Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
NCT ID: NCT00230503
Last Updated: 2012-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2004-06-30
2006-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Select the dose of pradefovir for Phase 3 studies
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
NCT00230490
Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B
NCT00071201
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study
NCT04543565
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
NCT02956850
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
NCT00116805
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pradefovir mesylate
adefovir dipivoxyl
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ralph T. Doyle
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RNA200103-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.