised HBIg dosage and administration intervals with i.v. or i.m hepatitis B immunoglobulins  stable liver function  written informed consent |
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E.4 | Principal exclusion criteria |
 bilirubin ≥ 2 mg /dL, albumin less than 2 g/dL, ascites, protrombin less that 70% , ALAT / ASAT / GGT / AP ≥ 2 times ULN (upper limit of normal )  patients who are known to be HBV-DNA positive  hepatocarcinoma (hepatocellular carcinoma)  positive HIV or HCV test  unexplained elevation of liver enzymes  ongoing acute rejection episode  severe thrombocytopenia or any coagulation disorder that would contraindicate injections  pregnancy or unreliable contraceptive measures or lactation period (females only)  known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)  known intolerance to proteins of human origin  selective absolute Ig A deficiency  renal insufficiency (dialysis) or other serious organ dysfunctions  life expectancy below 6 months  suspicion of drug and / or alcohol abuse  inability or lacking motivation to participate in the study  participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study  the patient planned to be enrolled is an employee of any involved investigator or any involved institution including the sponsor of the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
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) | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | 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
| |
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |