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Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)

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Novartis

Status and phase

Terminated
Phase 3

Conditions

Hepatitis B

Treatments

Drug: peginterferon alpha-2a
Drug: Telbivudine (LdT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00412750
CLDT600A2406

Details and patient eligibility

About

To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.

Enrollment

159 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented Chronic hepatitis B (CHB) defined by all of the following:

  • Clinical history compatible with CHB
  • Detectable serum Hepatitis B Surface Antigen (HBsAg) at the Screening visit and at least 6 months prior
  • HBeAg-positive at the Screening visit
  • Hepatitis B 'e' Antibody (HBeAb)-negative at the Screening visit
  • History of evidence of chronic liver inflammation,
  • Elevated serum Alanine aminotransferase (ALT) level (1.3 - 10 x upper limit of normal (ULN)) at the Screening visit
  • Serum HBV DNA level ≥ 6 log10 copies/mL,
  • Chronic liver inflammation on previous liver biopsy within the previous 24 months.

Exclusion criteria

  • Co-infection with Hepatitis C Virus (HCV), Hepatitis D Virus (HDV), or Human Immunodeficiency Virus (HIV).

  • Has any of the following drug therapy:

    • Previously been treated in a trial with telbivudine
    • Received nucleoside or nucleotide therapy whether approved or investigational
    • Received any immunomodulatory treatment in the 12 months before Screening for this study.
    • Has a medical condition that required prolonged or frequent use of systemic acyclovir or famciclovir.
    • Has a medical condition that requires frequent or prolonged use of systemic corticosteroids although inhaled or intra-articular corticosteroids are allowed.
    • Has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
    • Is currently abusing alcohol or illicit drugs or has a history of alcohol abuse illicit substance abuse within the preceding two years.
    • Uses other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
    • Is currently receiving methadone.
  • Patient has any of the following:

    • History of or clinical signs/symptoms of hepatic decompensation such as ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
    • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with previous findings suggestive of possible HCC should have the disease ruled out prior to entrance into the study.
    • One or more additional known primary or secondary causes of liver disease other than hepatitis B, including steatohepatitis.
    • History of clinical and laboratory evidence of chronic pancreatitis, or demonstrates a clinical and laboratory course consistent with current pancreatitis.
  • Has laboratory values during screening visit not within normal limits.

  • Is pregnant or breastfeeding.

  • Is a women of child-bearing potential that is unwilling to practice birth control.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

159 participants in 3 patient groups

LdT+ PEG-INF
Experimental group
Description:
Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peginterferon alpha-2a (PEG-INF)180 μg subcutaneous injection once a week for 52 weeks.
Treatment:
Drug: Telbivudine (LdT)
Drug: peginterferon alpha-2a
LdT Monotherapy
Experimental group
Description:
Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
Treatment:
Drug: Telbivudine (LdT)
PEG-INF Monotherapy
Active Comparator group
Description:
Peginterferon alpha-2a (PEG- INF) monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
Treatment:
Drug: peginterferon alpha-2a

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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