A study of HQK-1001 in patients with sickle cell disease (clinicaltrials.gov) - Apr 11, 2012 - P2, N=52; Active, not recruiting -> Completed
Trial completion • Hematological Malignancies
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This study has been completed.
First
Received on March 22, 2011. Last
Updated on April 11, 2012 History of
Changes
Sponsor: HemaQuest Pharmaceuticals Inc.
Information
provided by (Responsible Party): HemaQuest
Pharmaceuticals Inc.
ClinicalTrials.gov
Identifier: NCT01322269
Purpose
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.
Condition
Sickle Cell Disease
Sickle Cell Anemia
Sickle Cell Disorders
Hemoglobin S Disease
Sickling Disorder Due to Hemoglobin S
Intervention
Drug: HQK-1001
Phase
Phase II
Study
Type: Interventional
Study
Design: Allocation: Randomized
Intervention
Model: Parallel Assignment
Masking:
Open Label
Primary
Purpose: Treatment
Official
Title: A Randomized, Open-Label,
Multi-Dose Study of HQK-1001 in Subjects With Sickle Cell Disease
Resource
links provided by NLM:
Genetics
Home Reference related topics: sickle cell disease
MedlinePlus
related topics: Anemia Sickle Cell Anemia
U.S.
FDA Resources
Further
study details as provided by HemaQuest Pharmaceuticals Inc.:
Primary
Outcome Measures:
Safety
[ Time Frame: Day 1 through Week 30 ] [ Designated as safety issue: Yes ]
Physical
exams, vital signs, clinical laboratory safety assessments, ECG and adverse
event monitoring.
Secondary
Outcome Measures:
Fetal
hemoglobin levels [ Time Frame: Day 1 and Weeks 4, 8, 12, 16, 20, 25, 26 and 30
] [ Designated as safety issue: No ]
Incidence
of sickle cell crisis events [ Time Frame: Day 1 through Week 30 ] [ Designated
as safety issue: No ]
Enrollment: 52
Study Start Date: April 2011
Primary Completion Date: March 2012 (Final data collection date for primary outcome
measure)
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