Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study). (SATURN)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    16
  • sponsor
    Stanford University
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Updated on 5 June 2022
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prostaglandin
right heart catheterization
endothelin
endothelin receptor antagonist

Summary

This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks.

Study Hypothesis:

Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks

Description

The study's objectives are to evaluate:

  • The changes in clinical and functional measures (pulmonary function test, pulmonary vascular resistance, mean pulmonary arterial pressure, and 6 Minute Walk Distance Test) in adults with PH treated with oral H01
  • The safety and tolerability of the use of oral H01 for PH over 24 weeks using health criteria/evaluations (Common Terminology Criteria for Adverse Events (CTCAE), quality of life (QOL) score, EMPHASIS-19 score and St George Respiratory Questionnaire (SGRQ) score)
  • To investigate the clinical efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) markers (serum HA concentration, inflammatory markers and cytokines, NT-proBNP, and H01 and metabolite serum concentrations) in this population following oral H01 use

Details
Condition Pulmonary Hypertension
Treatment Placebo, Hymecromone (H01)
Clinical Study IdentifierNCT05128929
SponsorStanford University
Last Modified on5 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Classified as WHO functional class II/III/IV despite treatment with maximally tolerated doses of 2 or more treatment modalities (exp. PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids)
Baseline 6MWT: greater than 100 meters and less than 550 meters
Established diagnosis of Group 3 pulmonary hypertension as a result of interstitial lung disease OR established diagnosis of Group 1 pulmonary hypertension as a result of connective tissue disease, idiopathic, hereditary, drugs, or toxins
Right heart catheterization at randomization showing pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg and PVR > 400 dynes sec cm^ -5) and
PCWP <20 mmHg for Group 3 PH patients and a PCWP <15 for Group 1 PAH patients
Participants on chronic medication for PAH, PH, or underlying lung disease must be on
a stable and optimized dose for at least 90 days prior to the first dose of
the study drug
Female participants who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive
Be able to provide written informed consent and comply with study requirements
Be able to read, speak and understand English

Exclusion Criteria

Participants with a diagnosis of PAH or PH for reasons due to any of the following
Group 2, 4, or 5
Group 1 due to HIV, veno-occlusive disease, porto-pulmonary hypertension, congenital heart disease
Group 3 due to severe chronic obstructive pulmonary disease (COPD) or obstructive sleep apnea (OSA)
Note: participants with overlapping syndromes will be evaluated on a case-by-case basis by the recruiting physician
Total Lung Capacity (TLC) less than 60% predicted
FEV1/FVC less than 50% predicted or FEV1 less than 55% predicted
Inability to safely attempt completion of the 6MWD test
Use of experimental PAH treatments within the past 3 months
Current systemic treatment with hymecromone
Left sided heart disease as defined by either a PCWP greater than 20 mmHg and/or left ventricular ejection fraction less than 40%
Note: participants with abnormal left ventricular function attributable entirely to impaired left ventricular filling due to the effects of right ventricular overload (ie right ventricular hypertrophy and/or dilatation) are not excluded
Participants must not have 3 or more of the following left ventricular disease
dysfunction risk factors
Body mass index (BMI) greater than 30kg/m2
History of essential hypertension requiring medication
Diabetes mellitus
Historical evidence of significant coronary disease established by any of the
following
History of myocardial infarction
History of percutaneous coronary intervention or coronary artery bypass graft
Angiographic evidence of greater than 50% stenosis in at least one coronary artery
Positive stress test with imaging
Stable angina
Significant valvular heart disease as determined by more than moderate findings on
echocardiogram or history of valve replacement
Pregnant or actively breastfeeding
Female participants with childbearing potential not willing to use a form of birth control (including abstinence) during the study
Inability to undergo right heart catheterization
Acute pulmonary embolism within 90 days of randomization
Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of randomizations
Use of any inhaled tobacco products or significant history of drug abuse within 3 months prior to randomization
Subject is receiving greater than 10L/min of oxygen supplementation by any mode of delivery at rest at baseline
Body mass index greater than 40kg/m2
Participants with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
Participants with liver failure or AST or ALT greater than 2 times the upper limit of normal
Participants with total bilirubin levels greater than 2 times the upper limit of normal
Participants with CrCl less than 45
Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization
Known allergy to hymecromone or any component thereof
Known allergy to any component of placebo (including wheat allergy, celiac disease, rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
Physician concern that participant may not adhere to the study protocol
Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent
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