Trials / Completed
CompletedNCT03472742
An Follow-Up Study of Liver Cirrhosis
An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 19 (actual)
- Sponsor
- Rohto Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2018-03-07
- Primary completion
- 2023-10-12
- Completion
- 2023-10-12
- First posted
- 2018-03-21
- Last updated
- 2023-11-18
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03472742. Inclusion in this directory is not an endorsement.