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Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

2014-07-23 21:35:20 | BioPortfolio

Summary

This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hepatitis B

Intervention

telbivudine, adefovir dipivoxil

Location

Novartis
San Diego
California
United States

Status

Terminated

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:20-0400

Clinical Trials [1258 Associated Clinical Trials listed on BioPortfolio]

Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food a...

EFFORT Further Extension Study

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fib...

Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have be...

A Phase II Study to Determine the Safety and Efficacy of Interferon-Gamma in Patients With Chronic Hepatitis B

Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipi...

Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis

This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed with bi...

PubMed Articles [1301 Associated PubMed Articles listed on BioPortfolio]

Comparing Efficacy of Lamivudine, Adefovir Dipivoxil, Telbivudine, and Entecavir in Treating Nucleoside Analogues Naïve for HBeAg-Negative Hepatitis B with Medium Hepatitis B Virus (HBV) DNA Levels.

BACKGROUND The antiviral effect of HBV in different nucleos (t) ide analogues is still not well known. This study was conducted to compare the effectiveness of lamivudine (LMV), adefovir dipivoxil (AD...

Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients.

The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable switching) in patients with LAM-resistant c...

Telbivudine associated mitochondrial myopathy.

A 62-year-old male had a history of hepatitis B virus infection with fulminant hepatitis status post liver transplant in 2 years ago presented to Rheumatology clinic with one-year history of progressi...

Trends in Hepatitis B Virus Resistance to Nucleoside/Nucleotide Analogs in North China from 2009 to 2016: A Retrospective Study.

Nucleos(t)ide analogs (NAs) are widely used in anti-hepatitis B virus (HBV) therapy for effective inhibition of HBV replication. However, HBV resistance to NAs has emerged, resulting in virus reactiva...

Motor development delay in offspring is associated with prenatal telbivudine exposure.

Telbivudine is an orally nucleoside analog with potent and specific antihepatitis B virus (HBV) activity, and it has been reported to block mother-to-infant transmission. However, few studies have foc...

Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

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