Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
NCT00230503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2012-06-22
Summary
* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies
Conditions
- Hepatitis B, Chronic
Interventions
- DRUG
-
pradefovir mesylate
- DRUG
-
adefovir dipivoxyl
Sponsors & Collaborators
-
Bausch Health Americas, Inc.
lead INDUSTRY
Principal Investigators
-
Ralph T. Doyle · Bausch Health Americas, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Primary Completion
- 2006-12-31
- Completion
- 2006-12-31
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