Trial · NCT02336373
Treatment of Hemoglobin SC Disease With Hydroxyurea
NCT02336373, Phase 2, Terminated, Baylor College of Medicine; results first posted 2020-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Hemoglobin SC Disease With Hydroxyurea. Trials, record NCT02336373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02336373
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Hemoglobin SC Disease With Hydroxyurea
- NCT number
- NCT02336373
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Hemoglobin SC Disease
- Interventions
- hydroxyurea
- First posted
- 2015-01-13
- Last updated
- 2020-09-09
- Results first posted
- 2020-09-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in PedsQL SCDM | 6 months | Mean change in PedsQL™ Sickle Cell Disease Module version 3.0 score after achieving MTD compared with baseline. PedsQL™ Sickle Cell Disease Module version 3.0 scores are on a 100 point scale ranging from 0 to 100 with higher values indicating better quality of life. PedsQL: pediatric qulaity of life |
| Secondary | Change in HVR at 45s-1 | up to 7 months | Change in hematocrit to viscosity ratio (HVR) at 45s-1 at follow-up versus baseline. This is a measure of oxygen carrying capacity, as a higher hematocrit with lower viscosity indicates ability to deliver oxygen without slowed blood flow due to high viscosity or blood thickness. Higher values are associated with improvement. |
| Secondary | Change in HVR at 225s-1 | up to 7 months | Change in hematocrit viscosity ratio at 225s |
| Secondary | DRBC | up to 7 months | Change in percent dense red blood cells |
| Secondary | Change in HbF | up to 7 months | Change in fetal hemaglobin |
| Secondary | Change in MCV | up to 7 months | Change in mean corpuscular volume |
| Secondary | Change in MCHC | up to 7 months | Change in mean corpuscular hemoglobin concentration |
| Secondary | Change in Hb | up to 7 months | Change in hemoglobin |
| Secondary | Change in ARC | up to 7 months | Change in absolute reticulocyte count |
| Secondary | Change in ANC | up to 7 months | Change in absolute neutrophil count |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in PedsQL SCDM | 6 months | Participants who achieved MTD of hydroxyureq per protocol with observed PEDSQL scores at 6-months and baseline (study entry). | Score on PedsQL 3.0 SCD Module | MEAN |
| SECONDARY | Change in HVR at 45s-1 | up to 7 months | au | MEAN | |
| SECONDARY | Change in HVR at 225s-1 | up to 7 months | au | MEAN | |
| SECONDARY | DRBC | up to 7 months | percentage of dense red blood cells | MEAN | |
| SECONDARY | Change in HbF | up to 7 months | percent | MEAN | |
| SECONDARY | Change in MCV | up to 7 months | fL | MEAN | |
| SECONDARY | Change in MCHC | up to 7 months | percent | MEAN | |
| SECONDARY | Change in Hb | up to 7 months | percent | MEAN | |
| SECONDARY | Change in ARC | up to 7 months | 10^3 cells/uL | MEAN | |
| SECONDARY | Change in ANC | up to 7 months | 10^3 cells/uL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in PedsQL SCDM | Hydroxurea | 5.7 | Standard Deviation 15.5 | Score on PedsQL 3.0 SCD Module | |
| Change in HVR at 45s-1 | Hydroxyurea | 0.083 | Standard Deviation 0.72 | au | |
| Change in HVR at 225s-1 | Hydroxyurea | 0.11 | Standard Deviation 0.83 | au | |
| DRBC | Hydroxyurea | 1.93 | Standard Deviation 20.6 | percentage of dense red blood cells | |
| Change in HbF | Hydroxyurea | -0.47 | Standard Deviation 0.94 | percent | |
| Change in MCV | Hydroxyurea | -6.2 | Standard Deviation 2.3 | fL | |
| Change in MCHC | Hydroxyurea | 0.33 | Standard Deviation 0.43 | percent | |
| Change in Hb | Hydroxyurea | -0.62 | Standard Deviation 0.59 | percent | |
| Change in ARC | Hydroxyurea | 0.01 | Standard Deviation 0.025 | 10^3 cells/uL | |
| Change in ANC | Hydroxyurea | -0.24 | Standard Deviation 0.82 | 10^3 cells/uL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydroxurea | 32 | |
| Overall Study | COMPLETED | Hydroxurea | 14 | |
| Overall Study | NOT COMPLETED | Hydroxurea | 18 |
Source ClinicalTrials.gov
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydroxurea | 0 | 32 |
| Total, other adverse events | Hydroxurea | 0 | 32 |
| Total, serious adverse events | Hydroxurea | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT02336373
GET https://conductscience.org/api/trials/v1/NCT02336373/registered