Phase 4
Completed N=241
Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
Source: ClinicalTrials.gov NCT01379508 ↗Enrolled (actual)
241
Serious AEs
10.0%
Results posted
Nov 2018
Primary outcomePrimary: Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) - — 91.0; 95.0; 91.9; 95.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) - |
91.0; 95.0; 91.9; 95.0; 95.4; 99.2 | — |
| SECONDARY Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT) |
98.9; 0.0; 80.5; 99.1; 0; 89.7 | — |
| SECONDARY Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT) |
17.7; 11.8; 16.5; 13.9; 20.0; 14.6 | — |
| SECONDARY eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study |
1.43; -12.06; -1.07; -2.41; -7.17; -2.85 | — |
Eligibility Criteria
Inclusion Criteria
Male or female, at least 18 years of age
Documented compensated HBeAg negative CHB defined by all of the following:
- Detectable serum HBsAg at screening visit and at least 6 months prior;
- HBeAg negative at the screening visit with positive HBeAb;
- Serum HBV DNA > 2000 IU/mL Serum ALT level > 1×ULN and 1xULN wtihin last 6 months
Exclusion Criteria
- Co-infected with HCV, HDV or HIV.
- Received treatment of nucleoside or nucleotide drugs at any time
- Received IFN or other immunomodulatory treatment within six months before Screening
- Pregnant or nursing (lactating) women
- Clinical signs/symptoms of hepatic decompensation
- History of myopathy, myositis or persistent muscle weakness
- history of clinical and laboratory evidence of chronic renal insufficency
Data sourced from ClinicalTrials.gov (NCT01379508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.