Trial · NCT01408030

North American Study of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

NCT01408030, Phase 2, Completed, James Gossage; results first posted 2018-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. North American Study of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT). Trials, record NCT01408030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01408030

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: North American Study of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
NCT number: NCT01408030
Status: Completed
Phases: Phase 2
Enrollment: 123 participants, actual
Lead sponsor: James Gossage
Conditions: Telangiectasia, Hereditary Hemorrhagic, Epistaxis
Interventions: Sterile saline, Bevacizumab, Estriol, Tranexamic Acid
First posted: 2011-08-02
Last updated: 2018-10-19
Results first posted: 2018-10-19
Limitations and caveats: 1\. One key limitation is the lack of a baseline epistaxis diary. 2. Drug absorption may have been hampered because of local scab and crust formation causing a barrier to drug penetration. 3. Saline may not be a true placebo due to hydration effects.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Frequency of Epistaxis	Weeks 5-12 of active treatment phase	Bleeding episodes per week
Secondary	Duration of Epistaxis	5-12 weeks of active treatment	Total minutes of bleeding per week
Secondary	Hoag Epistaxis Severity Score	12 weeks	Hoag Epistaxis Severity Score (ESS) is based on 6 nosebleed variables such as frequency and duration which are entered by patients. The ESS has a minimum value of 0 and maximum value of 10, with 10 representing more severe epistaxis.
Secondary	Hemoglobin Level	12 weeks	grams/100 ml, assessed at week 12
Secondary	Number of Participants Requiring Red Blood Cell (RBC) Transfusion	12 weeks	Number of participants requiring RBC transfusion during weeks 1-12
Secondary	Number of Participants With Treatment Failure	Baseline through 12 weeks	Treatment failure is defined as the occurrence of one or more of the following during the study: need for nasal surgery or chemical cautery or other new treatment modality to control epistaxis; transfusion of more than 12 units of RBC; severe complications such as acute myocardial infarction, venous thromboembolism, brain hemorrhage; or death

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Frequency of Epistaxis	Weeks 5-12 of active treatment phase	Participants were included in this analysis (106) if they had at least 3 weeks of data during weeks 5-12; therefore the number of participants analyzed do not equal the number who finished the active treatment phase (120). 2 patients were lost to follow up, 5 dropped out before week 5, 6 filled out diaries incorrectly, and 1 had no diary.	Bleeding episodes per week	MEDIAN
SECONDARY	Duration of Epistaxis	5-12 weeks of active treatment	Participants were included in this analysis (112) if they had at least 3 weeks of data during weeks 5-12; therefore the number of participants analyzed do not equal the number who finished the active treatment phase (120). 2 patients were lost to follow up, 5 dropped out before week 5, and 1 had no epistaxis diary.	Total minutes of bleeding per week	MEDIAN
SECONDARY	Hoag Epistaxis Severity Score	12 weeks	Participants were included in this analysis if they completed week 12 (phase 1) and filled out an ESS score. 1 participant each from the bevacizumab and placebo group did not fill out an ESS score at week 12.	units on a scale (0-10)	MEDIAN
SECONDARY	Hemoglobin Level	12 weeks	8 participants who finished the active treatment phase did not have a hemoglobin level measured, and thus only 99 were analyzed.	gram/100 ml	MEDIAN
SECONDARY	Number of Participants Requiring Red Blood Cell (RBC) Transfusion	12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment Failure	Baseline through 12 weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Frequency of Epistaxis	Bevacizumab Spray	7.0	Inter-Quartile Range 4.5 to 10.5	Bleeding episodes per week
Frequency of Epistaxis	Estriol Spray	8.0	Inter-Quartile Range 4.0 to 12.0	Bleeding episodes per week
Frequency of Epistaxis	Tranexamic Acid Spray	7.5	Inter-Quartile Range 3.0 to 11.0	Bleeding episodes per week
Frequency of Epistaxis	Placebo Spray	8.0	Inter-Quartile Range 3.0 to 14.0	Bleeding episodes per week
Duration of Epistaxis	Bevacizumab Spray	23.5	Inter-Quartile Range 13 to 40	Total minutes of bleeding per week
Duration of Epistaxis	Estriol Spray	36.5	Inter-Quartile Range 7 to 70	Total minutes of bleeding per week
Duration of Epistaxis	Tranexamic Acid Spray	44.5	Inter-Quartile Range 13.5 to 87.5	Total minutes of bleeding per week
Duration of Epistaxis	Placebo Spray	46	Inter-Quartile Range 10 to 84	Total minutes of bleeding per week
Hoag Epistaxis Severity Score	Bevacizumab Spray	3.54	95% Confidence Interval 3 to 4.08	units on a scale (0-10)
Hoag Epistaxis Severity Score	Estriol Spray	3.56	95% Confidence Interval 2.81 to 4.3	units on a scale (0-10)

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Phase (on Drug)	STARTED	Bevacizumab Spray	29
Treatment Phase (on Drug)	STARTED	Estriol Spray	31
Treatment Phase (on Drug)	STARTED	Tranexamic Acid Spray	33
Treatment Phase (on Drug)	STARTED	Placebo Spray	28
Treatment Phase (on Drug)	COMPLETED	Bevacizumab Spray	26
Treatment Phase (on Drug)	COMPLETED	Estriol Spray	24
Treatment Phase (on Drug)	COMPLETED	Tranexamic Acid Spray	32
Treatment Phase (on Drug)	COMPLETED	Placebo Spray	25
Treatment Phase (on Drug)	NOT COMPLETED	Bevacizumab Spray	3
Treatment Phase (on Drug)	NOT COMPLETED	Estriol Spray	7

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasal symptoms	Respiratory, thoracic and mediastinal disorders	Bevacizumab Spray	11	29	11
other	Nasal symptoms	Respiratory, thoracic and mediastinal disorders	Estriol Spray	12	30	12
other	Nasal symptoms	Respiratory, thoracic and mediastinal disorders	Tranexamic Acid Spray	10	33	10
other	Nasal symptoms	Respiratory, thoracic and mediastinal disorders	Placebo Spray	10	28	10
other	Headache	Nervous system disorders	Bevacizumab Spray	10	29	10
other	Headache	Nervous system disorders	Estriol Spray	12	30	12
other	Headache	Nervous system disorders	Tranexamic Acid Spray	10	33	10
other	Headache	Nervous system disorders	Placebo Spray	6	28	6
other	Nausea/vomiting	Gastrointestinal disorders	Bevacizumab Spray	4	29	4
other	Nausea/vomiting	Gastrointestinal disorders	Estriol Spray	1	30	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bevacizumab Spray	0	29
Total, all-cause mortality	Estriol Spray	0	30
Total, all-cause mortality	Tranexamic Acid Spray	0	33
Total, all-cause mortality	Placebo Spray	0	28
Total, other adverse events	Bevacizumab Spray	24	29
Total, other adverse events	Estriol Spray	25	30
Total, other adverse events	Tranexamic Acid Spray	26	33
Total, other adverse events	Placebo Spray	23	28
Total, serious adverse events	Bevacizumab Spray	0	29
Total, serious adverse events	Estriol Spray	0	30

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27599329	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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