Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 11 of 11

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Combined Response at Week 48	Week 48	The Full Analysis Set included participants randomized to delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Undetectable HDV RNA at Week 48	Week 48	Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48	Week 48	Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48	Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 48	Participants in the Full Analysis Set with available data were analyzed. Data is reported separately for changes from Baseline at Week 48 for the Delayed Treatment arm and for Delayed Treatment/Bulevirtide 10 mg/day arm after 48 weeks of bulevirtide 10 mg treatment. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.	kPa	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96	Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 96	Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.	kPa	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144	Baseline, Week 144	Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.	kPa	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192	Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 192	Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.	kPa	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240	Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 240	Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.	kPa	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response)	Week 168	Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response)	Week 192	Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event (AE) by Week 144	Delayed Treatment/Bulevirtide 10 mg/day arm: Week 48 up to Week 144; Bulevirtide 2mg/day and 10 mg/day arms: First dose date up to Week 144	Participants in the SAS were analyzed. The SAS included all participants who were randomized into the study and took at least 1 dose of bulevirtide study drug, or who were randomized to the delayed treatment group. Participants were grouped according to actual treatment received for time points Week 0 to 144. The arm titles and descriptions in this outcome measure are entered accordingly.	percentage of participants	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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GET https://conductscience.org/api/trials/v1/NCT03852719/outcomes

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