STAR-0215 for Hereditary Angioedema

Phase 2

Recruiting

Research Sponsored by Astria Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria

Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months for first 2 years, every 6 months for next 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a drug for long-term safety and effectiveness in treating hereditary angioedema (HAE). Patients will take the drug over 5 years.

Who is the study for?

This trial is for people with hereditary angioedema who participated in a previous STAR-0215 study and met certain conditions. They shouldn't have used ACE inhibitors, estrogen medications, or androgens recently, nor should they have other chronic angioedema types or be on preventive HAE therapies without consulting the medical monitor.

What is being tested?

The trial tests the long-term safety and effectiveness of repeated doses of STAR-0215 in individuals with hereditary angioedema. It's designed to last up to five years, gathering extensive data on how well this treatment works over time.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term use of STAR-0215. This may include new or worsening symptoms related to their condition or unexpected health issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a chronic form of angioedema other than hereditary.

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I have not taken any androgen medications in the last 7 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 months for first 2 years, every 6 months for next 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 months for first 2 years, every 6 months for next 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for first 2 years, every 6 months for next 3 years for reporting.