Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: tenofovir disoproxil fumarate; Drug: telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01379508

CLDT600A2409

2007-000180-13 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 <10×ULN at screening visit; patient with normal ALT ≤1xULN at screening are eligible, with moderate liver inflammation or fibrosis, complensated liver sirrhosis, ALT level >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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 2 patient groups

telbivudine

Experimental group

Description:

telbivudine 600 mg tablet orally (p.o.) once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with tenofovir 300 mg tablets p.o. once daily for the remaining weeks of treatment. The investigator was to initiate tenofovir add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA \< 300 copies/mL at Week 24 were to continue to receive telbivudine monotherapy

Treatment:

Drug: telbivudine

tenofovir

Active Comparator group

Description:

tenofovir 300 mg tablets p.o. once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with telbivudine 600 mg tablet p.o. once daily for the remaining weeks of treatment. The investigator was to initiate telbivudine add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA \< 300 copies/mL at Week 24 were to continue to receive tenofovir monotherapy

Treatment:

Drug: tenofovir disoproxil fumarate