NCT00230503

Brief Summary

  • Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
  • Select the dose of pradefovir for Phase 3 studies

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

Status
completed

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, 2004

Completed
1.3 years 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
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

2.5 years

First QC Date

September 28, 2005

Last Update Submit

June 21, 2012

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:

  • Compensated chronic HBV Infection
  • No prior treatment with adefovir dipivoxil
  • No interferon or lamivudine treatment for three months prior to enrollment
  • HBeAg positive or negative
  • HBV DNA viral load greater than 500,000 copies per mL
  • ALT between 1.2 and 10 times ULN

You may not qualify if:

  • Positive HIV, HCV, and/or HDV serology
  • History of renal tubular necrosis
  • Serum creatinine greater than 2.0 mg/dl
  • History of organ transplant or use of immunosuppresive drugs
  • Pregnant or breast-feeding females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gao Y, Kong F, Song X, Shang J, Yao L, Xia J, Peng Y, Liu W, Gong H, Mu M, Cui H, Han T, Chen W, Wu X, Yang Y, Yan X, Jin Z, Wang P, Zhu Q, Chen L, Zhao C, Zhang D, Jin W, Wang D, Wen X, Liu C, Jia J, Mao Q, Ding Y, Jin X, Zhang Z, Mao Q, Li G, Niu J. Pradefovir Treatment in Patients With Chronic Hepatitis B: Week 24 Results From a Multicenter, Double-Blind, Randomized, Noninferiority, Phase 2 Trial. Clin Infect Dis. 2022 Jun 10;74(11):1925-1932. doi: 10.1093/cid/ciab763.

    PMID: 34487151DERIVED

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
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, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 22, 2012

Record last verified: 2012-06