Trial · NCT00065507
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24 | Baseline, Week 24 | Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis. |
| Secondary | Change From Baseline in HBV DNA by PCR at Week 48 | Baseline, Week 48 | Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status. |
| Secondary | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24 | Week 24 | |
| Secondary | Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48 | Week 48 | |
| Secondary | Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48 | Week 24, Week 48 | Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal \[ULN\]) among those with baseline ALT \>1.0 x ULN at Weeks 24 and 48 |
| Secondary | Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | |
| Secondary | >=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). |
| Secondary | Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). |
| Secondary | Change From Baseline in Child-Pugh Score Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). |
| Secondary | Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48 | Week 24, Week 48 | Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C. |
| Secondary | Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; \<10=4% mortality. |
| Secondary | Improvement or No Worsening in MELD Score Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 | Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; \<10=4% mortality. |
| Secondary | Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36) | Baseline, Week 24, Week 48 | Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group. |
| Secondary | Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48 | Baseline, Week 24, Week 48 | The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group. |
| Secondary | Change From Baseline in Albumin Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL. |
| Secondary | Mean Change From Baseline in Prothrombin Time Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds. |
| Secondary | Mean Change From Baseline in Total Bilirubin Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL. |
| Secondary | Change From Baseline in Platelet Count Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10\*9 c/L. |
| Secondary | Participants Achieving Albumin Normalization Through Week 48 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | Number of participants who achieved normalization of albumin (\>= 1 x lower limit of normal \[LLN\]), a measure of liver function, at specific timepoints. |
| Secondary | Participants Achieving Prothrombin Time Normalization Through Week 48 | Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48 | Number of participants who achieved normalization of prothrombin time (\<= 1 x ULN), a measure of liver function, at specific timepoints. |
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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