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Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment Naive Adults With Chronic Hepatitis B Virus Infection

2014-07-23 21:55:05 | BioPortfolio

Summary

The purpose of this study is to determine the safety and anti-HBV activity of ACH-126, 443 (beta-L-Fd4C) in comparison to lamivudine or placebo in treatment naive adults with chronic Hepatitis B infection.

Description

Evaluation of safety and antiviral activity of 3 dose levels of ACH-126, 443 vs. lamivudine and placebo over 12 weeks of treatment in the population described.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Hepatitis B, Chronic

Intervention

ACH-126, 443 (beta-L-Fd4C)

Location

Clinic of Gastroenterology
Sofia
Bulgaria

Status

Completed

Source

Achillion Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:55:05-0400

Clinical Trials [1938 Associated Clinical Trials listed on BioPortfolio]

Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.

The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Stud...

Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B

The purpose of this study is to determine the safety and antiviral HBV activity of ACH126, 433 (b-L-Fd4C) in the treatment of adults with lamivudine-resistant chronic Hepatitis B.

Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.

To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral ther...

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The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic hepatitis C with better efficacy & safety profiles in monotherapy or combination ...

Study on Second Stage Follow-up of Therapeutic Hepatitis B Vaccine in Treating Chronic Hepatitis B Patients

Evaluation εPA-44 treatment of chronic hepatitis B patients with 144 weeks of efficacy and safety Provide the basis for determining dosage regimen of phase Ⅲ clinical trials

PubMed Articles [8443 Associated PubMed Articles listed on BioPortfolio]

Seroprevalence of hepatitis E virus in chronic hepatitis C in Brazil.

Hepatitis E virus infection in patients with underlying chronic liver disease is associated with liver decompensation and increased lethality. The seroprevalence of hepatitis E virus in patients with ...

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Hepatocellular carcinoma (HCC) is a common complication of chronic viral hepatitis. In support of this notion, we have reported that hepatitis B surface antigen (HBsAg)-specific CD8+ T lymphocytes cri...

Neurological manifestations in chronic hepatitis C patients receiving care in a reference hospital in sub-Saharan Africa: A cross-sectional study.

Chronic hepatitis C infection is a major public health concern, with a high burden in Sub-Saharan Africa. There is growing evidence that chronic hepatitis C virus (HCV) infection causes neurological c...

The Impact of Hepatitis B Vaccine Failure on Long-term Natural Course of Chronic Hepatitis B Virus Infection in Hepatitis B e Antigen-Seropositive Children.

Vaccine failure with chronic hepatitis B virus (HBV) infection still develops in children after universal hepatitis B immunization. This study aimed to investigate the natural course of chronic HBV in...

Accumulation of mutations in reverse transcriptase of hepatitis B virus is associated with liver disease severity in treatment-naïve Chinese patients with chronic hepatitis B.

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.

INFLAMMATION of the LIVER with ongoing hepatocellular injury for 6 months or more, characterized by NECROSIS of HEPATOCYTES and inflammatory cell (LEUKOCYTES) infiltration. Chronic hepatitis can be caused by viruses, medications, autoimmune diseases, and other unknown factors.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS in conjunction with HEPATITIS B VIRUS and lasting six months or more.

A closely related group of antigens found in the plasma only during the infective phase of hepatitis B or in virulent chronic hepatitis B, probably indicating active virus replication; there are three subtypes which may exist in a complex with immunoglobulins G.

A defective virus, containing particles of RNA nucleoprotein in virion-like form, present in patients with acute hepatitis B and chronic hepatitis. It requires the presence of a hepadnavirus for full replication. This is the lone species in the genus Deltavirus.

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