EUCTR2019-001213-17-IT进行中（未招募）1 期
A Multicenter, Open-label, Randomized Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide in Patients with Chronic Hepatitis Delta - MYR301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MYR GmbH
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of signed and dated informed consent form.
- •2. Male or female, aged 18-65 years (inclusive).
- •3. Positive serum anti-HDV antibody results or PCR results for serum/plasma HDV RNA for at least 6 months before Screening.
- •4. Positive PCR results for serum/ plasma HDV RNA at Screening.
- •5. Alanine transaminase level >1 x ULN, but less than 10 x ULN.
- •6. Serum albumin >2.8 mg/dL.
- •7. Negative urine pregnancy test for females of childbearing potential.
- •8. Inclusion criteria for female subjects:
- •Postmenopausal for at least 2 years, or
- •Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or
- •Abstinence from heterosexual intercourse throughout the study, or
- •Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or
- •intrauterine contraceptive) throughout the study and for 3 months after the last dose of the study medication.
- •9. Male subjects must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) and not to donate sperm throughout the study and for 3 months after the last dose of the study medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 148
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Child-Pugh hepatic insufficiency score over 7 points. Uncomplicated oesophageal varices allowed; Subjects with current bleeding or ligation, or history of bleeding or ligation within the last 2 years are excluded.
- •2. HCV or uncontrolled HIV coinfection. Subjects with HCV antibodies can be enrolled, if screening HCV RNA test is negative. Subjects with HIV infection can be enrolled if CD4+ cell counts are >500/mL and HIV RNA is below limit of detection for at least 12 months.
- •3. Creatinine clearance < 60 mL/min as estimated using Cockcroft-Gault formula.
- •4. Total bilirubin = 34.2 µmol/L. [Patients with higher total bilirubin values may be included after the consultation with the Study Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.]
- •5. Evidence of an active or suspected malignancy or a history of malignancy, or an untreated pre-malignancy disorder within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to screening [and no more than 3 excised skin cancer within the last 5 years prior to screening]) or history of hepatic carcinoma.
- •6. Systemic connective tissue disorders.
- •7. NYHA (New York Heart Association) class III-IV congestive heart failure.
- •8. Patients with uncontrolled arterial hypertension within 3 months prior to start of clinical phase of the study. [Patients with systolic blood pressure > 150 mm Hg or diastolic blood pressure > 100 mm Hg despite antihypertensive treatment at Screening can be included after the confirmation of the Study Medical Monitor].
- •9. Previous or unstable concurrent diseases or conditions that prevent subject's enrolment into the study.
- •10. Patients with mental disorders or social circumstances that preclude them from following protocol requirements.
- •11. Current or previous (within last 2 years) decompensated liver disease, including coagulopathy, hepatic encephalopathy and esophageal varices hemorrhage.
- •12. One or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.). Gilbert's syndrome, a benign disorder associated with low-grade hyperbilirubinemia, will not exclude patients from participation in this trial.
- •13. White blood cells (WBC) count < 3000 cells/mm3 (<1500 if African patients).
- •14. Neutrophil count < 1500 cells/mm3 (<1000 if African patients).
- •15. Platelet count < 60,000 cells/mm3.
- •16. Use of prohibited psychotropic agents at Screening.
- •17. Use of interferons within 6 months before Screening.
- •18. History of solid organ transplantation.
- •19. Current alcohol abuse or alcohol abuse within 6 months prior to enrolment in this study; past or current drug addict.
- •20. History of disease requiring regular use of systemic glucocorticosteroids (inhalative glucocorticosteroids are allowed) or other immunosuppressants.
- •21. Pregnant or breast-feeding females.
- •22. Participation in another clinical study with investigational drugs within 30 days prior to randomization.
- •23. Receipt of bulevirtide previously, e.g. in clinical trials.
- •24. Inability to follow protocol requirements
研究者
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