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NCT04404881 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab In Hereditary Hemorrhagic Telangiectasia
A Phase 2 study of Hereditary Hemorrhagic Telangiectasia, sponsored by Hanny Al-Samkari, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT04404881: Active Phase 2 study of Hereditary Hemorrhagic Telangiectasia, sponsored by Hanny Al-Samkari, MD.
NCT04404881 is a Phase 2 study of Hereditary Hemorrhagic Telangiectasia that is active but no longer recruiting, run by Hanny Al-Samkari, MD. The registered enrollment target is 33 participants, below the 1,786-participant average among 7 other Hereditary Hemorrhagic Telangiectasia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04404881, a Phase 2 study of Hereditary Hemorrhagic Telangiectasia, is active but no longer recruiting, sponsored by Hanny Al-Samkari, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is studying to see whether bevacizumab may treat chronic bleeding and iron deficiency anemia in Hereditary Hemorrhagic Telangiectasia (HHT). Hereditary Hemorrhagic Telangiectasia (HHT) is a disorder that causes abnormal blood vessel formation. In HHT, there is a mutation in the TGF-β pathway, which results in an increase of vascular endothelial growth factor (VEGF) levels. An increase in VEGF levels can result in poorly formed blood vessels that have a higher rate of bleeding than normal blood vessels. Bevacizumab is designed to block VEGF activity. It is believed that targeting increased VEGF levels may be able to treat HHT. This research study involves the following study drug: \- Bevacizumab
Primary Outcome
The change in Hematologic Support Score (HSS) from pretreatment to maintenance will be evaluated with a paired t-test or a Wilcoxon signed-rank test, whichever is most appropriate for the distribution of the data. Presence of a statistically-significant difference (P\<0.05) will determine if the study achieves its primary outcome measure.
Conditions Studied
Interventions
- DRUG Bevacizumab (Avastin®)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 2 |
What the registry record for NCT04404881 still lists
NCT04404881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,786-participant average among 7 other Hereditary Hemorrhagic Telangiectasia trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Hereditary Hemorrhagic Telangiectasia appearing as the primary indexed condition, and to 1 intervention - of which Bevacizumab (Avastin®) is the first listed.
NCT04404881 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04404881 about?
NCT04404881 is a clinical study titled "Bevacizumab In Hereditary Hemorrhagic Telangiectasia". This research study is studying to see whether bevacizumab may treat chronic bleeding and iron deficiency anemia in Hereditary Hemorrhagic Telangiectasia (HHT). Hereditary Hemorrhagic Telangiectasia (HHT) is a disorder that causes abnormal blood vessel formation. In HHT, there is a mutation in the ...
What is the current status of trial NCT04404881?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2020-11-23. Estimated completion is 2027-02-01.
What conditions does trial NCT04404881 study?
This clinical trial studies the following conditions: Hereditary Hemorrhagic Telangiectasia.
What interventions are being tested in trial NCT04404881?
The interventions under investigation include: Bevacizumab (Avastin®) (DRUG).
Who is sponsoring clinical trial NCT04404881?
This trial is sponsored by Hanny Al-Samkari, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04404881 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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