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Status unknownNCT04589390SELSCHUpdated Oct 19, 2020

Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

A Phase 2 interventional study of Selexipag in Pulmonary Hypertension and Schistosomiasis, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.

Primary conditionPulmonary Arterial HypertensionRegistry: Hypertension, PulmonaryReclassifiedWhy we changed it
Registry
Hypertension, Pulmonary — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pulmonary Arterial Hypertension
Why
  1. The study's title name Pulmonary Arterial Hypertension, a narrower term within Hypertension, Pulmonary.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Pulmonary Hypertension
  • Schistosomiasis

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Keywords

  • pulmonary arterial hypertension
  • schistosomiasis
  • selexipag
  • treatment
  • efficacy
  • safety
03

In context

Pulmonary Arterial Hypertension Reclassified

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse University of Sao Paulo General Hospital studies →

Compared within Pulmonary Arterial Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension, Pulmonary. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with symptomatic Sch-PAH. Sch-PAH diagnosis necessarily include the three criteria below

    1. 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)).
    2. 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
    3. 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.

Exclusion criteria

Exclusion Criteria:

  • Patient without clinical condition to perform the 6-minute walk test
  • Patient with gastro-intestinal bleeding for over 12 weeks
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Selexipag

    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).

    Drug: Selexipag

Interventions

06

What researchers measure

Primary outcomes

  1. Pulmonary vascular resistance

    Time frame: 16 weeks

Secondary outcomes

  1. FC

    New York Heart Association Functional Class

    Time frame: 16 weeks

  2. 6MWT

    Lenght in the six minute walking distance test

    Time frame: 16 weeks

  3. BNP

    Brain Natriuretic Peptide

    Time frame: 16 weeks

  4. HSP 70

    Heat shock protein 70

    Time frame: 16 weeks

Other outcomes

  1. ESC/ERS risk stratification category

    ESC/ERS risk stratification category

    Time frame: 16 weeks

07

Study locations

1 of 1 sites recruiting
  • Universidade de São Paulo
    São Paulo, SP 05048000, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2020; primary completion for Nov 2021, 13 months later.

Of 51 phase 2 interventional studies under Pulmonary Arterial Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 65. This study's planned 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2020
First posted
Oct 19, 2020
StartEst.
Oct 15, 2020
Primary completionEst.
Nov 30, 2021
CompletionEst.
Mar 31, 2022
Last update
Oct 19, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04589390
Lead sponsor
University of Sao Paulo General Hospital
Collaborators
Janssen-Cilag Ltd.
Responsible party
Sponsor
First posted
Oct 19, 2020
Start date
Oct 15, 2020 (estimated)
Primary completion
Nov 30, 2021 (estimated)
Completion
Mar 31, 2022 (estimated)
Last update
Oct 19, 2020

Study contacts

Caio J Fernandes, PhD
Contact
cjcfernandes@yahoo.com.br
005511992149574
Caio J Fernandes, PHD
principal investigator · USP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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