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

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Bausch Health

Status and phase

Completed
Phase 2

Conditions

Hepatitis B, Chronic

Treatments

Drug: pradefovir mesylate
Drug: adefovir dipivoxyl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00230503
RNA200103-201

Details and patient eligibility

About

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

Full 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 treatment
  • Select the dose of pradefovir for Phase 3 studies
  • Determine the pharacokinetic profiles of four oral doses of pradefovir

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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