Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
Abstract
In this Annual Report, we report the successes with and ongoing challenges to initiation of the SEPVADIS Study. In the report period, we finalized our manual of procedures and case report forms. We have created and tested a relational database in the Red Cap system. We conducted a mock patient run-through of the study procedures and protocols. We have established our Data Safety and Monitoring Board. We have confirmed production of study drug and placebo with the Johns Hopkins Investigational Drug Service. We have established and finalized all subcontracts. Most importantly, we have received approval from our Institutional Review Board and the Human Research Protections Office for initiation of the study. With these approvals, we have begun active screening for eligible participants through our recruitment pools at the Johns Hopkins Pulmonary Hypertension Program and the Johns Hopkins Scleroderma Center. We have identified candidates and have approached our first potential subject. We hope to enroll our first subject before the end of the calendar year.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1168861
Entities
People
- Stephen C. Mathai
Organizations
- Johns Hopkins University