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An Follow-Up Study of Liver Cirrhosis

NCT03472742 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2023-11-18

No results posted yet for this study

Summary

This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study.

Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.

Conditions

  • Decompensated Liver Cirrhosis

Interventions

DRUG

Mesenchymal Stem Cell

As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.

Sponsors & Collaborators

  • Rohto Pharmaceutical Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2023-10-12
Completion
2023-10-12

Countries

  • Japan

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 NCT03472742 on ClinicalTrials.gov