Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT01322269
Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of SCD
* Males and females between 12 and 60 years of age, inclusive
* At least 3 episodes of a SCD-related crisis or complication in the 3 years prior to screening OR 1 episode of acute chest syndrome in the 5 years prior to screening
* If receiving hydroxyurea, must be receiving a stable dose for at least 6 months prior to screening
* If hydroxyurea treatment has been discontinued, at least 3 months have elapsed since last dose
* If transfusion in the 4 months prior to screening, then HbA level \< 20% at screening
* Average of the initial two HbF levels ≥ 2.0 % within ≤ 7 days prior to the initial dose of HQK-1001. The two must be obtained ≥ 24 hours apart
* Ability to swallow tablets
* Able and willing to give informed consent and assent (if applicable)
* If subject is a woman of child-bearing potential (WCBP), she must have a negative serum pregnancy test within 7 days of first dose of HQK-1001
* If a subject is a WCBP, she must agree to use an effective form of contraception within 7 days of the initial dose of HQK-1001 and for one month after HQK-1001 discontinuation
* Sexually active male subjects (with WCBP partners) must agree to use latex condoms or ensure that their partner(s) use an effective form of contraception
* In the view of the Investigator, subject is able and willing to comply with necessary study procedures
Exclusion Criteria:
* More than 4 hospitalizations for acute sickle cell related events in the previous 12 months prior to screening
* Pulmonary hypertension requiring oxygen therapy
* QTc \> 450 msec (male) or 470 msec (female) on screening ECG (QT corrected by Fridericia's formula)
* Assigned to a regular transfusion program
* Use of erythropoiesis stimulating agents within 90 days of screening
* ALT \> 3x upper limit of normal (ULN)
* Serum creatinine \> 1.2 mg/dL
* A serious, concurrent illness that would limit ability to complete or comply with the study requirements
* An acute vaso-occlusive event within 3 weeks prior to screening
* Creatine phosphokinase (CK) \> 20% above the ULN
* 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
* Chronic opiate use, which, in the view of the Investigator, could confound evaluation of an investigational drug
* Current abuse of alcohol or drugs
* Received 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 patients are currently on therapy or will be placed on therapy during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
60 Years
Study:
NCT01322269
Study Brief:
Protocol Section:
NCT01322269