Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

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Brief Title

Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

Official Title

Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Pulmonary vascular resistance

Secondary Outcome

 FC

Condition

Pulmonary Hypertension

Intervention

Selexipag

Study Arms / Comparison Groups

 Selexipag
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

October 15, 2020

Completion Date

March 31, 2022

Primary Completion Date

November 30, 2021

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Caio J Fernandes, PHD, 005511992149574, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT04589390

Organization ID

UAP129


Responsible Party

Sponsor

Study Sponsor

University of Sao Paulo General Hospital

Collaborators

 Janssen-Cilag Ltd.

Study Sponsor

Caio J Fernandes, PHD, Principal Investigator, USP


Verification Date

October 2020