E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with both chronic hepatitis B and hepatocellular carcinoma. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with both chronic hepatitis B and hepatocellular carcinoma. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008910 |
E.1.2 | Term | Chronic hepatitis B |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10073071 |
E.1.2 | Term | Hepatocellular carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
• Quantification of the magnitude of the effect of ≥6-week treatment with Hepatitis B immunoglobulins in patients with chronic hepatitis B and HCC, determined by the HBsAg reduction after week 6 • Evaluation of the safety and tolerability of Hepatitis B immunoglobulins administered for ≥6-weeks in patients with chronic hepatitis B and HCC |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include the biochemical response of the HCC and the immune system, as well as the evaluation of HBsAg kinetics during treatment with hepatitis B Immunoglobulins. Analyses will include comparison of tissue samples from liver biopsies before and after treatment with Hepatitis B immunoglobulins as well as monitoring of the peripheral response of the immune system at different time points during treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Willing and able to provide written informed consent 2. HBsAg-positive HCC-patients scheduled for resection in ≥6 weeks or HBsAg-positive HCC-patients listed for LT |
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E.4 | Principal exclusion criteria |
1. Clinically significant illness (other than HBV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment. 2. No eligibility for resection / LT 3. Concurrent any other malignancy 4. Co-infection with hepatitis C virus (defined as HCV RNA positive, HCV RNA-negative / anti-HCV-positive patients can be included) and/or human immunodeficiency virus (HIV) 5. Clinical hepatic decompensation 6. Allergy to HBIG |
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E.5 End points |
E.5.1 | Primary end point(s) |
HBsAg change from baseline to week 6 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- HBsAg decrease at different time points during treatment - Biochemical response: • HCC-response to treatment (size, cellular response, response of immune cells within the biopsy material) • Immune responses during HBIG treatment (analysis of T cells, NK cells, B cells) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Weekly during the treatment period (6 weeks) and during the follow up at 2 weeks, 4 weeks, 6 weeks and 8 weeks after treatment stop |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |