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
Condition: Chronic Hepatitis D Infection With Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis D; Hepatitis D, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, open-label, randomized clinical trial 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
    

Detailed description: 
      This is a multicenter, open-label, randomised, phase II study.

      The study will be conducted in Russia and Germany. The study is designed to evaluate the
      benefit of 3 MXB doses versus observation in patients on background therapy with tenofovir,
      suffering from hepatitis delta with very limited therapeutic options; the patients will be
      randomized 1:1:1:1 into 3 treatment arms and an observation arm. Patients with compensated
      cirrhosis at screening will be stratified to allow similar distribution into each treatment
      arm. If patients were not receiving treatment with nucleoside/nucelotide analogue, the
      comparator/background drug will be initiated after the eligibility confirmation, for 12 weeks
      prior to randomization visit; patients who previously received tenofovir will continue the
      dosing; patients on different nucleoside/nucleotide analogue will be switched to tenofovir.
      Observation is considered an adequate control group, as daily placebo injections for 24 weeks
      are regarded not feasible and ethically questionable.

      It is planned to screen 200 patients, and 120 patients will be randomised into four treatment
      arms in the 1:1:1:1 ratio.

        -  Arm A (30 patients): Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks +
           tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.

        -  Arm B (30 patients): Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks +
           tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.

        -  Arm C (30 patients): Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks +
           tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.

        -  Arm D (30 patients): tenofovir treatment for 48 weeks.
    

Intervention name(s): Myrcludex B; Myrcludex-B; Myrcludex-B; Tenofovir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 mg, once daily, subcutaneously; 5 mg, once daily, subcutaneously; 10 mg, once daily, subcutaneously; tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
Other intervention name(s): Viread
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Open-label, Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis D