EUCTR2016-000395-13-DE进行中（未招募）1 期
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D - Myrcludex B in chronic hepatitis D
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Hepatera LLC
- 入组人数
- 120
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. Age from 18 to 65 years inclusively at the time of signing Informed Consent Form.
- •2. Positive serum HBsAg for at least 6 months before Screening.
- •3. Positive serum anti-HDV antibody for at least 6 months.
- •4. Positive PCR results for serum HDV RNA at Screening.
- •5. Patients with liver cirrhosis, irrespective of previous interferon treatment .
- •6. Patients without liver cirrhosis, who failed prior interferon treatment or for whom, in the opinion of the Investigator, such treatment is currently contraindicated (including history of interferon intolerance) .
- •7. Alanine aminotransferase level >1 x ULN, but less than 10 x ULN.
- •8. Previous nucleotide/nucleoside analogue treatment within at least 12 weeks prior to the planned start of study treatment or subject’s willingness to take tenofovir for at least 12 weeks prior to the planned start of study treatment.
- •9. Negative urine pregnancy test for females of childbearing potential.
- •10. 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.
- •11. 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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Child-Pugh score of B-C or over 6 points.
- •2. HCV or HIV coinfection. Subjects with anti-HCV antibodies can be enrolled, if screening HCV RNA test is negative.
- •3. Creatinine clearance <60 mL/min.
- •4. Total bilirubin = 2mg/dL. Patients with higher total bilirubin values may be included after the consultation with the Study`s Medical Monitor, if such elevation can be clearly attributed to Gilbert’s syndrome associated with low-grade hyperbilirubinemia.
- •5. Any previous or current malignant neoplasms, including 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 (BP >150/100 mm Hg despite antihypertensive treatment) within 3 months prior to start of clinical phase of the study.
- •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 decompensated liver disease, including coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminaemia, ascites, and esophageal varices hemorrhage.
- •12. WBC count <3000 cells/mm3.
- •13. Neutrophil count <1500 cells/mm3.
- •14. Platelet count <60,000 cells/mm3.
- •15. Use of prohibited psychotropic agents at Screening.
- •16. Use of interferons within 30 days before Screening.
- •17. History of solid organ transplantation.
- •18. Current alcohol abuse or alcohol abuse within 6 months prior to enrolment in this study.
- •19. History of disease requiring regular use of systemic glucocorticosteroids.
- •20. Pregnant or breast-feeding females.
- •21. Participation in another clinical study within 30 days prior to Screening.
- •22. Prior treatment with Myrcludex B in previous studies.
研究者
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