Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

Phase 3

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Macitentan

• Registration Number: NCT02112487
• Lead Sponsor: Actelion

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Study Start: 2014-06-23
• Primary Completion: 2018-09-19
• Study Completion: 2018-09-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Macitentan	Macitentan	10 mg once daily

Primary Outcome Measures

Name	Time	Method
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.	Baseline to end of treatment visit (around 6 months on average)	* 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)

Trial Locations

Locations (32)

Hospital General de Alicante; 🇪🇸 Alicante, Spain

Hospital Val Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinic; 🇪🇸 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, Spain

Hôpital Côte de Nacre; 🇫🇷 Caen, France

Hôpital de Haut Levêque; 🇫🇷 Pessac, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

A.O.U.C. Careggi; 🇮🇹 Firenze, Italy

Hôpital Louis Pradel; 🇫🇷 Bron Cedex, France

Hôpital Albert Michallon; 🇫🇷 Grenoble, France

CHU de Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

CHRU Lille - Hôpital Cardiologique; 🇫🇷 Lille, France

UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica; 🇮🇹 Rome, Italy

Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Hôpitaux de Brabois; 🇫🇷 Nancy, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Hôpital Civil; 🇫🇷 Strasbourg, France

Hôpital Larrey; 🇫🇷 Toulouse, France

Hôpital Nord; 🇫🇷 Saint-Etienne, France

Ospedale Sant'Orsola; 🇮🇹 Bologna, Italy

Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare; 🇮🇹 Rome, Italy

Policlinico G.B. Rossi; 🇮🇹 Verona, Italy