Trial · NCT03850964
Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz)
NCT03850964, Phase 2, Phase 3, Completed, Cure HHT
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz). Trials, record NCT03850964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03850964
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz)
- NCT number
- NCT03850964
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 71 participants, actual
- Lead sponsor
- Cure HHT
- Conditions
- Hereditary Hemorrhagic Telangiectasia, Epistaxis, Anemia, Nosebleed, HHT
- Interventions
- Pazopanib, Placebo oral capsule
- First posted
- 2019-02-22
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in epistaxis duration in minutes | Average duration in weeks 19-24 (last 6 weeks of blinded phase) versus baseline. | \>=50% decrease in the duration of epistaxis in the 150 mg pazopanib arm versus the placebo arm (moderate and severe cohorts combined) |
| Primary | Hemoglobin Response rate increase in hemoglobin | Average duration in weeks 19-24 (last 6 weeks of blinded phase) versus baseline. | Increase in hemoglobin by ≥ 2 g/dl in the 150 mg pazopanib arm versus the placebo arm (moderate and severe cohorts combined) |
| Secondary | Achievement of meaningful improvement in epistaxis for HHT patients | Baseline [screening, run-in and 0 time points] and week 24. | Compare patients reported being bothered by epistaxis at baseline and report not bothered at week 24 |
| Secondary | Percent change in blood transfusion rate in the Severe Cohort | Baseline, and weeks 13-24 | Reduction in RBC transfusion rate by at least one unit |
| Secondary | Assess the safety of up to 24 and 48 weeks of treatment of pazopanib | 1st dose of intervention until Weeks 24 and 48 | * AEs; absolute values and changes over time of hematology, clinical chemistry, urinalysis, blood pressure, and heart rate. * Physical exam, leg and abdominal evaluations, and CNS symptoms. * ECG parameters (PR, QRS, QT, QTc intervals) in addition to cardiac echocardiogram to evaluate LV function from pre-dose values in at-risk patients (baseline EF \<50) |
| Secondary | Assess pharmacokinetics and pharmacodynamics (PK/PD) of treatment | Weeks 12, 24, 36 and 48 | * Cτ, data permitting * Graphical exploration of PK/PD relationships between pazopanib and selected PD endpoints |
| Secondary | Establish comparability of endpoint outcomes for each hemoglobin stratification | Baseline, Weeks 19-24, Week 48 | Trends for primary endpoint in severe (hemoglobin (\<9.5 g/dl) and moderate (9.5-10.9 g/dl) groups. |
| Other | Assess effects of up to 24 weeks of pazopanib treatment on epistaxis duration | Baseline and weeks 19-24 of study. | Decrease in Epistaxis duration by ≥50% averaged over weeks 19-24 versus baseline |
| Other | Assess the effects of up to 24 weeks of pazopanib treatment on hemoglobin levels | Baseline and weeks 19-24 of study | Increase in hemoglobin over the 24 weeks by 2g/dL of greater average over weeks 19-24 versus baseline (overall and stratified by hemoglobin) |
| Other | Assess the effects of up to 24 weeks of pazopanib treatment on frequency of nose bleeds and speed of flow | Baseline and weeks 19-24 of study | Establish percentage decrease in frequency of nose bleeds and speed of flow category improvement averaged over weeks 19-24 versus baseline |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD006840 | A Phase II/III randomized, placebo controlled, double blind study to evaluate the effects of up to 24 weeks of low dose pazopanib on HHT related epistaxis and anemia. IND#144808 June 25, 2020 | GOSSAGE, JAMES RICHARD | HHT FOUNDATION INTERNATIONAL, INC. | FOOD AND DRUG ADMINISTRATION | 2022 to 2025 |
Source NIH RePORTER
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03850964
GET https://conductscience.org/api/trials/v1/NCT03850964/registered