E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
long-term prophylaxis against hepatitis B re-infection ≥ 3 months after liver transplantation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019731 |
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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 |
Main objective of this phase III study is to demonstrate efficacy and safety of two application forms (subcutaneous and intramuscular) of the new human hepatitis B immunoglobulin BT088 in patients after liver transplantation. Trough levels of serum HBs antibody concentrations will be determined in order to ascertain if effective antibody concentrations against a hepatitis B re-infection can be achieved. The pharmacokinetic characteristics of BT088 were evaluated after subcutaneous and intramuscular administration in healthy volunteers in a previous study (study 956).
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E.2.2 | Secondary objectives of the trial |
Moreover the feasibility for the subcutaneous self administration will be assessed.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-male and female patients (age 18-75 years) -≥ 3 months after liver transplantation -HBsAg negative -regular long-term HBIg prophylaxis (combined re-infection prophylaxis) with stabilised HBIg dosage and administration intervals -stable liver function -written informed consent -after the last i.v. administration of HBIg baseline serum HBs antibody concentration ≥200 IU/l – 500 IU/l should be achieved prior to the first dosing of BT088
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E.4 | Principal exclusion criteria |
-pregnancy or unreliable contraceptive measures or lactation period (women only) -known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction) -known intolerance to proteins of human origin -participation in another clinical trial within 30 days before entering the study or during the study and/or previous participation in this study -inability or lacking motivation to participate in the study -selective absolute IgA deficiency -positive HIV or HCV test -unexplained elevation of liver enzymes -ongoing acute rejection episode -severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections -renal insufficiency (dialysis) or other serious organ dysfunctions -life expectancy below 6 months -administration of plasma preparations or other immunoglobulins during the conduct of the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of the present study is to investigate the safety and efficacy of the new preparation BT088 in stable patients during long-term treatment for prophylaxis against re-infection of a transplanted liver. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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 |
two application forms of IMP (SC/IM) |
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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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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Treatment with study medication must be terminated in case of occurrence of study exclusion criteria, a changed risk-benefit ratio according to observed incidence of adverse events in an individual patient or in other patients, and/or for other reasons as severe protocol violations, concomitant diseases/medication influencing the efficacy of study treatment. Moreover, patients have the opportunity to withdraw at any time for personal reasons. [...]
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |