Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension
NCT06321705 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2024-03-20
Summary
CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1.
Conditions
Interventions
- DRUG
-
CS1
CS1 delayed release capsules will be supplied with 160 mg active pharmaceutical ingredient (API) per capsule. Three dose levels will be administered in this expanded access study at the same dose the patient received in the parent study (CS1-003) of 480 mg, 960 mg, or 1920 mg. All patients will later have the option to be titrated to the most efficacious and safe dose determined from the ongoing CS1-003 study when completed.
Sponsors & Collaborators
-
Worldwide Clinical Trials
collaborator OTHER - collaborator INDUSTRY
-
Cereno Scientific AB
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- Sweden
Study Locations
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