Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine (SASL28)

This study has been terminated.
(unsufficient patient recruitment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01005238
First received: October 29, 2009
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.


Condition Intervention Phase
Hepatitis, Chronic
Drug: Lamivudine
Drug: Telbivudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open Label Study Evaluating the Efficacy of Continuous Telbivudine Versus Lamivudine in Patients With HBeAg-negative Chronic Hepatitis B Who Had Previously Achieved an Undetectable Viral Load During 24 Weeks of Telbivudine Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL. [ Time Frame: The primary efficacy endpoint is the rate of viral breakthrough at week 108. ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: telbivudine
patients in this arm will continue to take telbivudine
Drug: Telbivudine
Experimental: lamivudine
patients in this arm will take lamivudine
Drug: Lamivudine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, > 18 (having completed their 18th birthday). There is no upper limit of age
  • Documented HBeAg negative CHB
  • HBsAg positive > 6 months
  • HBV DNA > 2000 IU/mL
  • Patient is willing and able to comply with the study drug regimen and all other study requirements.
  • Written informed consent
  • Anti-viral HBV treatment naïve or previous treatment with interferon-alpha or pegylated interferon-alpha stopped at least 1 month prior to screening

Exclusion Criteria:

  • Decompensated liver cirrhosis according to the judgment of the local investigator
  • Hepatocellular carcinoma
  • History of or laboratory signs of co-infection with HIV or HCV, HDV
  • Previous treatment with anti-viral drugs (previous treatment with interferon-α or pegylated interferon-α is not an exclusion criteria, but has to be stopped one month before screening)
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients
  • Any medical condition that requires frequent or prolonged use of systemic corticosteroids (inhaled, topic or intra-articular corticosteroids are allowed)
  • Any medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
  • Current abuse of alcohol or illicit drugs.
  • Use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • Any other concurrent medical or social condition which is, in the opinion of the investigator, likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
  • Any of the following laboratory values during Screening:

    • Hemoglobin (HGB) <11 g/dL for men or <10 g/dL for women
    • Total WBC <3000/mm3
    • Absolute neutrophil count (ANC) <1,500.mm3
    • Platelet count <50'000/mm3
    • Serum amylase or lipase ≥ 1.5 x ULN
    • Serum albumin <3 g/dL
    • Total bilirubin > 51 μmol/L (> 3.0 mg/dL)
    • Estimated calculated serum creatinine clearance < 50 mL/min using the Cockcroft-Gault method using actual or ideal body weight whichever is less (Cockcroft and Gault 1976)
    • AFP (alpha-fetoprotein) > 100 ng/mL
    • ALT > 10x ULN
  • Women who are pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) during Screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005238

Locations
Switzerland
University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Markus Heim, Prof. University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01005238     History of Changes
Other Study ID Numbers: SASL28
Study First Received: October 29, 2009
Last Updated: June 20, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Lamivudine
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 31, 2014