Phase 4
N=40
Intranasal Bevacizumab for HHT-Related Epistaxis
HHT · Hereditary Hemorrhagic Telangiectasia · Epistaxis · Nose Bleeds · Nasal Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT02389959 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Change in Epistaxis Severity Score (ESS) — -2.27; -1.16; -2.27; -1.01 score on a scale — p=0.111
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bevacizumab (Drug); Placebo (Saline) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Epistaxis Severity Score (ESS) |
-2.27; -1.16; -2.27; -1.01; -2.00; -1.16 | 0.111 |
| SECONDARY Short Form-12 (SF-12) Physical Component Summary (PCS) Score |
40.53; 40.43; 39.71; 40.88; 39.96; 40.71 | 0.191 |
| SECONDARY Short Form-12 (SF-12) Mental Component Summary (MCS) Score |
51.76; 54.22; 54.48; 50.96; 51.09; 53.61 | 0.366 |
| SECONDARY Reduction in Epistaxis-related Costs (Direct and Indirect) |
74; 16; 9; 11; 11; 0 | 0.030 sig |
Summary
This is a randomized, controlled, double-blind, placebo-controlled trial of intranasal Avastin (bevacizumab) injection versus saline control for control of HHT-related epistaxis when used in conjunction with bipolar electrocautery.
Eligibility Criteria
Inclusion Criteria
- The patient carries a diagnosis of hereditary hemorrhagic telangiectasia (HHT)
- The patient is to undergo treatment with electrocautery in the operating room under endoscopic visualization
- The patient is able to give informed consent
- The patient is at least 18 years old
Exclusion Criteria
- The patient has had prior treatment with systemic or nasal bevacizumab within the past year
- The patient has undergone electrocautery for epistaxis within the 6 months prior to study enrollment
- The patient is a minor
- The patient is pregnant
- The patient is incapable of understanding the consent process
- The patient has a history of HIV or another known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.
Data sourced from ClinicalTrials.gov (NCT02389959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.