Trial · NCT01480284
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Serum HBV DNA Level at Week 24 | Baseline and Week 24 | The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | Baseline, Week 48 and Week 96 | The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | Week 24, Week 48 and Week 96 | The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated HBsAg category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, and \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized. The LOCF method was applied for missing values. |
| Secondary | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg \<3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and \>=6.0) (Log kilo unit per liter \[KU/L\]) by study visit was summarized. The LOCF method was applied for missing values. |
| Secondary | Number of Participants With Virological Breakthrough Through End of the Study | From Baseline to throughout study | The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase \>=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit. |
| Secondary | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study) | The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (\< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered "Negative" in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit. |
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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