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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00230490
• Other study ID #: RNA200103-202
• Status: Terminated
• Phase: Phase 2
• 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
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

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