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

Phase 2
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of treatment (week 24)

Summary

This trial is testing an oral drug called Hymecromone in adults with pulmonary hypertension. The goal is to see if it can safely improve lung function and reduce blood pressure in the lungs over several months.

Eligible Conditions
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment (week 24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment (week 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pulmonary Vascular Resistance (PVR)
Secondary study objectives
6 Minute Walk Distance Test (6 MWDT)
Change in Mean Pulmonary Arterial Pressure (mPAP)
N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
+3 more
Other study objectives
Exhaled breath condensate (EBC) hyaluronan concentrations
Forced Expiratory Volume in one second (FEV1)
Forced Vital Capacity (FVC) from Pulmonary Function Test (PFT)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Treatment Oral Hymecromone (H01)Experimental Treatment1 Intervention
Treatment will be initiated. Participants will be administered 800 mg of oral H01 two times a day (total dose: 1600 mg/day). Participants will continue to be on treatment for 24 weeks and will be monitored with assessments.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to placebo will receive oral tablet placebo (inactive ingredients) two times a day. Participants will continue to be on placebo for 24 weeks and will be monitored with assessments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hymecromone (H01)
2022
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,516,105 Total Patients Enrolled

Media Library

Hymecromone (H01) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05128929 — Phase 2
Pulmonary Hypertension Research Study Groups: Experimental Treatment Oral Hymecromone (H01), Placebo
Pulmonary Hypertension Clinical Trial 2023: Hymecromone (H01) Highlights & Side Effects. Trial Name: NCT05128929 — Phase 2
Hymecromone (H01) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128929 — Phase 2
~4 spots leftby Dec 2025
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