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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00230490
Other study ID # RNA200103-202
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 2005
Est. completion date May 2007

Study information

Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare the long-term safety of pradefovir to adefovir dipivoxyl


Description:

- Compare the long-term safety of pradefovir to adefovir dipivoxyl

- Monitor development of resistance

- Evaluate virologic and biochemical response


Recruitment information / eligibility

Status Terminated
Enrollment 150
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
pradefovir mesylate

adefovir dipivoxyl


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary - Safety: Clinical examinations of laboratory tests
Primary - Efficacy: Change in viral load over time
Secondary - Efficacy: Proportion of patients with undetectable viral load
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