Pulmonary HypertensionPhase 2SELSCHNCT04589390
Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension
A Phase 2 study testing Selexipag in people with Pulmonary Hypertension and Schistosomiasis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Pulmonary arterial hypertension (PAH) is a severe, progressive and potentially fatal disease that impairs the pulmonary circulation and leads to right ventricular failure. One of the world most prevalent etiologies of PAH is schistosomiasis-associated pulmonary arterial hypertension (Sch-PAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Schistosomiasis
- What is being tested?
- Selexipag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Oct 2020to 31 Mar 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic Sch-PAH. Sch-PAH diagnosis necessarily include the three criteria below
- Invasive confirmation of PAH, according to the criteria defined in the Pulmonary Hypertension Sixth World Symposium: mean pulmonary artery pressure higher than 20 mmHg, at rest, and the presence of pulmonary vascular resistance (PVR) equal to or greater than 3 W, and a pulmonary capillary pressure considered normal (equal to or lower than 15 mmHg (1)).
- At least one epidemiological criteria for chronic schistosomiasis: patient from a highly prevalent region for schistosomiasis or previous history of parasitic treatment for schistosomiasis or the presence of Schistosoma mansoni eggs in the patient's feces
- Evidence of long-term hepatosplenic involvement by schistosomiasis, via compatible ultrasound findings (peri-portal fibrosis or enlarged left lobe) All patients will necessarily already be receiving at least one specific treatment for PAH, either with phosphodiesterase V inhibitor or with an endothelin receptor antagonist, with a stable dose for at least 12 weeks before inclusion in the study.
Who cannot join
- Patient without clinical condition to perform the 6-minute walk test
- Patient with gastro-intestinal bleeding for over 12 weeks
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade de São Paulo
São Paulo, São Paulo, 05048000
Caio Fernandes, PhD, 011-992149574, cjcfernandes@yahoo.com.br
About this study
Pulmonary arterial hypertension (PAH) is a severe, progressive and potentially fatal disease that impairs the pulmonary circulation and leads to right ventricular failure. One of the world most prevalent etiologies of PAH is schistosomiasis-associated pulmonary arterial hypertension (Sch-PAH). New drugs have emerged to treat other forms of PAH, but their benefits cannot be automatically translated for Sch-PAH patients, since this etiology was not included in the pivotal PAH trials. One of the most promising therapies for the treatment of PAH to emerge in recent years is selexipag, an oral IP receptor agonist, which acts on the prostacyclin pathway. The present study aims to evaluate the efficacy, safety and tolerability of selexipague for the treatment of schistosomiasis-associated pulmonary arterial hypertension.
- Conditions
- Pulmonary Hypertension, Schistosomiasis
- Being tested
- Selexipag
- Keywords
- pulmonary arterial hypertension, schistosomiasis, selexipag, treatment, efficacy, safety
- Medical subject headings
- Hypertension, Pulmonary, Schistosomiasis, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelexipagDrug
treatment with selexipag
| Study group | Role | What they receive |
|---|---|---|
| Selexipag | Other | Selexipag will be up titrated for a period that will last 12 weeks (Phase 2). The initial dose will be 200 mcg of selexipag every 12 hours, with weekly dose increases of 200 mcg, up to the maximum dose of 1600 mcg every 12 hours or until the classic side effects of the prostacyclin pathway drugs (headache, mandibular pain), among others) arise. The dose will then be reduced by 200 mcg per dose, and this will be the maximum dose considered for that particular patient, maintained in Phase 3 (16 weeks). Receives: Drug: Selexipag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular resistance
Measured: 16 weeks
Secondary outcomes (4)
FC
New York Heart Association Functional Class
Measured: 16 weeks
6MWT
Lenght in the six minute walking distance test
Measured: 16 weeks
BNP
Brain Natriuretic Peptide
Measured: 16 weeks
HSP 70
Heat shock protein 70
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluation of hemodynamics and surrogate markers (clinical variables, BNP levels, six-minute walking test distance, and heat shock protein 70 levels) before and after the introduction of selexipag for the treatment of schistosomiasis-associated pulmonary arterial hypertension patients, that were already receiving at least one therapy for pulmonary arterial hypertension, excluding other drugs from the prostacyclin pathway.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
- Investigators
- Caio J Fernandes, PHD, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589390
- Sponsor's protocol ID
- UAP129
- Acronym
- SELSCH
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04589390
- Acronym / sponsor ID
- SELSCH / UAP129
- Conditions
- Pulmonary Hypertension, Schistosomiasis
- Keywords
- pulmonary arterial hypertension, schistosomiasis, selexipag, treatment, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 19 Oct 2020 (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.
Pulmonary arterial hypertension (PAH) is a severe, progressive and potentially fatal disease that impairs the pulmonary circulation and leads to right ventricular failure. One of the world most prevalent etiologies of PAH is schistosomiasis-associated pulmonary arterial hypertension (Sch-PAH). New drugs have emerged to treat other forms of PAH, but their benefits cannot be automatically translated for Sch-PAH patients, since this etiology was not included in the pivotal PAH trials. One of the most promising therapies for the treatment of PAH to emerge in recent years is selexipag, an oral IP receptor agonist, which acts on the prostacyclin pathway. The present study aims to evaluate the efficacy, safety and tolerability of selexipague for the treatment of schistosomiasis-associated pulmonary arterial hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluation of hemodynamics and surrogate markers (clinical variables, BNP levels, six-minute walking test distance, and heat shock protein 70 levels) before and after the introduction of selexipag for the treatment of schistosomiasis-associated pulmonary arterial hypertension patients, that were already receiving at least one therapy for pulmonary arterial hypertension, excluding other drugs from the prostacyclin pathway.
| Arm | Type | Receives |
|---|---|---|
| Selexipag | Other | Drug: SelexipagSelexipag will be up titrated for a period that will last 12 weeks (Phase 2). The initial dose will be 200 mcg of selexipag every 12 hours, with weekly dose increases of 200 mcg, up to the maximum dose of 1600 mcg every 12 hours or until the classic side effects of the prostacyclin pathway drugs (headache, mandibular pain), among others) arise. The dose will then be reduced by 200 mcg per dose, and this will be the maximum dose considered for that particular patient, maintained in Phase 3 (16 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with symptomatic Sch-PAH. Sch-PAH diagnosis necessarily include the three criteria below
Key exclusion criteria (2 listed)
- Patient without clinical condition to perform the 6-minute walk test
- Patient with gastro-intestinal bleeding for over 12 weeks
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 |
|---|---|---|
| Selexipagtreatment with selexipag | Drug | Selexipag |
Primary outcome
Pulmonary vascular resistance
Time frame: 16 weeks
4 secondary outcomes
FC
Time frame: 16 weeks
6MWT
Time frame: 16 weeks
BNP
Time frame: 16 weeks
HSP 70
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Caio J Fernandes, PHD principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selexipag in people with Pulmonary Hypertension and Schistosomiasis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 2 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 19 Oct 2020. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Caio J Fernandes, PhD (005511992149574, cjcfernandes@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary vascular resistance (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
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 19 Oct 2020.