At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 86 enrolled
Drug / intervention
Hydroxycarbamide +1 moredrug
Likely dose
Hydroxycarbamide 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicentre Randomized Double-blind Placebo-controlled Study to Evaluate the Effect on Albuminuria of 6 Months Treatment With Hydroxycarbamide (Siklos®) or a Placebo in Adults With Sickle Cell Disease:
In Brief
A Phase 2 clinical trial evaluating Hydroxycarbamide and Placebo Oral Tablet for Sickle Cell Disease. Completed, enrolled 86 participants across 21 sites in 6 countries.
Detailed Summary
The purpose of this phase IIb, international, multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 6 months of treatment in SCD adult patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesCôte d’Ivoire, France, Guadeloupe, Mali, Martinique, Senegal
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartMay 2019
Primary CompletionMay 2024
TodayJul 2026
First PostedJan 16, 2019
Enrollment StartMay 28, 2019
Primary CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.5 years ago
Interventions
Hydroxycarbamidedrug
Hydroxycarbamide tablets of 100 and 1000 mg
Placebo Oral Tabletdrug
Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets