![]() ![]() Subjects can consent to participate in all, part, or none of these analyses, and subjects who do not wish to participate may still participate in the main clinical study.Įach subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:Ģ. Comparing treatment responses and treatment-related change to these parameters may reveal important information with regard to: 1) the pathophysiology and natural history of PAH, 2) treatment response and effect of treatment on proteomics, and 3) ralinepag mechanism of action. Optional evaluation of proteomics, metabolomics, transcriptomics, and genetics:įor subjects who agree to participate in the optional proteomics, metabolomics, and transcriptomics analyses, blood samples will be collected at Baseline, the Week 28 Visit, and the Study Drug Termination Visit for subjects who agree to participate in the optional genetic analysis, a blood sample will be collected at Baseline. Heart rate recovery (HRR) following completion of the 6-minute walkĢ) To evaluate the time to all-cause hospitalizationģ) To evaluate the time to all-cause mortalityĤ) To evaluate the safety and tolerability of ralinepag in subjects withįull title, date and version of each sub-study and their related objectives.Health-related quality of life (HRQoL) measures.Shift and proportion of subjects who attain all three of the following:.WHO/ New York Heart Association (NYHA) functional class.N-terminal pro b-type natriuretic peptide (NT-proBNP).The secondary objectives of the study are:ġ) To evaluate the effects of ralinepag from Baseline to Week 28 on: To demonstrate the effect of ralinepag on the time to first adjudicated protocol-defined clinical worsening event in subjects with PAH. ![]() Pulmonary hypertension WHO functional class IĬondition being studied is a rare disease Medical condition in easily understood languageĭiseases - Cardiovascular Diseases Į.1.2 Medical condition or disease under investigation Medicinal product containing genetically modified organismsĮ.1 Medical condition or disease under investigation Immunological medicinal product (such as vaccine, allergen, immune serum) one involving a medical device)Ĭommittee on Advanced therapies (CAT) has issued a classification for this productĬombination product that includes a device, but does not involve an Advanced Therapy The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)Īctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e. IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old. Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). Allows you to search for protocol and results information on:
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