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pradefovir

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Trials Updated: Jun 22, 2012

pradefovir target and mechanism

ModalitySmall molecule

Also known as pradefovir mesylate

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

pradefovir clinical trials

pradefovir · 1 trial · 1 indication

Phase 2 1
NCT00230503Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis BHepatitis B, Chronic
COMPLETED220 Analytics
PHASE2COMPLETED
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Hepatitis B, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

- Efficacy: Proportion of patients with undetectable viral load
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
pradefovir mesylateDRUG -
adefovir dipivoxylDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo

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 ...

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Frequently asked questions about pradefovir

What is pradefovir used for?

Pradefovir is an investigational small molecule being studied for the treatment of chronic hepatitis B, a long-term viral infection of the liver. It is in Phase 2 clinical development and is not an approved therapy. It has been evaluated in a dose-ranging study in patients with compensated hepatitis B.

Who is developing pradefovir?

Pradefovir is being developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker BHC. The company is the sponsor associated with the clinical program for this hepatitis B candidate.

What phase is pradefovir in?

Pradefovir is in Phase 2 clinical development for chronic hepatitis B. It is an investigational agent and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently listed as active.

What clinical trials has pradefovir been studied in?

Pradefovir has been studied in NCT00230503, a Phase 2 dose-ranging trial titled "Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B." The trial enrolled 220 patients aged 18 years and older, was randomized, and has been completed.

Is pradefovir the same as pradefovir mesylate?

Yes, pradefovir mesylate is another name for pradefovir. The mesylate refers to the salt form of the same active small molecule, so searches for either name refer to the same investigational hepatitis B candidate developed by Bausch Health Companies Inc.

How was the pradefovir Phase 2 trial designed?

The completed Phase 2 trial, NCT00230503, was a randomized, dose-ranging study in patients with compensated chronic hepatitis B. It enrolled 220 participants aged 18 years and older of any sex, excluded healthy volunteers, and did not use a blinded or controlled design.