Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

NCT04589390 | Unknown Phase 2

• 1 other identifier: UAP129
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension; Schistosomiasis

Keywords

pulmonary arterial hypertension; schistosomiasis; selexipag; treatment; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Pulmonary vascular resistance

  16 weeks

Secondary Outcomes (4)

• FC

  16 weeks

• 6MWT

  16 weeks

• BNP

  16 weeks

• HSP 70

  16 weeks

Other Outcomes (1)

• ESC/ERS risk stratification category

  16 weeks

Study Arms (1)

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).

Drug: Selexipag

Interventions

Selexipag DRUG

treatment with selexipag

Selexipag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, 05048000, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Schistosomiasis; Pulmonary Arterial Hypertension

Interventions

selexipag

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Caio J Fernandes, PHD

  USP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caio J Fernandes, PhD

CONTACT

005511992149574; cjcfernandes@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: October 15, 2020
• Primary Completion: November 30, 2021
• Study Completion: March 31, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)