Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07863609

Phase 1b Study of TX002100 in Participants With Hematologic Support-Dependent Hereditary Hemorrhagic Telangiectasia (HHT)

Conditions: Hereditary Hemorrhagic Telangiectasia (HHT)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: Tectonic Operating Company, Inc.

Summary

The primary purpose of this study is to assess the safety and tolerability of TX002100 in participants with hereditary hemorrhagic telangiectasia (HHT). The study will also look at whether TX002100 reduces the need for blood or iron treatments, and whether it improves blood counts, such as hemoglobin levels.

Eligibility Criteria

Inclusion Criteria: 1. Adults with HHT who need regular intravenous iron or blood transfusions. 2. Females of childbearing potential and male participants must agree to comply with the contraception requirements. 3. Able to understand and is willing and able to comply with the study requirements and study procedures and agrees to participate in the study by giving written informed consent. Exclusion Criteria: 1. History of anemia of any cause other than HHT-related bleeding, or any other clinically significant inherited bleeding disorder aside from HHT. 2. Has undergone or is anticipated to undergo liver transplantation. 3. Medical conditions or comorbidities that, in the opinion of the investigator, would interfere with study compliance or data interpretation; or, in the opinion of the Investigator, taking part in the study would jeopardize the safety of the patient. 4. History of hemorrhage from untreated pulmonary arteriovenous malformations (AVMs) manifesting as hemoptysis or hemothorax within 12 weeks before screening. 5. Receipt of any vaccination within 2 weeks prior to first dose. 6. Recent major surgery (within 4 weeks before the screening visit) or planned major surgery during the study. 7. GI bleeding due to non-HHT disease (e.g., GI ulcers, diverticulosis), in the opinion of the investigator, within 6 months before screening.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07863609). StuddyBuddy aggregates publicly available trial information.