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Virus Therapy
HS135 for Pulmonary Arterial Hypertension
Phase 1 & 2
Recruiting
Research Sponsored by 35Pharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of WHO PAH Group 1
Body weight between 45 and 120 kg
Must not have
History of restrictive, constrictive or congestive cardiomyopathy
Uncontrolled systemic hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called HS135 to see if it can help adults with a condition called pulmonary arterial hypertension.
Who is the study for?
Adults with Pulmonary Arterial Hypertension (PAH) who are on at least two PAH treatments can join. They must have a specific heart and lung function, weigh between 45-120 kg, and experience symptoms of PAH. Those with certain heart conditions, recent coronary events, uncontrolled high blood pressure or severe lung function impairment cannot participate.
What is being tested?
The trial is testing HS135 to see if it helps adults with Pulmonary Arterial Hypertension. Participants will receive HS135 while continuing their current PAH medications to determine the effectiveness and safety of this new treatment.
What are the potential side effects?
While the specific side effects of HS135 are not listed here, common side effects for PAH treatments may include headache, dizziness, nausea, diarrhea, swelling in ankles or feet and palpitations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pulmonary arterial hypertension.
Select...
My weight is between 45 and 120 kg.
Select...
I have symptoms of pulmonary arterial hypertension classified between mild to severe.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of heart muscle disease.
Select...
My high blood pressure is not under control.
Select...
I have had a procedure to create a hole in the wall between the upper chambers of my heart.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Physical Examination
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: HS135Experimental Treatment1 Intervention
Subcutaneous Injection
Find a Location
Who is running the clinical trial?
35Pharma IncLead Sponsor
2 Previous Clinical Trials
94 Total Patients Enrolled
Monique Champagne, M.Sc.Study DirectorVP Clinical Operations
1 Previous Clinical Trials
64 Total Patients Enrolled