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Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pradefovir mesylate
adefovir dipivoxyl
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Outcomes
Full info

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: 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

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

    First Posted
    September 28, 2005
    Last Updated
    June 21, 2012
    Sponsor
    Bausch Health Americas, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00230503
    Brief Title
    Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
    Official Title
    Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (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 safety of four oral doses of pradefovir after 48 weeks of treatment Select the dose of pradefovir for Phase 3 studies
    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

    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
    Randomized
    Enrollment
    220 (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
    No
    Eligibility Criteria
    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
    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

    Citations:
    PubMed Identifier
    34487151
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

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