Double-blind, randomized, placebo-controlled, study to evaluate the safety and efficacy of HRX215 in participants after major hepatectomy, preceded by two open pilot parts in participants after minor and after major hepatectomy due to colon carcinoma metastases
Phase 2 – studying effectiveness and dosage
Conditions:
colon carcinoma metastases
Sponsor: HepaRegeniX GmbH
trial.available_in:
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Overview
Trial status: Authorised
Establishment of Efficacy (main study part 3): • Liver volume on POD1 and POD7 and increase in liver volume at POD7 vs. POD1 (absolute change from POD1 CT)
Incidence, severity, and relatedness of AEs/SAEs, Changes from baseline in vital signs and physical examination findings, Changes from baseline in clinical laboratory parameters (hematology,blood, glucose) at prespecified time points, Plasma PK of HRX215 (Cmax, Tmax, AUC etc.); comparison with Phase 1 healthy-subject PK data
Description
Establishment of Efficacy (main study part 3): • Liver volume on POD1 and POD7 and increase in liver volume at POD7 vs. POD1 (absolute change from POD1 CT)
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 29 participants
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