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A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)

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

Condition(s) targeted: Chronic Hepatitis B

Intervention: Tenofovir DF (Drug); FTC (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Summary

The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection. The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters. Participants were randomized in a 1: 1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.

Clinical Details

Official title: A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192

Secondary outcome:

Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144

Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192

Change From Baseline in HBV DNA at Week 48

Change From Baseline in HBV DNA at Week 96

Change From Baseline in HBV DNA at Week 144

Change From Baseline in HBV DNA at Week 192

Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192

Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192

Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192

Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192

Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192

Occurrence of HBV Resistance Mutations

Eligibility

Minimum age: 18 Years. Maximum age: 69 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 positive for immunoglobulin G antibody against hepatitis B core antigen

- 18 through 69 years of age, inclusive

- Hepatitis B e antigen (HBeAg) positive

- HBV DNA ≥ 10^8 copies/mL

- ALT ≤ the upper limit of the normal range (ULN)

- Willing and able to provide written informed consent

- Negative serum beta-human chorionic gonadotropin (for females of childbearing

potential only)

- Calculated creatinine clearance ≥ 70 mL/min

- Hemoglobin ≥ 10 g/dL

- Neutrophils ≥ 1,500/mm^3

- No prior oral HBV therapy (eg, nucleotide and/or nucleoside therapy or other

investigational agents for HBV infection) Exclusion Criteria:

- Pregnant women, women who were breast feeding, or who believed they may have wished

to become pregnant during the course of the study

- Males and females of reproductive potential unwilling to use an effective method of

contraception during the study

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

prothrombin time > 1. 2 x ULN, platelets < 150,000/mm^3, serum albumin < 3. 5 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, or variceal hemorrhage)

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

- Alpha-fetoprotein > 50 ng/mL

- Evidence of hepatocellular carcinoma

- Coinfection with hepatitis C virus (by serology), HIV, or hepatitis D virus

- Significant renal, cardiovascular, pulmonary, or neurological disease

- Received solid organ or bone marrow transplantation

- Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.),

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

- Had proximal tubulopathy

- Known hypersensitivity to the study drugs, the metabolites, or formulation excipients

Locations and Contacts

Lille 59037, France

Lyon 69288, France

Strasbourg 67091, France

Berlin 10969, Germany

Berlin 13353, Germany

Duesseldorf 40237, Germany

Frankfurt 60590, Germany

Hamburg 20251, Germany

Hannover 30623, Germany

Heidelberg 69120, Germany

Herne 44623, Germany

Mainz 55131, Germany

Pokfulam, Hong Kong

Shatin, Hong Kong

Tai Po, Hong Kong

Hamilton, New Zealand

Bydgoszcz 85-030, Poland

Chorzow 41-500, Poland

Warszawa 01-201, Poland

Singapore 119074, Singapore

Singapore 529889, Singapore

Kaohsiung 807, Taiwan

Kaoshiung 833, Taiwan

Tainan 107, Taiwan

Taipei, Taiwan

London NW3 2QG, United Kingdom

Sheffield S10 2JF, United Kingdom

Calgary, Alberta T2N4N1, Canada

Grafton, Auckland 1150, New Zealand

Vancouver, British Columbia V5Z1H2, Canada

Los Angeles, California 90048, United States

San Diego, California 92115, United States

San Francisco, California 11355, United States

Miami, Florida 33136, United States

Detroit, Michigan 48202, United States

Camperdown, New South Wales 2050, Australia

Westmead, New South Wales 2145, Australia

Manhasset, New York 11030, United States

New York, New York 10021, United States

New York, New York 10029-6574, United States

Toronto, Ontario M5G 2C4, Canada

Germantown, Tennessee 38138, United States

Heidelburg, Victoria 3081, Australia

Melbourne, Victoria 3004, Australia

Seattle, Washington 98111, United States

Additional Information

Starting date: September 2007
Last updated: July 7, 2015

Page last updated: August 23, 2015

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