ACTIVE_NOT_RECRUITING

A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

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Conditions

Hereditary AngioedemaHAEAngioedemaLong-termSafety

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.

Official Title

A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients With Hereditary Angioedema (The ALPHA-SOLAR Trial)

Quick Facts

Study Start:2023-09-26
Study Completion:2031-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06007677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
  2. * Completed STAR-0215-201 (follow up through 6 months after their last dose);
  3. * Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
  4. * Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
  5. * Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor).
  6. * Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).
  1. * 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.
  2. * Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening
  3. * Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
  4. * Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
  5. * lanadelumab within 90 days
  6. * berotralstat within 21 days
  7. * all other prophylactic therapies, discuss with the Medical Monitor

Contacts and Locations

Study Locations (Sites)

Allervie Clinical Research
Birmingham, Alabama, 35209
United States
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona, 85251
United States
Acuro Research
Little Rock, Arkansas, 72205
United States
UC San Diego US HAEA Angioedema Center
San Diego, California, 92122
United States
Raffi Tachdjian MD, Inc
Santa Monica, California, 90404
United States
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598
United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, 20815
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Optimed Research
Columbus, Ohio, 43235
United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
AARA Research Center
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: Astria Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-26
Study Completion Date2031-03

Study Record Updates

Study Start Date2023-09-26
Study Completion Date2031-03

Terms related to this study

Keywords Provided by Researchers

  • HAE
  • Angioedema
  • Long-term
  • Safety

Additional Relevant MeSH Terms

  • Hereditary Angioedema