Efficacy and Safety of Myrcludex B in Chronic Hepatitis D
- Conditions
- Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Chronic Hepatitis D
- Registration Number
- EUCTR2016-000395-13-DE
- Lead Sponsor
- Hepatera LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of MXB and to compare 3 doses of MXB versus observation on background therapy with tenofovir in hepatitis delta patients.;Secondary Objective: To investigate safety and tolerability, as well as to assess pharmacokinetics and immunogenicity, of three doses of MXB in hepatitis delta patients.;Primary end point(s): •HDV RNA negativation or decrease by =2 log from baseline on Week 24. ;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Durability of HDV RNA response to 24 weeks post treatment<br>•Combined response: HDV RNA negativation or =2 log decline and normal ALT at treatment week 24<br>•Changes in ALT values on Week 24 and Week 48 compared to baseline.<br>•Lack of fibrosis progression based on transient elastometry (Fibroscan) on Week 24 compared to baseline. <br>•Changes (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin on Week 24 and Week 48 compared to baseline. <br>•Changes in HBsAg (decreased levels, disappearance of HBsAg, antibodies to HBsAg) on Week 24 and Week 48 compared to baseline.<br>•Change in HBV DNA levels on Week 24 and Week 48 compared to baseline.<br>;Timepoint(s) of evaluation of this end point: 24-48 weeks