Bulevirtide
- Generic Name
- Bulevirtide
- Brand Names
- Hepcludex
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 2012558-47-1
- Unique Ingredient Identifier
- WKM56H3TLB
- Background
Hepatitis D is considered the most severe type of viral hepatitis and leads to the rapid development of cirrhosis, severe decompensation of liver function, and an increased risk of mortality. Until recently, there have been extremely limited treatments available for Hepatitis D infection.
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- Indication
Bulevirtide is indicated for the treatment of chronic Hepatitis D infection in HDV-RNA positive adult patients with compensated liver disease.
- Associated Conditions
- Hepatitis D
- Associated Therapies
- -
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
- First Posted Date
- 2024-07-16
- Last Posted Date
- 2024-07-16
- Target Recruit Count
- 192
- Registration Number
- NCT06504485
- Locations
- 🇮🇹
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy., Milano, Italy
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
- First Posted Date
- 2024-05-03
- Last Posted Date
- 2024-06-17
- Target Recruit Count
- 266
- Registration Number
- NCT06397859
- Locations
- 🇮🇹
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy., Milano, Italy
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
- First Posted Date
- 2023-11-08
- Last Posted Date
- 2024-05-07
- Target Recruit Count
- 100
- Registration Number
- NCT06122285
- Locations
- 🇮🇹
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy., Milan, MI, Italy
Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
- Conditions
- First Posted Date
- 2023-09-22
- Last Posted Date
- 2023-09-29
- Lead Sponsor
- Karolinska University Hospital
- Target Recruit Count
- 400
- Registration Number
- NCT06051045
- Locations
- 🇸🇪
Karolinska University Hospital, Department of Infectious Diseases, Stockholm, Sweden
Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy
- First Posted Date
- 2023-07-27
- Last Posted Date
- 2023-07-27
- Target Recruit Count
- 50
- Registration Number
- NCT05962307
- Locations
- 🇮🇹
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy., Milan, MI, Italy
HEllenic Multicenter ReAl-life CLInical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV
- First Posted Date
- 2023-07-03
- Last Posted Date
- 2023-07-03
- Lead Sponsor
- University of Athens
- Target Recruit Count
- 80
- Registration Number
- NCT05928000
- Locations
- 🇬🇷
Department of Gastroenterology, Medical School of National & Kapodistrian University of Athens, General Hospital of Athens "Laiko";, Athens, Greece
Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function
- First Posted Date
- 2023-03-13
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 72
- Registration Number
- NCT05765344
- Locations
- 🇺🇸
Clinical Pharmacology of Miami, LLC, Miami, Florida, United States
🇺🇸Texas Liver Institute, San Antonio, Texas, United States
🇺🇸University of Miami, Miami, Florida, United States
Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
- First Posted Date
- 2023-02-08
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 170
- Registration Number
- NCT05718700
- Locations
- 🇪🇸
Hospital Universitari Vall d'Hebrón, Barcelona, Spain
🇪🇸Hospital Clinic de Barcelona, Barcelona, Spain
🇪🇸Hospital Universitario Reina Sofía, Córdoba, Spain
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
- Conditions
- Interventions
- First Posted Date
- 2021-04-28
- Last Posted Date
- 2023-03-10
- Lead Sponsor
- Hannover Medical School
- Target Recruit Count
- 11
- Registration Number
- NCT04863703
- Locations
- 🇩🇪
Hannover Medical School, Hannover, Lower Saxony, Germany
Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
- Conditions
- Interventions
- First Posted Date
- 2019-02-25
- Last Posted Date
- 2024-10-08
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 175
- Registration Number
- NCT03852433
- Locations
- 🇷🇺
LLC Medical Company "Hepatolog", Samara, Russian Federation
🇷🇺Federal Budget Institute of Science "Central Research Institute for Epidemiology" of Federal Service on Consumers Rights Protection and Human Well-Being Surveillance, Moscow, Russian Federation
🇷🇺State Budgetary Educational Institution of Higher Professional Education "South Ural State Medical University" of the Ministry of Healthcare of the Russian Federation, Chelyabinsk, Russian Federation
Drug Development Updates
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