An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

• Conditions: subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH); MedDRA version: 14.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-001642-17-AT
• Lead Sponsor: GlaxoSmithKline Research & Developement Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-04
• Last Update Posted: 1 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:
Have been randomized to the protocol for AMB115811 and have met one of the following:
a) Completed the Week 16 visit in AMB115811;
b) Prematurely withdrew from AMB115811 for whatever reason*
*where IP has been stopped due to safety or efficacy reasons, the subject may still
enter into the open label study regardless of what treatment they are receiving (other treatments will not be supplied by the sponsor) but will not be permitted to receive IP.
Subject is able and willing to give written informed consent. As part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study
treatment that may impact subject eligibility is provided in the Investigators Brochure and product label for PAH indication.
Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore,
adherence to the criteria as specified in the protocol is essential.

French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Exclusion from IP
Subjects meeting any of the following criteria must not receive ambrisentan, however may still be followed-up as part of the study and be treated according to best clinical practice as decided by the investigator:
1. Subject has a known hypersensitivity to the Investigational Products, the metabolites, or formulation excipients
2. Female subjects who are pregnant or breastfeeding or no-longer agree to comply with using effective contraception as defined in Appendix 2
3. Subjects with ALT and/or AST = 3xULN
4. Subjects with bilirubin = 2xULN (>35% direct bilirubin)
5. Subjects with severe renal impairment (estimated creatinine clearance <30 mL/min assessed within the previous 45 days) at the point of transition from Study AMB115811
6. Subject has moderate - severe hepatic impairment (Child-Pugh class B-C with or without cirrhosis) at the point of transition from study AMB115811
7. Subject with clinically significant fluid retention in the opinion of the investigator
8. Subject with clinically significant anemia in the opinion of the investigator
9. Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB115811.

Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified