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Dose-Finding Study of SC411 in Children With Sickle Cell Disease — SCOT  

Sickle Cell Disease Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study and Open-Label Extension of SC411 in Children With Sickle Cell Disease

Clinical Trial Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study of SC411 in children with sickle cell disease (SCD). The primary objective of the study is to evaluate the safety and tolerability of three different doses of SC411 compared to a placebo. All patients will undergo eight weeks of oral study treatment and a four-week safety follow-up period. Patients will be randomized to one of three dose levels of SC411 or placebo.

Clinical Trial Description

This Phase 2 study is to be conducted in two parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding study of SC411 in children with SCD. This part of the study will consist of a screening period of up to 2 weeks, followed by an eight-week treatment period. Part B is an optional 49-month open-label extension for patients who have completed Part A. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02973360
Study type Interventional
Source Micelle BioPharma Inc
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 2, 2017
Completion date January 2, 2022
View Details
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