Trial · NCT04218084
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Time-Averaged Maximum of Mean Velocity (TAMMV) Arterial Cerebral Blood Flow at Week 24 | Baseline (value at screening), Week 24 | TAMMV is an ultrasound measurement used in transcranial Doppler (TCD) to assess blood flow in cerebral arteries. TCD flow velocities were categorized as follows: (i) Normal: \< 170 centimeter per second (cm/sec); (ii) Conditional: 170 to \< 200 cm/sec - the eligible participant population for this study; (iii) Abnormal: \>= 200 cm/sec. |
| Secondary | Change From Baseline in TAMMV Arterial Cerebral Blood Flow at Week 48 | Baseline (value at Screening), Weeks 48 | TAMMV is an ultrasound measurement used in TCD to assess blood flow in cerebral arteries. TCD flow velocities were categorized as follows: (i) Normal: \< 170 cm/sec; (ii) Conditional: 170 to \< 200 cm/sec - the eligible participant population for this study; (iii) Abnormal: \>= 200 cm/sec. |
| Secondary | Time to Conversion to Abnormal TCD Flow | Up to 96 weeks | Time to conversion was the number of weeks from the date of randomization to the date of first determined TCD assessment when an abnormal TCD flow velocity (\>= 200 cm/sec) was determined. TCD flow velocities were categorized as follows: (i) Normal: \< 170 cm/sec; (ii) Conditional: 170 to \< 200 cm/sec - the eligible participant population for this study; (iii) Abnormal: \>= 200 cm/sec. The stratified Log Rank Test was stratified by stratification factors: baseline HU use (yes; no), age group (2 to \<= 8 years; \>8 to \<15 years), and baseline TAMMV value (170 cm/sec to \< 185 cm/sec; 185 cm/sec to \< 200 cm/sec). |
| Secondary | Time to Reversion to Normal TCD Flow | Up to 96 weeks | TCD was used to assess cerebral artery blood flow velocity in children with sickle cell disease (SCD). Time to first normal TCD flow was the number of weeks from randomization to the date of first determined normal TCD flow. Normal is \< 170 cm/sec. |
| Secondary | Percentage of Participants With TAMMV Reduced by >=15 cm/Sec From Baseline at Weeks 24, 48 and 96 | At Weeks 24, 48 and 96 | In this outcome measure, percentage of participants whose TAMMV reduced by \>=15 cm/sec from Baseline at Weeks 24, 48 and 96 is reported. TAMMV is an ultrasound measurement used in TCD to assess blood flow in cerebral arteries. TCD flow velocities are categorized as follows: (i) Normal: \< 170 cm/sec; (ii) Conditional: 170 to \< 200 cm/sec - the eligible participant population for this study; (iii) Abnormal: \>= 200 cm/sec. |
| Secondary | Change From Baseline in Hemoglobin (Hb) at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | Change from baseline in hemoglobin at weeks 24, 48 and 96 were reported in this outcome measure. |
| Secondary | Percent Change From Baseline in Unconjugated Bilirubin at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | Percent change from baseline in unconjugated bilirubin at weeks 24, 48 and 96 was reported in this outcome measure. |
| Secondary | Percent Change From Baseline in Reticulocyte at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | Percent change from baseline in reticulocyte at weeks 24, 48 and 96 was reported in this outcome measure. |
| Secondary | Percent Change From Baseline in Absolute Reticulocyte at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | Percent change from baseline in absolute reticulocyte at weeks 24, 48 and 96 was reported in this outcome measure. |
| Secondary | Percent Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | Percent change from baseline in LDH at weeks 24, 48 and 96 was reported in this outcome measure. |
| Secondary | Annualized Incidence Rate of Vaso-Occlusive Crises (VOCs) | From randomization to the last dose date, post-randomization HU initiation with no HU at baseline, end of study or study termination, whichever occurred earlier (maximum up to 110 weeks) | VOC was defined as a composite of acute painful crisis and/or acute chest syndrome (ACS). Annualized incidence rate was defined as total number of events per total person-years on treatment. Total person-years was the sum of participants treatment period in years, which included the time from randomization date to the earliest of (last dose date, post-randomization HU initiation for participants with no HU at baseline, end of study, or study termination). The 95% CI of rate displayed the exact Poisson confidence limits. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04218084/registered