Trial · NCT03852719
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Combined Response at Week 48 | 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. |
| Secondary | Percentage of Participants With Undetectable HDV RNA at Week 48 | Week 48 | Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48. |
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Week 48 | ALT normalization was defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]) |
| 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 | ANCOVA was used for analysis. |
| 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 | Mixed model for repeated measurements (MMRM) was used for analysis. |
| Secondary | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144 | Baseline, Week 144 | MMRM was used for analysis. |
| 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 | MMRM was used for analysis. |
| 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 | MMRM was used for analysis. |
| Secondary | Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 168 | Undetectable HDV RNA 24 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 168 |
| Secondary | Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 192 | Undetectable HDV RNA 48 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 192 |
| 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 | An AE was defined as any untoward medical occurrence in a participant administered study drug and which did not necessarily have 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. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03852719/registered