EFFicacy Optimization Research of Telbivudine Therapy (EFFORT)

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: telbivudine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00962533

MOH-01

Details and patient eligibility

About

The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

Enrollment: 606 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, from 18 (inclusive) to 65 (inclusive) years of age
• HBsAg and HBeAg positive for over six months
• Patient is willing and able to comply with the study drug regimen and all other study requirements
• Patients must give written informed consent before any assessment is performed

Exclusion criteria

• Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
• Patient has a history of or clinical signs/symptoms of hepatic decompensation
• Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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606 participants in 2 patient groups

ROADMAP Group (Group I)

Experimental group

Description:

Patients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load: * Group I-A: This group of patients was those with HBV DNA ≥300 copies/mL at Week 24 and adefovir was to be added at Week 28; * Group I-B: This group of patients was those with HBV DNA \<300 copies/mL at Week 24. Telbivudine monotherapy was to be continued until there was a viral breakthrough (confirmed by two examinations with at least 1 month interval with compliance factor excluded) and then adefovir was to be added; The total treatment duration was 104 weeks.

Treatment:

Drug: telbivudine

Drug: telbivudine

SOC (Standard of Care) Group (Group II)

Active Comparator group

Description:

patients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added.

Treatment:

Drug: telbivudine

Drug: telbivudine