Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIA Study of Subcutaneous 5-aza-2'- Deoxycytidine (Decitabine) in Patients With Thalassemia Intermedia
Brief Summary: Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low levels of hemoglobin. Decitabine is a medication that may be effective at increasing hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at increasing hemoglobin levels in people with TI.


Options:
A: 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
B: Inclusion Criteria:

1. Intermedia α-Thalassemia; intermedia β-Thalassemia; severe β-Thalassemia.
2. Syndrome of Deficiency of Liver-yin and Kidney-yin, and Asthenia of Essence and Blood.
3. Male or female, 3-40 years of age.
4. Provision of written informed consent.

Exclusion Criteria:

1. Complications with critical illness such as cerebrovascular disease, cardiovascular disease, hepatic disease, renal disease, malignancy and etc.
2. Allergy to any ingredients of Yisui Shengxue Granules
3. Psychiatric disorder.
4. Blood transfusion in the latest 90 days for severe β-Thalassemia; blood transfusion in the latest 45 days for intermediaβ-Thalassemia or intermedia α-Thalassemia.。
5. Upper respiratory tract infection with temperature higher than 38.5℃ in the latest 45 days.
6. Taking other antianemic agents in the latest 2 months.
7. Participation in any other clinical interventional trial in the latest 1 month.
C: Inclusion Criteria:

* Patients with thalassemia intermedia. Diagnosis based on genetic mutations, hemoglobin electrophoresis and characteristic clinical data at presentation.
* Require different transfusion requirements and not transfusion dependent.
* Have a baseline hemoglobin of less than or equal to 6-8g/dl.
* Patients with normal renal and liver function.

Exclusion Criteria:

* Evidence of active hepatitis (ALT \> 5 times above ULN).
* Evidence of renal impairment (serum creatinine \> ULN).
* Patients who are dependent on red blood cell transfusions.
D: 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

Answer: A