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)

University Hospital Basel

Status and phase

Terminated

Phase 4

Conditions

Hepatitis, Chronic

Treatments

Drug: Telbivudine

Drug: Lamivudine

Study type

Interventional

Funder types

Other

Identifiers

NCT01005238

SASL28

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.