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ACH-126, 443

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Feb 18, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

ACH-126, 443 · 1 trial · 1 indication

Phase 2 1
NCT00034359Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus InfectionHepatitis B, Chronic
COMPLETED79 Analytics
PHASE2COMPLETED
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
Hepatitis B, ChronicUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ACH-126,443DRUG -
LamivudineDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months. * Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter. * Hepatitis B e-antigen positive. * Human immunodeficiency virus negative. * Basic hematologic and chem...

Countries:BulgariaFederal Republic of Yugoslavia
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Frequently asked questions about ACH-126, 443

What is ACH-126,443 used for?

ACH-126,443 is an investigational small molecule being studied for the treatment of chronic hepatitis B. It was evaluated in a Phase 2 clinical trial in treatment-naive adults with chronic hepatitis B virus infection. The drug is not approved and remains in clinical development.

Who makes ACH-126,443?

ACH-126,443 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The company conducted a Phase 2 clinical trial of the drug in patients with chronic hepatitis B.

What phase is ACH-126,443 in?

ACH-126,443 is in Phase 2 clinical development. A Phase 2 study of the drug has been completed, but it is not approved and is still investigational. The completed trial enrolled 79 participants with chronic hepatitis B.

What clinical trials is ACH-126,443 in?

ACH-126,443 has one completed clinical trial, registered as NCT00034359. This Phase 2 study assessed the safety and antiviral activity of ACH-126,443 in treatment-naive adults with chronic hepatitis B virus infection. The trial enrolled 79 participants and was conducted in Bulgaria and the Federal Republic of Yugoslavia.

Is ACH-126,443 the same as beta-L-Fd4C?

ACH-126,443 is also known as beta-L-Fd4C. The clinical trial NCT00034359 evaluated ACH-126,443 (beta-L-Fd4C) in patients with chronic hepatitis B. Both names refer to the same investigational drug.