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Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B Virus

Intervention: Telbivudine (Drug); Tenofovir (Drug); Telbivudine plus tenofovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy daily (QD). This is an open labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.

Clinical Details

Official title: A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Monotherapy Given Over 12 Weeks on the Kinetics of Hepatitis B Virus DNA in Adults With HBeAg Positive Compensated CHB

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.

Secondary outcome:

Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.

Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12

Percentage of Patients Who Achieve Hepatitis B "e" Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12

Characterization of Very Early Viral Kinetics Through Estimated Viral Load

Characterization of Very Early Viral Kinetics Through Viral Clearance

Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss

Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.

Characterization of Very Early Viral Kinetics Through Half-live of Free Virus

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or

HBsAg positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc

- Age < 40 years old

- HBeAg positive

- HBV DNA > or = to 10^7 copies/mL by Abbott real-time PCR

- ALT < or = to 1 ULN

- Willing and able to provide written informed consent

- No prior oral HBV therapy (e. g., nucleotide and/or nucleoside therapy or other

investigational agents for HBV infection)

- Is willing and able to comply with the study drug regimen and all other study

procedures and requirements

- Is willing and able to provide written informed consent before any study assessment

is perform Exclusion Criteria:

- Decompensated liver disease defined as direct (conjugated) bilirubin > 1. 2 × ULN, PT

> 1. 2 × ULN, platelets < 150,000/mm3, serum albumin < 3. 5 g/dL, or prior history of clinical hepatic decompensation (e. g. ascites, jaundice, encephalopathy, variceal hemorrhage).

- Received interferon (pegylated or not) therapy within 6 months of the screening visit

- α-fetoprotein > 50 ng/mL

- Evidence of hepatocellular carcinoma (HCC)

- Co-infection with HCV (by serology), or HIV,

- Significant renal, cardiovascular, pulmonary, or neurological disease.

- Received solid organ or bone marrow transplantation.

- Is currently receiving therapy with immunomodulators (e. g., corticosteroids, etc.),

investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.

- Has proximal tubulopathy.

- Use of other investigational drugs at the time of enrollment, or within 30 days

- History of hypersensitivity to any of the study drugs or to drugs of similar chemical

classes

- Is pregnant or breastfeeding.

- Is a women of child-bearing potential (WOCBP)unless post-menopausal or using one or

more acceptable method of contraception.

- Patient has any other concurrent medical or social condition likely to preclude

compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.

- Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol

abuse or illicit substance abuse within the preceding two years.

- Patient has a medical condition that requires prolonged or frequent use of systemic

acyclovir or famciclovir. Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Department of Medicine, Queen Mary Hospital, Hong Kong, China
Additional Information

Starting date: November 2008
Last updated: January 26, 2012

Page last updated: August 23, 2015

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