Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (T… (NCT05128929) | Clinical Trial Compass
CompletedPhase 2
Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).
United States17 participantsStarted 2022-04-01
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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:
✓. 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:
✕. Total Lung Capacity (TLC) less than 60% predicted
What they're measuring
1
Calculated Pulmonary Vascular Resistance (PVR)
Timeframe: Baseline to end of treatment (Week 24; +/- 7 days)