Chronic Hepatitis Delta MedDRA version: 20.0 Level: LLT Classification code 10019763 Term: Hepatitis delta System Organ Class: 100000004862
Conditions
Interventions
Product Name: bulevirtide
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: bulevirtide
CAS Number: 2012558-47-1
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Gilead Sciences, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 >28 g/L. 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 for patients discontinued during the treatment period. 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 for patients discontinued during the treatment period. 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
Exclusion criteria
Exclusion criteria: 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 150 mm Hg and/ or diastolic blood pressure > 100 mm Hg at Screening. 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. Autoimmune hepatitis stigmata attributed to HDV infection in the opinion of the investigator are allowed. 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 and undergo all protocol procedures. NOTE: Patients w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of bulevirtide administered subcutaneously for 48 weeks at a dose of 2 mg or 10 mg once daily for treatment of chronic hepatitis delta in comparison to delayed treatment.;Secondary Objective: To evaluate optimal treatment duration. To assess the safety of bulevirtide.;Primary end point(s): Combined response at week 48. Combined response is defined as fulfilment of two conditions simultaneously: - Undetectable (< LoD) HDV RNA or decrease by = 2 log10 IU/ml from baseline - ALT normalization;Timepoint(s) of evaluation of this end point: see above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Undetectable HDV RNA at week 48 • ALT normalization at week 48 • Undetectable HDV RNA 24 weeks after scheduled end of treatment (sustained virological response) • Undetectable HDV RNA 48 weeks after scheduled end of treatment (sustained virological response) • Change from baseline in liver stiffness as measured by elastography at week 48, 96, 144, 192 and 240 ;Timepoint(s) of evaluation of this end point: see above. | — |
Countries
Germany, Italy, Russian Federation, Sweden, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed