NCT00230490

Brief Summary

Compare the long-term safety of pradefovir to adefovir dipivoxyl

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

First QC Date

September 28, 2005

Last Update Submit

November 26, 2019

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, ChronicHepatitis B VirusPradefovir MesylateAdefovir Dipivoxyl

Outcome Measures

Primary Outcomes (2)

  • - Safety: Clinical examinations of laboratory tests

  • - Efficacy: Change in viral load over time

Secondary Outcomes (1)

  • - Efficacy: Proportion of patients with undetectable viral load

Interventions

pradefovir mesylateDRUG
adefovir dipivoxylDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

pradefovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ralph T. Doyle

    Bausch Health Americas, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

June 1, 2005

Study Completion

May 1, 2007

Last Updated

November 29, 2019

Record last verified: 2019-11