Trial · NCT03850730
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change in epistaxis duration in minutes | Summed minutes of bleeding at baseline 3 weeks and the last 3 weeks of dosing, over16-24 weeks of dosing | A daily electronic record of each bleed, with start and end time, provides the daily epistaxis duration, compounded over each 3 weeks of study time |
| Secondary | Percent change in average gushing frequency | Last 3 weeks of drug period vs baseline 3 weeks; over 16-24 weeks of dosing | Patient rated intensity of each bleed, as in 0 or 1, averaged over 3 wk periods. |
| Secondary | Percent change in average bleed frequency | Last 3 weeks compared to the baseline 3 weeks; over 16-24 weeks of dosing | Annotated number of bleeds per day, and summed over 3 week periods |
| Secondary | Absolute [gm/dl] change in serum hemoglobin | comparing last 6 weeks to baseline 3-6 weeks; over 16-24 weeks of drug dosing | Serum values drawn every 3 weeks |
| Secondary | Change in the frequency of blood transfusions | Final 6 weeks of study, compared to baseline 3-6 weeks; over 16- 24 weeks of dosing | Use of packed red blood cells over 6 week time periods. |
| Secondary | Change in the frequency of IV iron infusions | Last 6 weeks of dosing to first 6 weeks; over 16-24 weeks of drug administration | Number of interval IV iron infusions in 6 week periods |
| Secondary | Percent change in the per bleed average epistaxis severity | The final 3 weeks to the baseline 3 weeks of the study; for a16-24 week duration study | Epistaxis severity score \[0-10\] housed in the current patient reported outcome instrument will be averaged |
| Secondary | Daily monitoring for change in systolic blood pressure [mm mercury] using daily recordings | Daily from baseline through up to 24 weeks till on-drug study completion. | Patients rising above 140 mm mercury, or those who increase by 20 or more mm mercury will trigger protocol defined treatments. |
| Secondary | Daily monitoring for change in diastolic blood pressure [mm mercury] | Daily from baseline through up to 24 weeks till on-drug study completion | Patients rising above 90 mm mercury, or those who increase by 10 mm mercury or more will trigger protocol defined treatments. |
| Secondary | Number of participants with changes in alanine aminotransferase [liver function test] | Baseline and throughout the 16-24 week dosing period | measurement every 3 weeks to evaluate fold increase with use of drug |
| Secondary | Monitor for active and safe trough serum drug concentrations | Over 16-24 week duration of study; once at steady state for each administered dose | Assays to be analyzed to evaluate the exposures done to remain within safe and effective range \[1ug/ ml to 10ug/ml\]..... |
| Secondary | Evaluate for change in composite mental quality of life scores | baseline, week 12 and at study drug-dosing end; 16, 20 or 24weeks | short form health survey 36 \[range 1-100, higher number representing better self-reported mental health\] |
| Secondary | Evaluate for change in composite physical quality of life scores | baseline, week 12 and at study drug-dosing end; up to 24 weeks. | short form health survey 36 \[range 1-100, higher number representing better self-reported physical health\] |
| Secondary | Evaluate for change in fatigue composite scores | baseline and study end; up to 24 weeks | Patient-report outcome measurement information system-fatigue; \[0-100 scale; lower number representing less fatigue\]. Queries the degree of fatigue and the implications on physical functioning. Reduction of 5 or more in the composite score represents clinically relevant reductions in fatigue. |
| Other | Interrogate levels of Iron stores | baseline and at on-drug study end; 16, 20 or 24 weeks depending on study duration | Ferritin serum levels \[normal range 12 ug/ ml to 150ug/ml female, 300ug/ ml male\]. However, above 30ug/ ml valued as relevant for proper erythropoiesis\] |
| Other | Characterize change in left ventricular stress | baseline and on-drug study end; 16, 20 or 24 weeks depending on study duration] | NTproBNP serum values represent a surrogate for left ventricular stress \[\<125pg/ml normal, while above 350pg/ml high and potentially consistent with heart failure\] |
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/NCT03850730/registered