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Clinical trial

Phase 2b Study of Bulevirtide (With Peginterferon Alfa-2a) in Patients With CHD

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Last updated:31st May 2019
Identifier: NCT03852433

Brief Summary:
This is Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination with Pegylated Interferon alfa-2a in Patients with Chronic Hepatitis Delta

Detailed Description:
A Multicenter, Open-label, Randomized Phase 2b Clinical Study. Approximately 25 study sites in approximately 4 countries globally which may include Russia, France, Moldova, Romania.
There is currently no approved drug for treatment of chronic hepatitis Delta (CHD). Pegylated interferon alfa -2a (PEG-IFN alfa) is approved for treatment of chronic hepatitis ? virus (HBV) infection which is required for the propagation of hepatitis Delta virus (HDV), and used to treat patients with HDV infection with evidence of some virologic efficacy. Interferon has a complex mode of action, whereas direct antiviral effects and immunomodulatory mechanisms have been described. Bulevirtide is an entry inhibitor has demonstrated significant virologic and biochemical activity in patients with HDV infection during the Phase 2 clinical trials. A combination of the both drugs demonstrated significant synergistic effects in the 201 clinical trial. It is therefore warranted to further investigate the combination therapy with the aim of improvement of sustained virologic response rates.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, Open-label, Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis Delta
Actual Study Start Date: May 31, 2019
Estimated Primary Completion Date: February 28, 2023
Estimated Study Completion Date: February 28, 2023

Arms:
- Active Comparator:
Arm A - Peginterferon alfa-2a
- Experimental: Arm B - Bulevirtide 2 mg/day
- Experimental: Arm C - Bulevirtide 10 mg/day
- Experimental: Arm D - Bulevirtide 10 mg/day

Category Value
Date last updated at source 2019-08-28
Study type(s) Interventional
Expected enrolment 175
Study start date 2019-05-31
Estimated primary completion date 2023-02-28

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