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Keep this study
Lead
HemaQuest Pharmaceuticals Inc.
Age
12–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females between 12 and 60 years of age
Diagnosis of SCD, type Hb SS or Hb S-B0 Thalassemia
At least 1 episode of SCD pain crisis, acute chest syndrome, other acute SCD complications, or leg ulcers in the 12 months prior to screening
Not being treated with Hydroxyurea (HU); if HU treatment has been previously administered and then discontinued, at least 3 months must have elapsed since last dose of HU
If subject has been transfused in the 3 months prior to screening, then Hb A level \< 20% at screening
Baseline Hb F level obtained within 14 days prior to randomization
Able to swallow tablets
Able and willing to give informed consent and/or assent
If subject is a woman of child-bearing potential (WCBP), she must have a negative serum pregnancy test within 14 days of first dose of HQK-1001 and a negative urine pregnancy test prior to dosing on Day 1
If a subject is a WCBP, she must agree to use an effective form of contraception starting at screening and for one month after HQK-1001 discontinuation
Sexually active male subjects who have not had a vasectomy must agree to use latex condoms with WCBP partners or ensure that their partner(s) use an effective form of contraception starting at screening and for one month after HQK-1001 discontinuation.
You may not be if
Assigned to a regular transfusion program
Use of erythropoiesis stimulating agents within 90 days prior to screening
An SCD pain crisis or SCD-related acute complication within 3 weeks prior to randomization
More than 5 SCD pain crisis or SCD-related acute complications within 12 months prior to screening
Pulmonary hypertension requiring therapy
ALT or AST \> 3x ULN
Serum creatinine \> 1.5x ULN
Serum amylase levels \> 1.5x ULN
Serum lipase level \> 1.5x ULN
A serious, concurrent illness that would limit ability to complete or comply with the study requirements
An acute illness (e.g., febrile, GI, respiratory) within 72 hours prior to screening
History of syncope, clinically significant dysrhythmias or resuscitation from sudden death due to SCD-related complication
Symptomatic peptic ulcer, hiatus hernia, or gastroesophageal reflux disease (GERD)
History of pancreatitis
Chronic opiate use, which, in the view of the investigator, could confound evaluation of an investigational drug
Current abuse of alcohol or drugs
Use of another investigational agent within 4 weeks or 5 half-lives, whichever is longer, prior to screening
Currently pregnant or breast feeding a child
Known infection with HIV-1
Infection with hepatitis B or hepatitis C, such that subjects are currently on anti-viral therapy or will be placed on therapy
Clareo Health | Effects of HQK-1001 in Patients With Sickle Cell Disease
