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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Terminated

CT.gov ID

NCT01005238

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatitis, Chronic	Drug: Lamivudine Drug: Telbivudine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [The primary efficacy endpoint is the rate of viral breakthrough at week 108.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.