NCT00962533|CompletedPhase 4DMC

EFFicacy Optimization Research of Telbivudine Therapy

EFFORT

A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)

Nanfang Hospital, Southern Medical University ClinicalTrials.gov

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1 other identifier

MOH-01

Study Type

interventional

Target

606

Locations

1 country

Sites

Timeline

RegisteredAug 2009

StartedAug 2009

CompletionAug 2012

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

606

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2009

Typical duration for phase_4

Geographic Reach

1 country

24 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

August 1, 2009

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed

Last Updated

January 31, 2013

Status Verified

March 1, 2012

Enrollment Period

2.7 years

First QC Date

August 18, 2009

Last Update Submit

January 29, 2013

Conditions

Hepatitis B, Chronic

Keywords

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II
Week 104

Secondary Outcomes (5)

Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
week 52
Serum HBV DNA reduction from baseline at week 104
week 104
Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
week 104
Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline
week 104
Serum HBV DNA reduction from baseline at week 52
week 52

Study Arms (2)

ROADMAP Group (Group I)

EXPERIMENTAL

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.

Drug: telbivudine

SOC (Standard of Care) Group (Group II)

ACTIVE COMPARATOR

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.

Drug: telbivudine

Interventions

telbivudineDRUG

telbivudine, 600mg, oral, daily

Also known as: Sebivo®

ROADMAP Group (Group I)

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.