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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

• Compare the safety of four oral doses of pradefovir after 48 weeks of treatment

• Select the dose of pradefovir for Phase 3 studies

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Adefovir; Adefovir dipivoxil; Pradefovir

Criteria

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