A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

  • STATUS
    Recruiting
  • End date
    Dec 12, 2022
  • participants needed
    700
  • sponsor
    United Therapeutics
Updated on 13 June 2021
hypertension
pulmonary arterial hypertension
right heart catheterization
endothelin
ralinepag
endothelin receptor antagonist

Summary

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Description

Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study (after the target number of events is achieved) will have the option to enroll in an open-label extension (OLE) study.

Details
Condition Pulmonary Disease, Vascular Diseases, CONNECTIVE TISSUE DISEASE, Respiratory Tract Diseases, Hypertension, Pulmonary Hypertension, Cardiovascular Disease, polycyclic aromatic hydrocarbons, Cancer Prevention, Surviving Abuse, Joint Injuries, Abdominal Surgery, Mental Disability, Pelvic Adhesions, Low Testosterone, Dental Filling, Habit Reversal, Complicated Grief, Diabetes and Hypertension, Chronic Pelvic Pain, Gambling Problems, Myopic Macular Degeneration, Nerve Injury, Severe Premenstrual Symptom, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Dermatomyositis (Connective Tissue Disease), Stasis Dermatitis, Pulmonary Arterial Hypertension, Open Heart Surgery, Recurrent Pregnancy Loss, Effects of Chemotherapy, Renal Anemia, Functional Dyspepsia, Catheter Complications, Serial Evaluation of Ductal Epithelium, Chronic Renal Anemia, Cancer Treatment, Anemic Cancer, Spinocerebellar Disorders, Pseudobulbar Affect, Spine Athroplasty, Indikation: Diabetes - Typ II, Partial Medial Meniscectomy, Primary Insulin Hypersecretion, Testotoxikose, Infantile Fibrosarcoma, Late Infantile Neuronal Ceroid Lipfuscinsosis, Elevated Blood Pressure, Familial Primary Pulmonary Hypertension, Connective Tissue Diseases, Lung Disease, Memory Problems, vascular disorder, connective tissue disorder, p-aminohippuric acid, hpah, high blood pressure, arterial hypertension, pulmonary diseases, lung diseases, pulmonary disorders, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders, vascular disease, vasculopathy, vasc, respiratory tract disease
Treatment Placebo, Placebo tablet, Ralinepag Tablet, Extended Release, Ralinepag
Clinical Study IdentifierNCT03626688
SponsorUnited Therapeutics
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years of age
Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Primary diagnosis of symptomatic PAH
Has had a right heart catheterization (RHC) performed at or within 3 years of Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH
Has WHO/ NYHA functional class II to IV symptoms
If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be nave to PAH-specific treatment
Has a 6MWD of 150 meters

Exclusion Criteria

For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline
Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol
Has evidence of more than mild lung disease on PFTs performed within 180 days prior to, or during Screening
Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH
Current diagnosis of uncontrolled sleep apnea as defined by the Investigator
Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG measured at Screening or Baseline in subjects without evidence of intraventricular conduction delay (IVCD). In the presence of IVCD, subjects will be excluded if the QTcF >500 msec for both males and females
Severe chronic liver disease (ie, Child-Pugh C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy)
Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of normal (ULN) or total bilirubin 2 ULN at Screening
Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening
Hemoglobin concentration <9 g/dL at Screening
Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) at any time prior to Baseline (use in vasoreactive testing is permitted)
Subjects treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) that was stopped for a safety or tolerability issue
Subject has pulmonary veno-occlusive disease
Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent
Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse
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