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Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension (SELSCH)

Primary Purpose

Pulmonary Hypertension, Schistosomiasis

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Selexipag
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary arterial hypertension, schistosomiasis, selexipag, treatment, efficacy, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade de São PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Selexipag

Arm 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).

Outcomes

Primary Outcome Measures

Pulmonary vascular resistance

Secondary Outcome Measures

FC
New York Heart Association Functional Class
6MWT
Lenght in the six minute walking distance test
BNP
Brain Natriuretic Peptide
HSP 70
Heat shock protein 70

Full Information

First Posted
October 8, 2020
Last Updated
October 8, 2020
Sponsor
University of Sao Paulo General Hospital
Collaborators
Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04589390
Brief Title
Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension
Acronym
SELSCH
Official Title
Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Janssen-Cilag Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Schistosomiasis
Keywords
pulmonary arterial hypertension, schistosomiasis, selexipag, treatment, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selexipag
Arm Type
Other
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Selexipag
Intervention Description
treatment with selexipag
Primary Outcome Measure Information:
Title
Pulmonary vascular resistance
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
FC
Description
New York Heart Association Functional Class
Time Frame
16 weeks
Title
6MWT
Description
Lenght in the six minute walking distance test
Time Frame
16 weeks
Title
BNP
Description
Brain Natriuretic Peptide
Time Frame
16 weeks
Title
HSP 70
Description
Heat shock protein 70
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
ESC/ERS risk stratification category
Description
ESC/ERS risk stratification category
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patient without clinical condition to perform the 6-minute walk test Patient with gastro-intestinal bleeding for over 12 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caio J Fernandes, PhD
Phone
005511992149574
Email
cjcfernandes@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caio J Fernandes, PHD
Organizational Affiliation
USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05048000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caio Fernandes, PhD
Phone
011-992149574
Email
cjcfernandes@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

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