Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Phase 2 Study of HQK-1001 in Sickle Cell Disease
Brief Summary: The purpose of this study is to evaluate the effects of HQK-1001 on Hb F in subjects with sickle cell disease.


Options:
A: Inclusion Criteria:

Patients meeting all of the following criteria will be considered for admission to the trial:

* Diagnosis of NTDT;
* Ages 18-65 years;
* ECOG: 0\~2 scores;
* Sign an informed consent agreeing to the clinical trial participation.

Exclusion Criteria:

Patients presenting with any of the following criteria will not be included in the trial:

* Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;
* Women during Pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures;
* Patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases;
* Patients Allergic to the drug ingredients;
* Patients with any Mental problem;
* Patients had Participated in other drug clinical trials in the past 1 month;
* Patients had a history of venous or arterial thrombosis;
* In certain circumstances that the researchers determined it was not suitable for the research.
B: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
C: Inclusion Criteria:

* Patients meeting all of the following criteria will be considered for admission to the trial:

  * Diagnosis of NTDT;
  * Ages 18-65 years;
  * ECOG: 0\~2 scores;
  * If not blood transfusion,the level of HB\<90g/dl, or blood transfusion to maintain the HB;
  * Sign an informed consent agreeing to the clinical trial participation.

Exclusion Criteria:

* Patients presenting with any of the following criteria will not be included in the trial:

  * Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;
  * Women during Pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures;
  * Patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases;
  * Patients Allergic to the drug ingredients;
  * Patients with any Mental problem;
  * Patients had Participated in other drug clinical trials in the past 1 month;
  * Patients had a history of venous or arterial thrombosis;
  * In certain circumstances that the researchers determined it was not suitable for the research.
D: Inclusion Criteria:

* Beta-thalassemia and beta thalassemia-hemoglobin E (HbE), as confirmed by DNA testing
* Transfusion independent for at least 120 days before study entry
* Red blood cell folate levels above the lower limit of normal

Exclusion Criteria:

* Absolute neutrophil count (ANC) less than 2000/mm3 in the 8 weeks before study entry or a history of chronic neutropenia, defined as an ANC less than 2000/mm3
* Platelet count less than 100,000/mm3 or greater than 1,000,000/mm3 in the 8 weeks before study entry
* Family history of an inherited disease resulting in low ANC or bone marrow failure
* Serum creatinine level greater than 2 mg/dL in the 8 weeks before study entry
* Evidence of liver disease, as defined by one or more of the following conditions:

  1. Alanine aminotransferase (ALT) level greater than 3 times the upper limit of normal in the 8 weeks before study entry
  2. Serum albumin level less than 3 g/dL in the 8 weeks before study entry
  3. Evidence of cirrhosis on liver biopsy obtained in the 6 months before study entry
* Approaching death; has concurrent liver, kidney, cardiac, or metabolic disease; or has any disease of such severity that death within 7 to 10 days of study entry is likely
* Pregnant, planning to become pregnant, or breastfeeding
* Sexually active female of childbearing potential who is unwilling to use at least two acceptable methods of contraception, as determined by the investigator
* Sexually active male whose partner is of child-bearing potential and who is unwilling to use at least two acceptable methods of contraception, as determined by the investigator, during and for 2 months after decitabine treatment
* Diagnosed with cancer (except non-melanoma skin cancer) in the 5 years before study entry. In particular, suspicion or evidence of myelodysplastic syndrome (MDS) on clinically indicated bone marrow aspirate or a family history of MDS or concurrent leukemia
* HIV infection
* Not expected to be able to complete 24 weeks of study follow-up
* Currently being treated with any experimental or fetal hemoglobin modulating agent
* Current participation in any other studies of investigational drugs or devices
* Unable to comply with study medication regimen
* Any condition, which in the opinion of the investigator, would place the individual at undue risk if treated with twice-weekly low-dose decitabine for 12 weeks

Answer: B