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NCT07667413 · ClinicalTrials.gov registry record · Phase 1
Topical TOR-582 Treatment of Epistaxis in HHT
A Phase 1 study, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT07667413: Recruiting Phase 1 study, sponsored by Columbia University.
NCT07667413 is a Phase 1 study that is actively recruiting participants, run by Columbia University. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07667413, a Phase 1 study, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
People with hereditary hemorrhagic telangiectasia (HHT) often experience frequent and severe nosebleeds that can disrupt daily life and lead to anemia, medical procedures, and reduced quality of life. This study is testing a new nasal ointment called TOR-582, which contains sirolimus, to determine whether it can be used safely when applied inside the nose. Adults with HHT and frequent nosebleeds will be invited to participate. Participants will first complete one week of observation without treatment, followed by up to 12 weeks of applying the study ointment inside each nostril twice daily. Different participants will receive different strengths of the ointment so researchers can identify the safest dose. During the study, participants will attend study visits, complete questionnaires about their nosebleeds and quality of life, keep a daily nosebleed diary, undergo nasal examinations, and have blood tests to monitor safety and medication levels. The information gained from this study will help determine whether this topical treatment can be safely studied further and will support the development of a new, less invasive option for managing nosebleeds in people with HHT.
Primary Outcome
The occurrence of protocol-defined DLTs during the active treatment at each dose level, used to guide escalation/de-escalation decisions and determine the recommended Phase 1b dose. A DLT is defined as the occurrence of Grade 2 or higher AEs in greater than 25% of participants at a given dose level, or more than one Grade 3 or higher AE at any point in the trial.
Interventions
- DRUG Topical sirolimus ointment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2026-07 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT07667413 shows while recruiting
NCT07667413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Topical sirolimus ointment is the first listed.
NCT07667413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07667413 about?
NCT07667413 is a clinical study titled "Topical TOR-582 Treatment of Epistaxis in HHT". People with hereditary hemorrhagic telangiectasia (HHT) often experience frequent and severe nosebleeds that can disrupt daily life and lead to anemia, medical procedures, and reduced quality of life. This study is testing a new nasal ointment called TOR-582, which contains sirolimus, to determine w...
What is the current status of trial NCT07667413?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2026-07. Estimated completion is 2027-05.
What interventions are being tested in trial NCT07667413?
The interventions under investigation include: Topical sirolimus ointment (DRUG).
Who is sponsoring clinical trial NCT07667413?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07667413's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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