Tenofovir versus Adefovir for the treatment of HBeAg negative chronic hepatitis B

A randomised, phase III, double blind study to evaluate the efficacy and safety of tenofovir DF versus adefovir dipivoxil in the treatment of presumed pre-core mutant chronic hepatitis B to suppress viral replication, amend the course of the disease and decrease morbidity.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000029695

Acronym

GS-US-174-0102

Enrollment

300

Registered

2005-07-22

Start date

2005-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

To compare the efficacy of tenofovir DF 300 mg versus adefovir dipivoxil 10mg for the treatment of presumed pre-core mutany chronic hepatitis B over 48 weeks of treatment

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Healthy volunteers

Inclusion criteria

Adult patients (18-69 years of age) with presumed pre-core mutant chronic hepatitis B (HBsAg negative and HBsAg positive), HBsAg positive for more than 6 months with serum HBV DNA >10 to the 5 copies /mL, ALT levels >1.5 and less than or equal to 10x ULN and a Knodell necroinflammatory score of greater than or equal to 3 and a Knodell fibrosis score equal to 4 will be eligible for enrollment. However, up to 120 patients with cirrhosis, i.e. knodell fibrosis score equal to 4, will be eligible for enrollment. Patients who have not had a bopisy within 6 months at baseline must agree to undergo a liver biopsy prior to randomisation. No evidence of hepatocellular carcinoma (HCC) ie. fetoptotein < 50 ng/mL at screening. Patients are eligible if they are treatment naive, ie less than 12 weeks of prior nucleoside or nucleotide (adefovir, dipivoxil or tenofovir DF) treatment, or with prior lamivudine experience of any duration. Enrollment of lamivudine experienced patients will be capped at up to 40% of the patient population (ie120 patients). Any previous treatment with nucleosides and nucleotides (eg up to 12 weeks) and interferon (pegylated or not) must have ended at least 6 months prior to the pre-treatment biopsy.

Exclusion criteria

Patients must be without HIV, HCV and HDV infection. Pregnant and breast feeding women will be excluded from the study and patients with decompensated liver disease or a history of decompensated liver disease (ascites, jaundice, encephalopathy or variceal haemorrhage) will be excluded from the study.

Outcome results