Pulmonary Arterial HypertensionNCT06321705
Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension
A study testing CS1 in people with Pulmonary Arterial Hypertension, run by Cereno Scientific AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- CS1
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patient has derived benefit from CS1 treatment in parent Study CS1-003 based on the Investigator's judgement and the benefit of continued CS1 treatment outweighs the risk or the patient could benefit from continued treatment with CS1.
- Patient must be willing and able to sign a written informed consent prior to any study-related procedures and able to understand and follow instructions; return to the study unit for specified study visits; and able to participate in the study for the entire period.
- Patient is classified as New York Heart Association/World Health Organisation (NYHA/WHO) functional Class I, II or III.
- Patient has CardioMEMS PA Sensor implanted and has completed treatment per parent protocol in Phase 2 Study CS1-003.
- Female patient of childbearing potential must be willing and able to practice effective contraception during the study and continuing contraception for 30 days after their last dose of study drug. A female patient of non-childbearing potential is defined as being surgically sterilized by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. A female patient 45 to 60 years of age, who is post-menopausal for at least 1 year, and has a follicle-stimulating hormone level confirmation indicating post menopausal status will be considered of non-childbearing potential. A female patient >60 years of age is considered post menopausal and of non childbearing potential.
Who cannot join
- Patient has a concomitant medical disorder that is expected to limit the patient's life-expectancy to ≤1 year.
- Patient has thrombocytopenia: platelets <100,000/mm3.
- Patient has a recent history of pancreatic disease.
- Patient is a pregnant or lactating female.
- Patient has active coronavirus disease 19 (COVID-19); however, those with previous COVID 19 are permitted.
- Patient is participating in another investigational study which, in the opinion of the Investigator, would interfere with the study compliance or outcome assessments.
Show all 15Show fewer
- Patient is on regular treatment with other anti-epilepsy drugs or other prohibited medications (See Section 6.8.1) that cannot be discontinued at Roll-over or Restart Visit (V1).
- Patient is on regular anticoagulation or on antiplatelet therapy that cannot be discontinued. A low daily dose aspirin (<125 mg) is allowed, ie, "baby" aspirin.
- Patient has significant liver dysfunction as measured by any one of the following at Roll-over or Restart Visit (V1) (including patients with acute or chronic hepatitis as well as patients with own or family history of serious hepatitis, especially drug related):
- Alanine aminotransferase (ALT) >2.0 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST) >2.0 × ULN.
- Serum bilirubin ≥1.6 mg/dL or >2.0 × ULN.
- Patient with any major surgical procedure or trauma within 30 days prior to Roll-over or Restart Visit (V1) or planned surgical procedure during the study period.
- Patient has known hypersensitivity to study drug or any of the excipients of the drug formulation.
- Patient prematurely discontinued CS1 treatment in parent Study CS1-003 due to safety concerns of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanded Access, Open-Label, Safety Extension Study for Patients That Have Completed Parent Study CS1-003 and Who Are Judged by the Investigator to Benefit From Continued CS1 Treatment
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.
Read the 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).
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- CS1
- Keywords
- Pulmonary Arterial Hypertension, CardioMEMS
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1Drug
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cereno Scientific AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321705
- Sponsor's protocol ID
- CS1-004
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access, Open-Label, Safety Extension Study for Patients That Have Completed Parent Study CS1-003 and Who Are Judged by the Investigator to Benefit From Continued CS1 Treatment
- ClinicalTrials.gov ID
- NCT06321705
- Acronym / sponsor ID
- CS1-004
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension, CardioMEMS
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Cereno Scientific ABIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Abbott
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has derived benefit from CS1 treatment in parent Study CS1-003 based on the Investigator's judgement and the benefit of continued CS1 treatment outweighs the risk or the patient could benefit from continued treatment with CS1.
- Patient must be willing and able to sign a written informed consent prior to any study-related procedures and able to understand and follow instructions; return to the study unit for specified study visits; and able to participate in the study for the entire period.
- Patient is classified as New York Heart Association/World Health Organisation (NYHA/WHO) functional Class I, II or III.
- Patient has CardioMEMS PA Sensor implanted and has completed treatment per parent protocol in Phase 2 Study CS1-003.
- Female patient of childbearing potential must be willing and able to practice effective contraception during the study and continuing contraception for 30 days after their last dose of study drug. A female patient of non-childbearing potential is defined as being surgically sterilized by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. A female patient 45 to 60 years of age, who is post-menopausal for at least 1 year, and has a follicle-stimulating hormone level confirmation indicating post menopausal status will be considered of non-childbearing potential. A female patient >60 years of age is considered post menopausal and of non childbearing potential.
Key exclusion criteria (15 listed)
- Patient has a concomitant medical disorder that is expected to limit the patient's life-expectancy to ≤1 year.
- Patient has thrombocytopenia: platelets <100,000/mm3.
- Patient has a recent history of pancreatic disease.
- Patient is a pregnant or lactating female.
- Patient has active coronavirus disease 19 (COVID-19); however, those with previous COVID 19 are permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS1CS1 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS1 in people with Pulmonary Arterial Hypertension, run by Cereno Scientific AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.