Last updated on August 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vascular Diseases | Pulmonary Arterial Hypertension | Cardiovascular Disease | Effects of Chemotherapy | Cancer Prevention | Indikation: Diabetes - Typ II | Low Testosterone | Infantile Fibrosarcoma | Nerve Injury | CONNECTIVE TISSUE DISEASE | Cancer Treatment | Chronic Renal Anemia | High Blood Pressure (Hypertension) | Pulmonary Disease | Chronic Pelvic Pain | Spinocerebellar Disorders | Diabetes and Hypertension | Connective Tissue Diseases | Stasis Dermatitis | Pelvic Adhesions | Serial Evaluation of Ductal Epithelium | Testotoxikose | Pseudobulbar Affect | High Blood Pressure (Hypertension - Pediatric) | Dental Filling | Abdominal Surgery | Memory Problems | Gambling Problems | Surviving Abuse | Partial Medial Meniscectomy | Familial Primary Pulmonary Hypertension | Primary Insulin Hypersecretion | Severe Premenstrual Symptom | Habit Reversal | Renal Anemia | polycyclic aromatic hydrocarbons | Late Infantile Neuronal Ceroid Lipfuscinsosis | Functional Dyspepsia | Dermatomyositis (Connective Tissue Disease) | Lung Disease | Pulmonary Hypertension | Spine Athroplasty | Respiratory Tract Diseases | Hypertension | Open Heart Surgery | Mental Disability | Recurrent Pregnancy Loss | Complicated Grief | Anemic Cancer | Joint Injuries | Myopic Macular Degeneration | Catheter Complications
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. At least 18 years of age.
  2. 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.
  3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  4. Primary diagnosis of symptomatic PAH
  5. 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
  6. Has WHO/ NYHA functional class II to IV symptoms.
  7. 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.
  8. Has a 6MWD of 150 meters.

Exclusion Criteria:

  1. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline.
  2. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol.
  3. Has evidence of more than mild lung disease on PFTs performed within 180 days prior to, or during Screening.
  4. 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.
  5. Current diagnosis of uncontrolled sleep apnea as defined by the Investigator.
  6. 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.
  7. Severe chronic liver disease (ie, Child-Pugh C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy).
  8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  9. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of normal (ULN) or total bilirubin 2 ULN at Screening.
  10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening.
  11. Hemoglobin concentration <9 g/dL at Screening.
  12. 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).
  13. Subjects treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) that was stopped for a safety or tolerability issue.
  14. Subject has pulmonary veno-occlusive disease.
  15. 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.
  16. 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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