JRCT ID: jRCT2033220602
Registered date:01/02/2023
ADR-001-N2
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Compensated liver cirrhosis (Child-Pugh A) |
| Date of first enrollment | 14/02/2023 |
| Target sample size | 9 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The amount of change in Albumin-bilirubin (ALBI) score |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1)Patients who received at least one dose of ADR-001 in the ADR-001-N1 Study. 2)Patients capable of giving written informed consent. |
| Exclude criteria | 1)Patients decided to be ineligible for this study by the investigator. |
Related Information
| Primary Sponsor | Terai Shuji |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | ROHTO Pharmaceutical Co., Ltd. |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yusuke Watanabe |
| Address | 754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata Niigata Japan 951-8520 |
| Telephone | +81-25-227-2207 |
| ywatanabe19840421@med.niigata-u.ac.jp | |
| Affiliation | Niigata University Medical and Dental Hospital |
| Scientific contact | |
| Name | Shuji Terai |
| Address | 754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata Niigata Japan 951-8520 |
| Telephone | +81-25-227-2207 |
| terais@med.niigata-u.ac.jp | |
| Affiliation | Niigata University Medical and Dental Hospital |