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

Primary Purpose

Hepatitis B, Chronic

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

pradefovir mesylate

adefovir dipivoxyl

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B, Chronic, Hepatitis B Virus, Pradefovir Mesylate, Adefovir Dipivoxyl

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

- Safety: Clinical examinations of laboratory tests

- Efficacy: Change in viral load over time

Secondary Outcome Measures

- Efficacy: Proportion of patients with undetectable viral load

Full Information

NCT ID

NCT00230490

First Posted

September 28, 2005

Last Updated

November 26, 2019

Sponsor

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00230490

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

Adverse findings from nonclinical carcinogenicity studies.

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch Health Americas, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

pradefovir mesylate

Intervention Type

Drug

Intervention Name(s)

adefovir dipivoxyl

Primary Outcome Measure Information:

Title

- Safety: Clinical examinations of laboratory tests

Title

- Efficacy: Change in viral load over time

Secondary Outcome Measure Information:

Title

- Efficacy: Proportion of patients with undetectable viral load

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph T. Doyle

Organizational Affiliation

Bausch Health Americas, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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