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Completed

NCT Number: NCT00230503

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

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

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pradefovir mesylate

Drug

adefovir dipivoxyl

Drug

Primary outcomes

  1. - Safety: Clinical examinations of laboratory tests

  2. - Efficacy: Change in viral load over time

Secondary outcomes

  1. - Efficacy: Proportion of patients with undetectable viral load

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 30, 2005
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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