A Two-year Study of Telbivudine in HBeAg Negative Hepatitis (STEN)

This study is currently recruiting participants.
Verified January 2012 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Collaborators:
Guangdong Provincial People's Hospital
Guangzhou 8th People's Hospital
Information provided by (Responsible Party):
Chao-Shuang Lin, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01521975
First received: January 26, 2012
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes adding ADV treatment at different time points according to individual patient response. China CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP strategy particularly, which may be a large potential to expand the naïve patients. We are lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log showed a good 2 year efficacy, but we still look forward to more efficient treatment and lower resistance rate. This study complies with the principle of individualized therapy recommended and ethical principles. It is expected that this study design with individualized treatment approach may improve efficacy and lower the resistance rates. In addition, it will provide important information on how to bring greater benefits to patients with CHB.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: Telbivudine, Adefovir dipivoxil
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-year, Open-label, Virological Response Adaptive Design, Multicenter Study to Evaluate Efficacy of Telbivudine in HBeAg Negative Adult CHB Patients With Roadmap Strategy

Resource links provided by NLM:


Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • To demonstrate the percentage of patients undectable HBV DNA [ Time Frame: at Week 104 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 360
Study Start Date: September 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBeAg Negative Hepatitis Drug: Telbivudine, Adefovir dipivoxil
All patients will take Sebivo 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding ADV.
Other Name: Sebivo, LDT

Detailed Description:

This study is an open-label, multicenter, PCR response adaptive clinical study design, with intensification of treatment (addition of adefovir to telbivudine treatment) depending on HBV DNA level at week 24. All patients commence with Telbivudine 600mg daily. At week 24 they will be divided into 2 Groups according to virological response. Patients with PCR detectable HBV DNA will add on ADV(Group I). Patients with PCR undetectable HBV DNA(Group II)will continue telbivudine monotherapy. ADV will not be added on unless viral breakthrough occurs.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Detectable serum HBsAg at the Screening visit and at least 6 months prior
  • HBeAg negative at Screening visit
  • serum HBV DNA level >2,000 IU/mL at Screening visit
  • Elevated serum ALT≥2 ×ULN and <10×ULN at Screening visit (excluding ALT elevations due to non-HBV reasons such as drug, alcohol etc)

Exclusion Criteria:

  • Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
  • Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)>50ng/mL.
  • Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
  • Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
  • Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
  • Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
  • Patient has used hepatotoxic drugs within one month.
  • Patient has overtaken alcohol (>40g/day) or abused illicit drugs in recent one year.
  • Use of other investigational drugs at the time of enrollment.
  • History of hypersensitivity to any of the study drugs (telbivudine or adefovir).
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
  • Patient is co-infected with HCV, HDV or HIV.
  • Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis).
  • History of malignancy of any organ system.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521975

Locations
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Chao-Shuang Lin, Doctor    0086(020)85252110    linchaoshuang@yahoo.com.cn   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Guangzhou 8th People's Hospital
Investigators
Principal Investigator: Zhi-Liang Gao, Prof Third Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Chao-Shuang Lin, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01521975     History of Changes
Other Study ID Numbers: HBeAg negative Roadmap
Study First Received: January 26, 2012
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
HBV DNA
LdT
ADV
HBeAg negative hepatitis
CHB

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 17, 2014