E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008910 |
E.1.2 | Term | Chronic hepatitis B |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study was to evaluate the antiviral efficacy of Telbivudine with percentage of patients achieving HBV DNA<300 copies/mL at week 52. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study were as follows:
1. To assess percentage of patients achieving HBV DNA<300 copies/mL at Week 24.
2. To assess the reduction in HBV DNA from baseline at Weeks 12, 24, 36 and 52.
3. To assess percentage of patients with HBeAg loss / seroconversion at Week 52 in HBeAg positive patients at baseline.
4. To assess percentage of patients with ALT normalization at Weeks 24 and 52 in patients with elevated ALT at baseline.
5. To assess percentage of patients with HBsAg loss / seroconversion at Week 52.
6. To assess percentage of patients with virologic breakthrough at Week 52.
7. To assess percentage of patients with treatment-emergent genotypically confirmed resistance associated with virologic breakthrough at Week 52.
8. To assess the safety endpoints, including incidence of clinical adverse events and graded laboratory abnormalities at Week 52. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male or female 16 to 65 year of age
•Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
•Willing and able to comply with the study drug regimen
•Written informed consent before any assessment
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E.4 | Principal exclusion criteria |
•Patient has a history of/or clinical signs/symptoms of hepatic decompensation
•Patient has a history of HCC or findings suggestive of possible HCC
•Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
•History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
•Patient has received IFN or other immunomodulatory treatment with 12 months before screening
•Previous treatment history with NRTIs
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E.5 End points |
E.5.1 | Primary end point(s) |
HBV DNA PCR negativity rate |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) HBV DNA PCR negativity rate
2) DNA reduction
3) HBeAg loss rate
4) HBeAg seroconversion rate
5) ALT normalization rate
6) Incidence of AE (SAE,etc), Graded lab abnormalities |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) At week 24
2) From baseline to weeks 12, 24, 36, 52
3) At week 52
4) At week 52
5) At weeks 24 and 52
6) At week 52 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined by reaching the last patient last visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 16 |