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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01322269
Other study ID # HQP 1001-SCD-006
Secondary ID
Status Completed
Phase Phase 2
First received March 22, 2011
Last updated June 11, 2013
Start date April 2011

Study information

Verified date June 2013
Source HemaQuest Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardJamaica: Ministry of HealthEgypt: Ministry of Health and PopulationEgypt: Institutional Review BoardLebanon: Institutional Review BoardCanada: Health CanadaCanada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of three dose levels of HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease.


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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
HQK-1001
HQK-1001 tablets, once daily for daily 26 weeks

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Sponsors (1)

Lead Sponsor Collaborator
HemaQuest Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Canada,  Egypt,  Jamaica,  Lebanon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Physical exams, vital signs, clinical laboratory safety assessments, ECG and adverse event monitoring. Day 1 through Week 30 Yes
Secondary Fetal hemoglobin levels Day 1 and Weeks 4, 8, 12, 16, 20, 25, 26 and 30 No
Secondary Incidence of sickle cell crisis events Day 1 through Week 30 No
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