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An Follow-Up Study of Liver Cirrhosis

R

ROHTO Pharmaceutical

Status

Completed

Conditions

Decompensated Liver Cirrhosis

Treatments

Drug: Mesenchymal Stem Cell

Study type

Observational

Funder types

Industry

Identifiers

NCT03472742
ADR-001-02

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
  • Voluntary signed informed consent

Exclusion criteria

  • Patients evaluated by investigators as inappropriate

Trial contacts and locations

1

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Central trial contact

Rohto Pharmaceutical Co., Ltd.

Data sourced from clinicaltrials.gov

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