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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

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

Phase: Phase 3

Status: Terminated

Sponsored by: Novartis

Summary

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.

Clinical Details

Official title: A Randomized, Open-label, Controlled, Multi-center Two-year Study Comparing Efficacy and Safety of Telbivudine, 600 mg PO in Combination With Peginterferon Alpha-2a sq 180 g With Peginterferon Alpha-2a Monotherapy, and With Telbivudine Monotherapy in Treatment nave Patients With HBeAg-positive CHB.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy

Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB)

Secondary outcome:

Change From Baseline in HBV DNA Concentration

Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52

Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion

Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy

Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Novartis, San Francisco, California 94115, United States
Additional Information

Starting date: December 2006
Last updated: June 14, 2011

Page last updated: August 23, 2015

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