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An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis
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.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Niigata University Medical & Dental Hospital
Niigata, Japan
Start Date
March 7, 2018
Primary Completion Date
October 12, 2023
Completion Date
October 12, 2023
Last Updated
November 18, 2023
19
ACTUAL participants
Mesenchymal Stem Cell
DRUG
Lead Sponsor
Rohto Pharmaceutical Co., Ltd.
NCT06212635
NCT07002827
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03529136