An Follow-Up Study of Liver Cirrhosis

NCT ID: NCT03472742

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-07

Study Completion Date

2023-10-12

Brief Summary

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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.

Detailed Description

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Conditions

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Decompensated Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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ADR-001

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rohto Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Niigata University Medical & Dental Hospital

Niigata, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ADR-001-02

Identifier Type: -

Identifier Source: org_study_id

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