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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00230490

Enrollment

150

Registered

2005-09-30

Start date

2005-06-30

Completion date

2007-05-31

Last updated

2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, Chronic, Hepatitis B Virus, Pradefovir Mesylate, Adefovir Dipivoxyl

Brief summary

Compare the long-term safety of pradefovir to adefovir dipivoxyl

Detailed description

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

Interventions

DRUGpradefovir mesylate

DRUGadefovir dipivoxyl

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
- Safety: Clinical examinations of laboratory tests	—
- Efficacy: Change in viral load over time	—

Secondary

Measure	Time frame
- Efficacy: Proportion of patients with undetectable viral load	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026