Hepatitis B, Chronic
Conditions
Keywords
Hepatitis B, Chronic, Hepatitis B Virus, Pradefovir Mesylate, Adefovir Dipivoxyl
Brief summary
* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment * Select the dose of pradefovir for Phase 3 studies
Detailed description
* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment * Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment * Select the dose of pradefovir for Phase 3 studies * Determine the pharacokinetic profiles of four oral doses of pradefovir
Interventions
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Compensated chronic HBV Infection * No prior treatment with adefovir dipivoxil * No interferon or lamivudine treatment for three months prior to enrollment * HBeAg positive or negative * HBV DNA viral load greater than 500,000 copies per mL * ALT between 1.2 and 10 times ULN
Exclusion criteria
* Positive HIV, HCV, and/or HDV serology * History of renal tubular necrosis * Serum creatinine greater than 2.0 mg/dl * History of organ transplant or use of immunosuppresive drugs * Pregnant or breast-feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety: Clinical examinations of laboratory tests | — |
| - Efficacy: Change in viral load over time | — |
Secondary
| Measure | Time frame |
|---|---|
| - Efficacy: Proportion of patients with undetectable viral load | — |
Outcome results
None listed