Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
Condition: Chronic Viral Hepatitis B With Delta-agent
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Myrcludex B; PEG IFN alfa-2a; Tenofovir
Intervention description: Lyophilised powder for solution for subcutaneous injection; solution for subcutaneous injection, once per week; Film-coated tablets, 300 mg, per os, once daily
Intervention MeSH terms: Tenofovir; Peginterferon alfa-2a; Interferon alpha-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Open-label, Randomized, Comparative, parallel-arm phase II study
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in
      Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with
      Chronic Viral Hepatitis B with Delta-agent
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed Informed Consent form.

          2. Males and females 18 to 65 years of age (inclusively).

          3. Patients with chronic hepatitis B (HBeAg-positive or negative) and HBsAg-positive for
             at least 6 months prior to Screening.

          4. Positive for anti-HDV antibodies for at least 6 months prior to Screening.

          5. HDV RNA-positive at Screening.

          6. ALT ≥ 1 x ULN and < 10 x ULN.

          7. The patient agreed to use adequate method of contraception during the study, starting
             from the time of Informed Consent signing and until completion of the Follow-up
             Period.

        Exclusion Criteria:

          1. Intolerance or hypersensitivity to the active ingredient or other components of the
             study drug Myrcludex B.

          2. Intolerance or hypersensitivity to interferons alfa, genetically engineered E.coli
             medications, polyethylene glycol or other components of peginterferon alfa-2a.

          3. Previous treatment with Myrcludex B (patients with previous exposure to interferon are
             eligible).

          4. Therapy with antiviral drugs for chronic viral hepatitis B with delta-agent over the
             previous 6 months.

          5. Therapy with anti-tumour agents (including radiotherapy) or immunomodulatory
             medications (including systemic glucocorticoids) over the previous 6 months.

          6. The following laboratory test results at Screening:

               1. Hemoglobin < 100 g/L

               2. Leucocytes < 3000/µL

               3. Neutrophils < 1500/µL

               4. Platelets < 90000/µL

               5. Serum creatinine >1.5 x ULN.

          7. Total bilirubin > 34.2 µM/L. Patients with higher total bilirubin may be enrolled upon
             consultation with the study Medical Monitor, if there is clear evidence that the
             elevated bilirubin is caused by Gilbert's syndrome.

          8. Current or previous decompensated liver disease, including coagulopathy,
             hyperbilirubinemia, hepatic encephalopathy, hypoalbuminaemia, ascites, and oesophageal
             varices haemorrhage; Child-Pugh score of B/C or ≥6 points.

          9. HCV or HIV coinfection (patients with anti-HCV antibodies and no HCV RNA at Screening
             are eligible).

         10. Hepatocellular carcinoma.

         11. Signs of drug- or alcohol-induced liver disease or any other medical conditions
             associated with chronic liver disease (e.g. autoimmune hepatitis, hemochromatosis,
             thalassaemia, alcoholic hepatitis, toxic liver disease).

         12. Contraindications for liver biopsy.

         13. Concurrent malignancy (current diagnosed or suspected malignancy; risk of a previous
             malignancy recurrence).

         14. Severe decompensated cardiovascular diseases, including unstable and poorly controlled
             conditions, over 6 months before Screening.

         15. History of poorly controlled thyroid conditions or clinically significant signs of
             thyroid dysfunction at Screening.

         16. Previous or current severe renal failure or significant renal dysfunction at
             Screening.

         17. Previous or current chronic pulmonary disease with respiratory distortion at
             Screening.

         18. Previous or current severe retinopathy, significant ophthalmology disorders associated
             with diabetes mellitus or hypertension.

         19. Previous or current severe psychiatric disorders at Screening (e.g. severe
             depressions, suicidal attempts, severe neuroses or cognitive disorders).

         20. Previous or current endocrine disorders (hypoglycaemia, hyperglycaemia, diabetes
             mellitus) that are not adequately controlled at Screening.

         21. History of visceral organ transplantation.

         22. Signs of drug and/or alcohol dependence (80 g of alcohol/day for men and 40 g of
             alcohol/day for women) within 1 year before Screening.

         23. History of immune disorders (e.g. idiopathic thrombocytopenic purpura, lupus
             erythematosus, sclerodermia, severe psoriasis, rheumatoid arthritis).

         24. Need for concomitant use of glucocorticoids or myelotoxic agents.

         25. Participation in another clinical study within 30 days prior to enrollment into this
             study.

         26. Pregnant or breast-feeding females.

         27. Any other condition that, in the opinion of Investigator, precludes the patient from
             taking part in this study.