EFFicacy Optimization Research of Telbivudine Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ROADMAP Group (Group I)

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.

Group Type EXPERIMENTAL

telbivudine

Intervention Type DRUG

telbivudine, 600mg, oral, daily

SOC (Standard of Care) Group (Group II)

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.

Group Type ACTIVE_COMPARATOR

telbivudine

Intervention Type DRUG

telbivudine, 600mg, oral, daily

Interventions

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telbivudine

telbivudine, 600mg, oral, daily

Intervention Type DRUG

telbivudine

telbivudine, 600mg, oral, daily

Intervention Type DRUG

Other Intervention Names

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Sebivo® Sebivo®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinlin Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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