An Follow-Up Study of Liver Cirrhosis

Last updated: March 30, 2023
Sponsor: Rohto Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Scar Tissue

Hepatic Fibrosis

Treatment

N/A

Clinical Study ID

NCT03472742
ADR-001-02
  • Ages > 20
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients evaluated by investigators as inappropriate

Study Design

Total Participants: 21
Study Start date:
March 07, 2018
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8510
    Japan

    Active - Recruiting

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