Trial · NCT04535544
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 69
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind:Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach) | Week 48 | Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (\>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Primary | Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT at Week 48 (Multiple Imputation Approach) | Week 48 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Parts 1 and 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA < Lower Limits of Quantification (LLOQ) at Week 48 | Week 48 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA \< LLOQ at Week 48 was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Parts 1 and 2: Percentage of Participants With Normal ALT at Week 48 | Week 48 | Percentage of participants with normal ALT at Week 48 was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 48 | Week 48 | Percentage of participants with HBsAg seroclearance at Week 48 was reported. HBsAg seroclearance was defined as HBsAg negativity (quantitative HBsAg level \<LLOQ) based on the assay used. |
| Secondary | Parts 1 and 2: Percentage of Participants With >=2 Kilopascal (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) (FibroScan) at Week 48 | Week 48 | Percentage of participants with \>=2 kPa reduction from baseline in LSM assessed by VCTE (fibroscan) at Week 48 was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT | Week 48, FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT | Week 48, FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 1: Percentage of Participants With HDV RNA TND in Combination With Normal ALT | Week 48 and FU Week 24 | Percentage of participants with HDV RNA TND in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. TND was defined as no traces of HBV RNA were detected/found. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Part 2: Percentage of Participants With HDV RNA TND in Combination With Normal ALT | Week 48 and FU Week 24 | Percentage of participants with HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 1: Percentage of Participants With HDV RNA TND | Week 48, FU Week 24 | Percentage of participants with HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found. |
| Secondary | Part 2: Percentage of Participants With HDV RNA TND | Week 48, FU Week 24 | Percentage of participants with HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found. |
| Secondary | Part 1: Percentage of Participants With Normal ALT | FU Week 24 | Percentage of participants with Normal ALT was reported. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. |
| Secondary | Part 2: Percentage of Participants With Normal ALT | FU Week 24 | Percentage of participants with Normal ALT was reported. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. |
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
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GET https://conductscience.org/api/trials/v1/NCT04535544/registered