Trial · NCT01966731
Realizing Effectiveness Across Continents With Hydroxyurea (REACH)
NCT01966731, Phase 1, Phase 2, Active not recruiting, Children's Hospital Medical Center, Cincinnati; results first posted 2020-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Realizing Effectiveness Across Continents With Hydroxyurea (REACH). Trials, record NCT01966731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01966731
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Realizing Effectiveness Across Continents With Hydroxyurea (REACH)
- NCT number
- NCT01966731
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 635 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Sickle Cell Disease
- Interventions
- Hydroxyurea
- First posted
- 2013-10-22
- Last updated
- 2026-06-30
- Results first posted
- 2020-11-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Dose Limiting Toxic Events | 3 months | An expected toxicity rate of 20% and acceptable toxicity rate of 30% were used for statistical calculations. After 53 participants at each site complete 3 months of therapy, if ≤ 15 participants have hematologic toxicity there is no early evidence against safety. If ≥ 15 of the initial participants experience toxicity, this is early evidence against safety. Future participants will begin at a lower dose of hydroxyurea (10 ± 2.5 mg/kg), with another 53 participants recruited of the same safety analysis. Upon final analysis of 133 participants at the same starting dose, safety for fixed-dose hydroxyurea can be concluded. |
| Secondary | Efficacy of Hydroxyurea | Assessed every 4 ± 1 weeks up to 204 months | The efficacy of hydroxyurea will be primarily assessed through fetal hemoglobin (HbF), comparing treatment with baseline values. Additional measures of laboratory efficacy will include changes in Hb, MCV, WBC, ANC, ARC, and bilirubin. Clinical events such as vaso-occlusive pain will be captured as secondary outcomes. |
| Secondary | Medication Adherence and the Ability for Families to Adhere to Monthly Clinic Visits Are Important Feasibility Outcomes | Assessed every 4 ± 1 weeks up to 204 months | Hydroxyurea treatment will be dispensed only 35 days at a time, requiring a clinic visit every 4 ± 1 weeks. Medication adherence and the ability for families to adhere to monthly clinic visits are important feasibility outcomes |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Dose Limiting Toxic Events | 3 months | N= number of participants analyzed for toxicity during the first 3 months of trial therapy | percentage of participants | NUMBER |
| SECONDARY | Efficacy of Hydroxyurea | Assessed every 4 ± 1 weeks up to 204 months | |||
| SECONDARY | Medication Adherence and the Ability for Families to Adhere to Monthly Clinic Visits Are Important Feasibility Outcomes | Assessed every 4 ± 1 weeks up to 204 months |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Dose Limiting Toxic Events | Hydroxyurea | 5.1 | 95% Confidence Interval 3.5 to 7.3 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydroxyurea | 635 | |
| Overall Study | Initiated Hydroxyurea | Hydroxyurea | 606 | |
| Overall Study | Completed 3 Months of Treatment | Hydroxyurea | 600 | |
| Overall Study | Completed Study | Hydroxyurea | 0 | |
| Overall Study | COMPLETED | Hydroxyurea | 0 | |
| Overall Study | NOT COMPLETED | Hydroxyurea | 635 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vaso-occlusive pain | Blood and lymphatic system disorders | Hydroxyurea | 353 | 635 | 755 |
| other | Fever NOS | General disorders | Hydroxyurea | 175 | 635 | 258 |
| other | Infection unidentified | Infections and infestations | Hydroxyurea | 72 | 635 | 97 |
| other | Malaria | Infections and infestations | Hydroxyurea | 216 | 635 | 376 |
| other | Sepsis | Infections and infestations | Hydroxyurea | 37 | 635 | 41 |
| other | Skin Infection | Infections and infestations | Hydroxyurea | 114 | 635 | 184 |
| other | Upper respiratory infection | Infections and infestations | Hydroxyurea | 218 | 635 | 414 |
| other | Aspartate aminotransferred | Investigations | Hydroxyurea | 37 | 635 | 39 |
| other | Blood bilirubin increased | Investigations | Hydroxyurea | 44 | 635 | 52 |
| other | Hemoglobin decreased | Investigations | Hydroxyurea | 239 | 635 | 451 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydroxyurea | 16 | 635 |
| Total, other adverse events | Hydroxyurea | 500 | 635 |
| Total, serious adverse events | Hydroxyurea | 66 | 635 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT01966731
GET https://conductscience.org/api/trials/v1/NCT01966731/events?page=2