ADR-001-N1

Phase 2

• Conditions: Compensated liver cirrhosis (Child-Pugh A)

• Registration Number: JPRN-jRCT2033210425
• Lead Sponsor: Terai Shuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1) Men and Women >= 20 years old of age on the date of consent.
2) Patient with cirrhosis any of the following criteria.
F4 cirrhotic patients diagnosed by previous liver biopsy.
F4 cirrhotic patients diagnosed by MR elastography.
F4 cirrhotic patients diagnosed by ultrasound elastography.
3) Patients with cirrhosis any of the following criteria.
Alcoholic steatohepatitis, abstaining from alcohol for more than 6 months.
Non-alcoholic steatohepatitis, on exercise and diet therapy for more than 6 month.
Chronic hepatitis B, with negative for HBV-DNA for at least 6 months after a treatment with nucleic acid analogues.
Past Chronic hepatitis C, attained a sustained virological response by antiviral therapy for more than 12 months.
4) Child-Pugh score: 6 points or less.
5) Patients capable of giving written informed consent.

Exclusion Criteria

1) Malignancy (except relapse-free survival >5 years).
2) Gastroesophageal varices to treat.
3) History of venous thrombosis or pulmonary embolism.
4) A neutrophil count below the lower limit of the reference.
5) D-dimer level >=3.0 microgram/mL or FDP level >= 15 microgram/mL
6) Serum creatinine level >= 2.0 mg/dL
7) Serum total-bilirubin level >= 5.0 mg/dL
8) Patients experienced transplantation or cell therapy, previously.
9) Pregnancy, lactation, or desire to have children in study period.
10) Severe cardiovascular, renal, or respiratory disease.
11) Alcoholic liver cirrhosis patients with The Alcohol Use Disorders Identification Test (AUDIT) >=8 points.
12) Inadequate physical condition, as diagnosed by their physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of change in Albumin-bilirubin (ALBI) score