Trial · NCT03850964
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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 |
| Other | Change with pazopanib treatment for epistaxis frequency and speed of flow, and fatigue | Baseline, 12, 24, and 48 weeks | Meaningful change quantities will be determined using domain-specific, patient-reported anchors focusing on importance and severity of change. Focus will be on change from baseline to 12, 24, and 48 weeks |
| Other | Assess effects of up to 24 weeks of pazopanib treatment on epistaxis symptom elements | Baseline, 3-week dosing intervals over study | Change in epistaxis: frequency, speed of flow, and epistaxis duration |
| Other | Assess effect of up to 24 and 48 weeks of pazopanib treatment on level of epistaxis severity | Epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; Change in ESS at 12, 24 and 48 weeks (versus baseline) | * Change in level of epistaxis severity by at least one unit * Change in ESS by time |
| Other | Change or reduction in iron supplementation for up to 48 weeks of treatment | Baseline, Week 19-24, Weeks 43-48 | IV and oral iron use (together and separately) |
| Other | Effects of up to 48 weeks of pazopanib treatment on serum ferritin for all patients | Weeks 0, 12, 24, 36, and 48 | Serum ferritin levels |
| Other | Effects of up to 48 weeks of pazopanib treatment on quality of life | Part B: Baseline, every 6 weeks; Part C: Baseline, every 12 weeks | Changes in social and physical activity PROMIS self-reported questionnaire |
| Other | Perceived benefits of up to 48 weeks of pazopanib treatment for reducing symptoms, specifically satisfaction | Week 24, 48 or early study termination visit | Response to an exit interview at the last visit |
| Other | Effects of up to 48 weeks of pazopanib treatment on cardiac function | Baseline, weeks 24 and 48 | * BNP protein levels in all patients * Echo, 6 min walk, and diuretic usage record in patients with clinical heart failure due to liver AVM |
| Other | Examine the drug mechanism of pazopanib treatment | Baseline, Weeks 24 and 48 | Measure VEGFR2 serum values |
| Other | Examine the role of genotype on response to pazopanib treatment | Weeks 24 and 48 | Epistaxis and hemoglobin outcomes stratified by genotype (Alk1, Endoglin, SMAD) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03850964/registered