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Completed

NCT Number: NCT00962533

EFFicacy Optimization Research of Telbivudine Therapy

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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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

302 Military Hospital of China, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telbivudine

Drug

telbivudine, 600mg, oral, daily

Other names: Sebivo®

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

    Time frame: Week 104

Secondary outcomes

  1. Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52

    Time frame: week 52

  2. Serum HBV DNA reduction from baseline at week 104

    Time frame: week 104

  3. Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline

    Time frame: week 104

  4. Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline

    Time frame: week 104

  5. Serum HBV DNA reduction from baseline at week 52

    Time frame: week 52

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Major Science and Technology Special Project of China Eleventh Five-year
  • Novartis

Registry information

Official study title

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)

Acronym: EFFORT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2009
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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