Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03852719
Other study ID # MYR301
Secondary ID 2019-001213-17
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 17, 2019
Est. completion date July 2024

Study information

Verified date September 2023
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of bulevirtide for treatment of chronic hepatitis delta (CHD) in comparison to delayed treatment.


Read more »

Study Design


Intervention

Drug:
Bulevirtide
Administered via SC injections

See more »

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Russian Federation,  Sweden, 

References & Publications (5)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Combined Response at Week 48 Combined response was defined as fulfilment of two conditions simultaneously: Undetectable (< lower limit of quantification (LLOQ, target not detected)) HDV RNA or decrease by = 2 log10 IU/mL from baseline; and ALT normalization. Week 48
Secondary Percentage of Participants With Undetectable HDV RNA at Week 48 Week 48
Secondary Percentage of Participants With Alanine Aminotransaminase (ALT) Normalization at Week 48 ALT normalization was 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]) Week 48
Secondary Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 Baseline, Week 48
Secondary Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) (Week 48) An AE was defined as any untoward medical occurrence in a participant administered study drug and which did not necessarily had a causal relationship with the study drug. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. First dose date up to Week 48
Secondary Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) (Week 96) An AE was defined as any untoward medical occurrence in a participant administered study drug and which did not necessarily had a causal relationship with the study drug. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. Delayed Treatment arm: Week 48 up to Week 96; Bulevertide 2mg/day and 10 mg/day arms: First dose date up to Week 96
Secondary Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) (Week 144) An AE was defined as any untoward medical occurrence in a participant administered study drug and which did not necessarily had a causal relationship with the study drug. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. First dose date up to Week 144.
Secondary Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) Week 168
Secondary Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) Week 192
Secondary Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96 A mixed-effects model for repeated measures (MMRM) was used to test null hypotheses of no difference compared to the control group. Change from baseline in liver stiffness was the dependent variable using data for all post-baseline analysis visits up to Week 96. The model included treatment, region, presence of cirrhosis, visit and treatment-by-visit interaction as fixed-effect factors, and baseline Liver stiffness as covariate Baseline, Week 96
Secondary Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144 Baseline, Week 144
Secondary Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192 Baseline, Week 192
Secondary Change From Baseline in Liver Stiffness, as Measured by Elastography at Weeks 240 Baseline, Week 240
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04170452 - Study the Content of the HBV DNA in Liver Biopsy in the Patients Chronic Hepatitis Delta
Completed NCT03852433 - Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD) Phase 2
Withdrawn NCT05953545 - Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis Phase 2

External Links