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Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

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Bausch Health

Status and phase

Terminated
Phase 2

Conditions

Hepatitis B, Chronic

Treatments

Drug: adefovir dipivoxyl
Drug: pradefovir mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00230490
RNA200103-202

Details and patient eligibility

About

Compare the long-term safety of pradefovir to adefovir dipivoxyl

Full description

  • Compare the long-term safety of pradefovir to adefovir dipivoxyl
  • Monitor development of resistance
  • Evaluate virologic and biochemical response

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who completed 48 weeks of treatment in study RNA200103-201

Exclusion criteria

  • Patients who were determined to be treatment failures in study RNA200103-201
  • Patients who experienced a serious adverse event judged to be related to study drug in study RNA200103-201
  • Patients with a serum creatinine greater than 2.0 mg/dl on two consecutive determinations in study RNA200103-201

Trial design

Primary purpose

Treatment

Allocation

Non-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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