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Cells of Monocytic Origin as Surrogate Markers for Individual Drug Effects and Hepatotoxicity

NCT02353455 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2019-11-26

No results posted yet for this study

Summary

Drug metabolism in the liver is subject to large fluctuations (differences between women and men, people of different ethnic backgrounds, children and adults). These large differences are responsible for very different drug effects and side-effects (and especially liver damage caused by drugs) between individuals. Recent scientific findings suggest that blood derived cells can be used to model individual effects of drugs on the liver reflect inter-individual differences. Since liver damage caused by drugs is a diagnosis of exclusion, the aforementioned cells can be used to identify patients that show higher sensitivity to hepatotoxic side-effects and - in case several drugs are involved - identify the causal agent or possible interactions.

Conditions

  • Drug-induced Disorder of Liver
  • Adverse Reaction to Drug

Interventions

PROCEDURE

Blood sampling

In each group a blood sample of approximately 50 mL will be obtained upon study inclusion.

Sponsors & Collaborators

  • MetaHeps GmbH

    collaborator UNKNOWN

  • Andreas Benesic, MD

    lead OTHER

Principal Investigators

  • Alexander L Gerbes, Prof. MD · Liver Center Munich®, Internal Medicine II, Ludwig-Maximilians University Hospital, Campus Grosshadern, Munich; Marchioninistr. 15; D81377 Munich, Germany

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2020-03-31
Completion
2022-08-31

Countries

  • Australia
  • Germany
  • Hong Kong
  • Japan
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02353455 on ClinicalTrials.gov