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Seralutinib for Pulmonary Arterial Hypertension

Phase 3

Recruiting

Research Sponsored by GB002, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will assess the safety, side effects, and effectiveness of inhaled seralutinib over a long period of time in participants who have already finished a previous seralutinib study

Who is the study for?

This trial is for adults who have completed a previous study with seralutinib and are living with Pulmonary Arterial Hypertension (PAH), a type of high blood pressure that affects the arteries in the lungs. Specific eligibility details aren't provided, but typically participants must meet certain health standards.

What is being tested?

The trial is testing the long-term safety and effectiveness of an orally inhaled drug called seralutinib, using a device known as Gereic Dry Powder Inhaler. It's an open-label extension, meaning everyone knows they're getting seralutinib and not a placebo.

What are the potential side effects?

While specific side effects are not listed here, common ones for PAH medications can include cough, headache, dizziness, nausea, fatigue or irritation at the inhalation site. Long-term effects will be particularly monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man who will use a condom if I have sex with a woman who can get pregnant, from now until 90 days after my last treatment dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) for reporting.