This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
AP-HP - Beaujon Hospital
Clichy, France
Hôpital Henri-Mondor
Créteil, France
Proportion of subjects with adverse events (AEs), premature treatment discontinuation and abnormal laboratory results.
Time frame: Through study completion, an average of 1.5 years.
Evaluating the change from baseline in HDV RNA & ALT levels
Time frame: Through study completion, an average of 1.5 years.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs and abnormal laboratory results.
Time frame: Through study completion, an average of 1.5 years.
Proportion of participants with undetectable HDV RNA or ≥2 log10 IU/mL reduction in HDV RNA
Time frame: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, the proportion of participants with normal ALT
Time frame: Through study completion, an average of 1.5 years.
Change from baseline in log10 HDV RNA
Time frame: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, the change from baseline in ALT
Time frame: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, proportion of participants with normal ALT
Time frame: Through study completion, an average of 1.5 years.
To characterize the PK of ABI-6250 in plasma in participants with cHDV
Time frame: Through study completion, an average of 1.5 years.
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CHU Lyon - Hôpital Croix-Rousse
Lyon, France
LLC Neolab
Tbilisi, Georgia
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliera Universitaria
Naples, Italy
Clinical Republican Hospital
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand
...and 12 more locations