Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04589390
• Date of registration: 08/10/2020
• Prospective Registration: Yes
• Primary sponsor: University of Sao Paulo General Hospital
• Public title: Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension SELSCH
• Scientific title: Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension
• Date of first enrolment: October 15, 2020
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04589390
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Brazil

Contacts

• Name: Caio Fernandes, PhD

• Name: Caio J Fernandes, PhD

• Name: Caio J Fernandes, PHD
• Affiliation: USP

Key inclusion & exclusion criteria

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:

- Patient without clinical condition to perform the 6-minute walk test

- Patient with gastro-intestinal bleeding for over 12 weeks



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Schistosomiasis

Intervention(s)

Drug: Selexipag

Primary Outcome(s)

Pulmonary vascular resistance [Time Frame: 16 weeks]

Secondary Outcome(s)

6MWT [Time Frame: 16 weeks]

BNP [Time Frame: 16 weeks]

FC [Time Frame: 16 weeks]

HSP 70 [Time Frame: 16 weeks]

Secondary ID(s)

UAP129

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen-Cilag Ltd.