Trial · NCT01438424
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Study entry to Week 192 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Study entry to Week 192 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay | Baseline to Week 192 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| PRIMARY | Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs | Continuously from Day 1 through Week 240 | All participants who received at least 1 dose of study drug in the current study. | Participants | NUMBER |
| SECONDARY | Overall Study: Mean HBV DNA Level by PCR Assay | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | log10 copies/mL | MEAN |
| SECONDARY | Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg) | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Percentage of Participants With HBeAg Seroconversion | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Overall Study: Mean Alanine Transaminase (ALT) Levels | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | U/L | MEAN |
| SECONDARY | Overall Study: Percentage of Participants Who Achieved ALT Normalization | Study entry to Week 216 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort) | Baseline to Week 192 | Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort) | Baseline to Week 192 | Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| PRIMARY | Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240 | Day 1 of treatment through Week 240 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Participants | NUMBER |
| PRIMARY | Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing | Day 1 of treatment through Week 240 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Participants | NUMBER |
| PRIMARY | Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing | Day 1 of treatment through Week 240 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Participants | NUMBER |
| SECONDARY | Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay | Baseline to Week 144 | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| PRIMARY | Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results | Continuously from Day 1 through Week 144 | Participants enrolled up to Week 144 who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort) | Baseline to Weeks 48, 96, 144, 192, and 240 | Participants enrolled from study AI463-022 who were nucleoside-naive, HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current study and were evaluable. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort) | Baseline to Weeks 48, 96, and 144 | Participants enrolled from study AI463-027 who were nucleoside-naive, HBeAg-negative and had \>60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort) | Baseline to Week 96 | Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants) | Percentage of participants | NUMBER |
| SECONDARY | Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort) | Baseline to Week 144 | Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants) | 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/NCT01438424/outcomes