CTRI/2024/06/068363尚未招募2 期
A Phase IIa, double blind, randomized, placebo controlled, parallel, multicenter, proof-of-concept study to evaluate the efficacy and safety of Desidustat oral tablet for treatment of sickle cell disease - NI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Indian male and female participants with confirmed diagnosis of Sickle cell
- •disease (any genotype; Documentation of SCD genotype may be based on available
- •or history of confirmatory laboratory testing with hemoglobin electrophoresis, HPLC,
- •or genetic testing).
- •2)Hemoglobin level 7-11 g/dL for males and 6.5-11 g/dL for females (both inclusive) at
- •3)Participants have had at least 1 episode of Vaso Occlusive Crisis (VOC) in the past
- •12 months. For study eligibility, VOC is defined as a previously documented episode
- •of Acute Chest Syndrome (ACS) or acute painful crisis (for which there was no
- •explanation other than VOC) which required prescription or healthcare professionalinstructed
- •use of analgesics for moderate to severe pain (documentation must exist in
- •the patient medical record prior to Screening).
- •4) Serum ferritin level =100 ng/mL or/and TSAT = 20 % at screening
- •5) No clinically significant vitamin B12 or Folate deficiency at screening
- •6) For participants taking hydroxyurea, L-glutamine, crizanlizumab, the dose of diseasemodifying therapies must be stable for at least 60 days prior to signing the ICF.
- •7) Men and women of childbearing potential must agree to use adequate birth control
- •measures during the study. Acceptable methods of birth control in this study include:
- •surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch,
- •long-acting injectable contraceptive, partner’s vasectomy, double-barrier method
- •(condom or diaphragm with spermicide) during study participation and for 30 days
- •after their last dose of study drug.
- •8) Participant has provided signed informed written consent. In case of illiterate patients,
- •thumb impression of the patients will be obtained along with the signature of the
- •impartial witness on the consent form prior to patient’s participation in the trial.
排除标准
- •1)Participants who have received blood transfusion within 30 days prior to signing of
- •2) Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of
- •signing the ICF (i.e., hospitalization and discharge for vaso-occlusive event cannot be
- •within 14 days prior to signing the ICF).
- •3) Participants who are currently receiving Voxelotor.
- •4)Diagnosis of cirrhosis
- •5)New arterial or venous thrombosis diagnosed within 6 months of signing the ICF.
- •6)Participants who have participated in clinical trial of any other investigational product
- •or medical device other than the present trial within 3 months prior to screening.
- •7)Major surgery within 90 days prior to randomization, and minor surgery within 30
- •days prior to randomization.
- •8)History of severe allergic or hypersensitivity reaction to investigational products and
- •its excipients
- •9)Unable to swallow tablets or disease significantly affecting gastrointestinal function
- •and/or inhibiting small intestine absorption such as; mal-absorption syndrome,resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
- •10)Medical, psychological or behavioural conditions, which in the opinion of the
- •investigator, may preclude safe participation, confound study interpretation, interfere
- •with compliance, or preclude informed consent.
- •11)Participant requiring treatment with intravenous antibiotic within 14 days of
- •12)History of Hepatitis A, B, C or HIV infection or positive test for Hbs Ag, HCV or
- •HIV at screening.
- •13)Receipt of erythropoietin, Voxelotor or other hemopoietic growth factor treatment
- •within 28 days of signing ICF or anticipated need for such agent during the study.
- •14)Prior history of pancreatitis or myocardial infarction within 06 months prior to
- •15)History of significant alcoholism or drug abuse within the past 1 year. History or
- •presence of significant smoking (more than 10 cigarettes per day) or consumption of
- •tobacco/nicotine products (more than 10 times per day).
- •16)History of difficulty with donating blood.
- •17)Intravenous iron within 14 days prior to enrolment.
- •18)History of previous or concurrent cancer.
研究者
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