Trial · NCT01204762
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion | 24 weeks post-dosing (Week 72) | |
| Primary | Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events | Week 24 | |
| Primary | Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events | 24 weeks post-dosing (Week 72) | |
| Primary | Part B: Safety and tolerability of Lambda/ETV regimen as measured by the frequency of SAEs and discontinuations due to AEs | Up to 84 Weeks | |
| Secondary | Part A: Proportion of subjects who achieve an hepatitis B virus Deoxyribonucleic acid levels (HBV DNA) < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - High Pure System (HPS) assay | Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Mean change from baseline in log10 HBV DNA levels over time (Proportion of subjects with Alanine amino transferase (ALT) normalization (≤ 1 x upper limit of normal (ULN)) | Baseline (Day 1), Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Proportion of subjects with ALT normalization (≤ 1 x ULN) | Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Hepatitis E antigen (HBeAg) loss | Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: HBeAg seroconversion | Weeks 24, 48, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Mean change from baseline in log10 quantitative HBeAg levels over time | Baseline (Day 1), Weeks 24, 48, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Number and percent of subjects with adverse events (AEs) or laboratory abnormalities | Up to Week 24 | |
| Secondary | Part A: Number and percent of subjects with adverse events (AEs) or laboratory abnormalities | Up to Week 72 | |
| Secondary | Part A: Pharmacokinetic (PK) parameter Maximum observed concentration (Cmax) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data | Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48 | |
| Secondary | Part A: Pharmacokinetic (PK) parameter Time of maximum observed concentration (Tmax) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data | Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48 | |
| Secondary | Part A: Pharmacokinetic (PK) parameter Trough serum concentration pre-dose (C0) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data | Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48 | |
| Secondary | Part A: PK parameter serum concentration 168 hours post observed dose [Cmin] (C0 will be used as an estimate of Cmin if sample is not collected) of pegIFNλ will be derived from serum concentration versus time data | Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48 | |
| Secondary | Part A: PK parameter Area under the concentration-time curve in 1 dosing interval from time 0 to 168 hours post observed dose [AUC(TAU)] of pegIFNλ will be derived from serum concentration versus time data | Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48 | |
| Secondary | Part A: PK parameter Accumulation index (AI) ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (only conducted if data warrant) of pegIFNλ will be derived from serum concentration versus time data | Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48 | |
| Secondary | Part B: HBeAg seroconversion rate at 24 weeks off treatment | Week 84 | |
| Secondary | Part B: Antiviral activity of Lambda/ETV regimen, as determined by the proportion of subjects who achieve an HBV DNA < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - HPS assay | Weeks 4, 8, 12, 24, 36, 60, and 84 |
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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