Status:
COMPLETED
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00230503
Start Date
June 1 2004
End Date
December 1 2006
Last Update
June 22 2012
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