JRCT ID: jRCT1011210052
Registered date:26/11/2021
Anti-fibrotic effects of the IP receptor agonist
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | pulmonary arterial hypertension associated with systemic sclerosis |
| Date of first enrollment | 26/11/2021 |
| Target sample size | 20 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The change in normal lung volume or fibrotic lung volume from baseline (*) to week 52, determined by quantitative chest CT *: 12 or less week before the administration of selexipag |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1. Males and females aged 18 or more 2. Needs to be treated with selective pulmonary vasodilators 3. Capable of giving signed informed consent |
| Exclude criteria | 1. Lactating or pregnant females 2. Strongly suspected of structural brain abnormality 3. Unable to undergo the proper procedure of chest CT 4. Needs to be treated with anti-fibrotic drugs 5. Prior or current receipt of anti-fibrotic drugs 6. Inappropriate in the option of the Investigator |
Related Information
| Primary Sponsor | Atsumi Tatsuya |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nippon Shinyaku Co., Ltd. |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Masaru Kato |
| Address | N14W5, Kita-Ku, 060-8648 Sapporo, Japan Hokkaido Japan 060-8648 |
| Telephone | +81-11-706-5916 |
| ktmasaru@med.hokudai.ac.jp | |
| Affiliation | Hokkaido University Hospital |
| Scientific contact | |
| Name | Tatsuya Atsumi |
| Address | N14W5, Kita-Ku, 060-8648 Sapporo, Japan Hokkaido Japan 060-8648 |
| Telephone | +81-11-706-5916 |
| at3tat@med.hokudai.ac.jp | |
| Affiliation | Hokkaido University Hospital |