Recent Updates
Recently added Catalysts

pradefovir

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
pradefovir mesylateDRUG -
adefovir dipivoxylDRUG -
Unlock Study Design Details

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 ...

Unlock Eligibility Criteria

Frequently asked questions about pradefovir

What is pradefovir used for?

Pradefovir is an investigational small molecule being developed for the treatment of chronic hepatitis B, a viral infection of the liver. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing pradefovir?

Pradefovir is being developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker symbol BHC. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with chronic hepatitis B.

What phase is pradefovir in?

Pradefovir is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its potential as a treatment for chronic hepatitis B.

What clinical trials has pradefovir been in?

Pradefovir has been studied in a completed Phase 2 clinical trial registered as NCT00230503, titled "Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B." This trial enrolled 220 adult patients with chronic hepatitis B and was not blinded or controlled.

Is pradefovir an approved treatment for hepatitis B?

No, pradefovir is not an approved treatment for hepatitis B. It is an investigational drug currently in Phase 2 clinical development. Its safety and efficacy have not been fully established, and it has not been reviewed or approved by regulatory agencies for commercial use.