Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

Sponsor

Actelion (Industry)

Overall Status

Completed

CT.gov ID

NCT02112487

Collaborator

(none)

Enrollment

Locations

Arm

50.9

Actual Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Macitentan	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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™

Actual Study Start Date :

Jun 23, 2014

Actual Primary Completion Date :

Sep 19, 2018

Actual Study Completion Date :

Sep 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Macitentan 10 mg once daily	Drug: Macitentan 10 mg once daily Other Names: ACT-064992

Arm

Intervention/Treatment

Experimental: Macitentan

10 mg once daily

Drug: Macitentan

10 mg once daily

Other Names:

ACT-064992

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure.
Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled
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

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:

Patients who prematurely discontinued study drug in study AC-055-310.
Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.
AST and/or ALT more than 3 X ULN.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Louis Pradel	Bron Cedex	France	69677
2	Hôpital Côte de Nacre	Caen	France	14033
3	Hôpital Albert Michallon	Grenoble	France	38700
4	CHU de Bicêtre	Le Kremlin-Bicêtre	France	94270
5	CHRU Lille - Hôpital Cardiologique	Lille	France	59037
6	Hôpital Arnaud de Villeneuve	Montpellier	France	34295
7	Hôpitaux de Brabois	Nancy	France	54511
8	Hôpital de Haut Levêque	Pessac	France	33604
9	Hôpital Pontchaillou	Rennes	France	35033
10	Hôpital Charles Nicolle	Rouen	France	76031
11	Hôpital Nord	Saint-Etienne	France	42227
12	Hôpital Civil	Strasbourg	France	67091
13	Hôpital Larrey	Toulouse	France	31059
14	Ospedale Sant'Orsola	Bologna	Italy	40138
15	A.O.U.C. Careggi	Firenze	Italy	50124
16	UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica	Rome	Italy	00161
17	Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare	Rome	Italy	00186
18	Policlinico G.B. Rossi	Verona	Italy	37134
19	Hospital General de Alicante	Alicante	Spain	03010
20	Hospital Val Hebron	Barcelona	Spain	08035
21	Hospital Clinic	Barcelona	Spain	08036
22	Hospital de Cruces	Bilbao	Spain	48903
23	Hospital Reina Sofia	Córdoba	Spain	14004
24	Hospital Dr Negrin	Las Palmas de Gran Canaria	Spain	35010
25	Hospital Universitario Insular Gran Canarias	Las Palmas de Gran Canaria	Spain	35016
26	Hospital 12 Octubre	Madrid	Spain	28041
27	Hospital La Paz	Madrid	Spain	28046
28	Hospital Carlos Haya	Malaga	Spain	29010
29	Hospital Son Espases	Palma de Mallorca	Spain	7010
30	Hospital de Valdecilla	Santander	Spain	39008
31	Hospital Virgen del Rocio	Sevilla	Spain	41013
32	Hospita General U. Valencia	Valencia	Spain	46014