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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

October 29, 2009
June 20, 2013
September 2009
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01005238 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis, Chronic
  • Drug: Lamivudine
  • Drug: Telbivudine
  • Active Comparator: telbivudine
    patients in this arm will continue to take telbivudine
    Intervention: Drug: Telbivudine
  • Experimental: lamivudine
    patients in this arm will take lamivudine
    Intervention: Drug: Lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01005238
SASL28
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Markus Heim, Prof. University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP