The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI

Active, not recruiting

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT06907693
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-14
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-04-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Participation in the CS1-004 clinical trial

Exclusion Criteria

• Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)
• Individuals who are pregnant or who become pregnant during the sub-study
• eGFR <30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)
• Allergy to Iodine contrast agents

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ratio of BV5A to BV10A	From baseline CT scan to 12 month CT scan	Change from baseline to month 12 in the ratio BV5A/BV10A

Secondary Outcome Measures

Name	Time	Method
Ratio of BV5A to BV5APR	From baseline CT scan to 12 month CT scan	Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable.
Ratio of BV5A to BV5APRA	From baseline CT scan to 12 month CT scan	Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.

Trial Locations

Locations (1)

Prisma Health; 🇺🇸 Greenville, South Carolina, United States