Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

Bausch Health Americas, Inc.220 enrolled

Overview

* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment * Select the dose of pradefovir for Phase 3 studies

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Hepatitis B, Chronic

Interventions

pradefovir mesylateDRUG

adefovir dipivoxylDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

- Safety: Clinical examinations of laboratory tests

- Efficacy: Change in viral load over time

Secondary Outcomes

- Efficacy: Proportion of patients with undetectable viral load

Data from ClinicalTrials.gov

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