Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

Pulmonary Arterial Hypertension Clinical Trial

Official title:

An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112487
• Other study ID #: AC-055-311
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2014
• Est. completion date: September 19, 2018

Study information

• Verified date: September 2019
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.

To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

Description:

To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 19, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure.

2. Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled

3. Women of childbearing potential (as defined below) must:

• Have a negative serum pregnancy test at Visit 1 (i.e., Visit 4 of study AC 055 310) and agree to perform monthly serum pregnancy tests.

• Agree to use two reliable methods of contraception in parallel, from Visit 1 until 1 month after study drug discontinuation (see details below).

• A female is considered to have childbearing potential unless she meets at least one of the following criteria:

• Previous bilateral salpingo and/or oophorectomy, or hysterectomy.

• Premature ovarian failure confirmed by a specialist.

• Pre-pubescence, XY genotype, Turner syndrome, uterine agenesis.

• Postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause.

• Of the two contraceptive methods that must be used, one must be from Group 1, and one must be from Group 2, defined as follows:

• Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non-surgical sterilization, e.g., permanent contraception with Essure procedure), or partner's sterilization (vasectomy). If a hormonal contraceptive is chosen from this group, it must be taken for at least one month prior to enrollment. Alternatively, if the Essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations).

• Group 2: Female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide.

• Sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study.

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-055-310.

2. Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.

3. AST and/or ALT more than 3 X ULN.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Macitentan
10 mg once daily

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron Cedex
France	Hôpital Côte de Nacre	Caen
France	Hôpital Albert Michallon	Grenoble
France	CHU de Bicêtre	Le Kremlin-Bicêtre
France	CHRU Lille - Hôpital Cardiologique	Lille
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Hôpitaux de Brabois	Nancy
France	Hôpital de Haut Levêque	Pessac
France	Hôpital Pontchaillou	Rennes
France	Hôpital Charles Nicolle	Rouen
France	Hôpital Nord	Saint-Etienne
France	Hôpital Civil	Strasbourg
France	Hôpital Larrey	Toulouse
Italy	Ospedale Sant'Orsola	Bologna
Italy	A.O.U.C. Careggi	Firenze
Italy	Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare	Rome
Italy	UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica	Rome
Italy	Policlinico G.B. Rossi	Verona
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Clinic	Barcelona
Spain	Hospital Val Hebron	Barcelona
Spain	Hospital de Cruces	Bilbao
Spain	Hospital Reina Sofia	Córdoba
Spain	Hospital Dr Negrin	Las Palmas de Gran Canaria
Spain	Hospital Universitario Insular Gran Canarias	Las Palmas de Gran Canaria
Spain	Hospital 12 Octubre	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Son Espases	Palma de Mallorca
Spain	Hospital de Valdecilla	Santander
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Hospita General U. Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.	Treatment-emergent adverse events (AEs); AEs leading to premature discontinuation of study drug; Treatment-emergent serious adverse events (SAEs); Proportion of patients with treatment-emergent ALT and/or AST abnormality (> 3, > 5, and > 8 x ULN) associated or not with total bilirubin > 2 x ULN.; Proportion of patients with treatment-emergent hemoglobin abnormality (? 100 g/L, and ? 80 g/L)	Baseline to end of treatment visit (around 6 months on average)

External Links

•   Extension of the psychometric validation study ORCHESTRA in patients with PAH