The primary objective of this study is to evaluate the efficacy of bulevirtide in combination with pegylated interferon in participants with chronic hepatitis delta (CHD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
175
Administered via subcutaneous injections
Administered via subcutaneous injections
Hôpital Beaujon-Pavillon Abrami -Sce Hépatologie
Clichy, France
Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24)
SVR24 was defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 24 weeks after the scheduled end of treatment (EOT).
Time frame: 24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D)
Percentage of Participants With Undetectable HDV RNA at Week 48
Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48.
Time frame: Week 48
Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only)
Undetectable HDV RNA at Week 96 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 96.
Time frame: Week 96
Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment
Combined response was defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, alanine aminotransferase (ALT) normalization, defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).
Time frame: 24 weeks after EOT (Week 72 for Arm A and Week 120 for Arms B, C, and D)
Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment
Combined response is defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, ALT normalization, defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France
Hospital Croix Rousee
Lyon, France
Hôpital Saint Joseph Hépato-Gastroentérologie
Marseille, France
CH Pitié-Salpétrière - Hépato-Gastroentérologie
Paris, France
Hôpital Cochin - Unité d'Hépatologie Pavillon Achard
Paris, France
Infectious Clinical Hospital "T. Ciorba", Department 4 / Medical University Department of Infectious Diseases
Chisinau, Moldova
Infectious Clinical Hospital "T. Ciorba", Department 5 / Medical University Department of Infectious Diseases
Chisinau, Moldova
"Matei Bals" National Institute of Infectious Diseases, Hospital department
Bucharest, Romania
"Matei Bals" National Institute of Infectious Diseases,Clinical Trials department
Bucharest, Romania
...and 10 more locations
Time frame: 48 weeks after EOT (Week 96 for Arm A and Week 144 for Arm B, C, and D)
Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48)
SVR 48 is defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 48 weeks after the scheduled end of treatment.
Time frame: 48 weeks after EOT (Week 96 for Arm A; Week 144 for Arms B, C, and D)
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48
The mixed-effects models for repeated measurements (MMRM) model was used for analysis.
Time frame: Baseline, Week 48
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96
The MMRM model was used for analysis.
Time frame: Baseline, Week 96
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144
The MMRM model was used for analysis.
Time frame: Baseline, 48 weeks after EOT (Week 96 for Arm A and study Week 144 for Arms B, C, and D)