Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06321705 |
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Expanded Access Status :
Available
First Posted : March 20, 2024
Last Update Posted : March 20, 2024
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| Tracking Information | |||||
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| First Submitted Date | March 14, 2024 | ||||
| First Posted Date | March 20, 2024 | ||||
| Last Update Posted Date | March 20, 2024 | ||||
| Descriptive Information | |||||
| Brief Title | Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension | ||||
| Brief 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. | ||||
| Detailed Description | 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. The exploratory objectives are to evaluate clinical benefit by using Cardio-Microelectromechanical system (CardioMEMS), echocardiography, cardiac magnetic resonance imaging, right heart catheterization, quality of life assessments, and actigraphy to measure changes in clinical response with continued treatment with CS1 in patients with Pulmonary Arterial Hypertension (PAH). Up to 30 patients are planned for enrollment in the ongoing phase 2 Study CS1-003; thus up to 30 patients could participate in Study CS1-004, if they completed the parent study, tolerated CS1 treatment, and in the investigator's judgement the benefits of continued treatment with CS1 outweigh the risk. Note that as the parent study is ongoing; thus, some patients will directly roll- over into Study CS1-004 with no disruption in CS1 treatment, while other patients that have already completed Study CS1-003, will need to be restarted on CS1. On a yearly basis, the principal investigator will determine if a patient continues the expanded access study for a subsequent year based on safety, tolerability, and clinical benefit of CS1. Continuation of the expanded access study will also be evaluated on a yearly basis by Cereno Scientific (Sponsor). |
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| Study Type | Expanded Access | ||||
| Expanded Access Type | Intermediate-size Population, Treatment IND/Protocol | ||||
| Intervention | 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.
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Expanded Access Status | Available | ||||
| Contacts |
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| Listed Location Countries | Sweden | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT06321705 | ||||
| Current Responsible Party | Cereno Scientific AB | ||||
| Original Responsible Party | Same as current | ||||
| Current Study Sponsor | Cereno Scientific AB | ||||
| Original Study Sponsor | Same as current | ||||
| Collaborators |
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| Investigators | Not Provided | ||||
| PRS Account | Cereno Scientific AB | ||||
| Verification Date | March 2024 | ||||