Pradefovir and Adefovir and pradefovir mesylate in Hepatitis B, Chronic - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Hepatitis B, Chronic

Intervention / Treatment

Detailed Description

Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
Select the dose of pradefovir for Phase 3 studies
Determine the pharacokinetic profiles of four oral doses of pradefovir

Study Type

Interventional

Enrollment

220

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Safety: Clinical examinations of laboratory tests
- Efficacy: Change in viral load over time

Secondary Outcome Measures

Outcome Measure
- Efficacy: Proportion of patients with undetectable viral load

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria