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AAAA

Phase 3

Chronic Hepatitis B | Small molecule | Infectious Disease |GSK plc|Last Updated: Apr 3, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment480

FDA Designations

No designations recorded

Clinical trial landscape

AAAA · 1 trial · 1 indication

Phase 3 1
NCT00857675A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis BChronic Hepatitis B
COMPLETED480 Analytics
PHASE3COMPLETED
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B
Chronic Hepatitis B
NCT00857675480
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Study Endpoints

Primary Endpoints

The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
Week 12

Secondary Endpoints

The proportion of subjects with ALT normalisation
Week 52, 104, 156, 208, 260
log10 reduction in serum HBV DNA
Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
Week 52, 104, 156, 208, 260
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Adefovir DipivoxilEXPERIMENTALADV 10mg tablets once daily
Adefovir Dipivoxil matched placeboPLACEBO_COMPARATORAdefovir Dipivoxil matched placebo one tablet once daily

Interventions

NameTypeDescription
AAAADRUGAdefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)
AAPADRUGAdefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
PAAADRUGPlacebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Aged 18-65 years * Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening. * Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL...

Countries:China
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Frequently asked questions about AAAA

What is AAAA used for in Chronic Hepatitis B?

AAAA is an investigational small molecule being studied for the treatment of Chronic Hepatitis B. It is currently in Phase 3 clinical development. The drug has been evaluated in a completed Phase 3 trial in China involving 480 patients with HBeAg-positive Chronic Hepatitis B.

Who makes AAAA?

AAAA is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of AAAA in patients with Chronic Hepatitis B.

What phase is AAAA in?

AAAA is currently in Phase 3 clinical development for Chronic Hepatitis B. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by regulatory authorities.

What clinical trials is AAAA in?

AAAA has been studied in a Phase 3 clinical trial with the identifier NCT00857675. This trial, titled 'A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B,' was a randomized, double-blind, placebo-controlled study that enrolled 480 participants in China.

Is AAAA the same as Adefovir Dipivoxil?

Yes, AAAA is also known as Adefovir Dipivoxil. The Phase 3 clinical trial NCT00857675 evaluated the efficacy and safety of Adefovir Dipivoxil in Chinese patients with HBeAg-positive Chronic Hepatitis B. This alternative name is used in the clinical trial documentation.