Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01940471
First received: August 20, 2013
Last updated: July 22, 2014
Last verified: July 2014

August 20, 2013
July 22, 2014
September 2013
November 2015   (final data collection date for primary outcome measure)
The proportion of participants with hepatitis B virus (HBV) DNA < 29 IU/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
The primary efficacy endpoint is determined by the achievement of HBV DNA < 29 IU/mL at Week 48.
Same as current
Complete list of historical versions of study NCT01940471 on ClinicalTrials.gov Archive Site
  • The proportion of participants with hepatitis B e antigen (HBeAg) loss with seroconversion to antibody against HBeAb (anti-HBe) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percent change from baseline at Week 48 in hip and spine bone mineral density (BMD) [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline at Week 48 in serum creatinine [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg Positive, Chronic Hepatitis B

The purpose of this study is to evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disoproxil fumarate (TDF) in treatment naive and experienced adult subjects with chronic hepatitis B virus (HBV) infection, as determined by the achievement of HBV DNA < 29 IU/mL at Week 48.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HBV
  • Chronic HBV Infections
  • Drug: Tenofovir alafenamide
    Tenofovir alafenamide 25 mg tablet administered orally once daily
  • Drug: Tenofovir disoproxil fumarate
    Tenofovir disoproxil fumarate 300 mg tablet administered orally once daily
    Other Name: Viread®
  • Drug: Placebo to match tenofovir alafenamide
    Placebo to match tenofovir alafenamide administered as a tablet orally once daily
  • Drug: Placebo to match tenofovir DF
    Placebo to match tenofovir DF administered as a tablet orally once daily
  • Experimental: Tenofovir alafenamide
    Tenofovir alafenamide plus placebo to match tenofovir DF for 96 weeks, followed by open-label tenofovir alafenamide through Week 144.
    Interventions:
    • Drug: Tenofovir alafenamide
    • Drug: Placebo to match tenofovir DF
  • Active Comparator: Tenofovir disoproxil fumarate
    Tenofovir DF plus placebo to match tenofovir alafenamide for 96 weeks, followed by open-label tenofovir alafenamide through Week 144.
    Interventions:
    • Drug: Tenofovir alafenamide
    • Drug: Tenofovir disoproxil fumarate
    • Drug: Placebo to match tenofovir alafenamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
864
May 2018
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  2. Adult males and non-pregnant, non-lactating females, 18 years of age and older
  3. Documented evidence of chronic HBV (CHB) infection
  4. HBeAg-positive, chronic hepatitis B with all of the following:

    • HBeAg-positive at screening
    • Screening HBV DNA ≥ 2 x 10^4 IU/mL
    • Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN)
  5. Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced participants (defined as participants meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue)
  6. Previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit
  7. Adequate renal function
  8. Normal ECG

Exclusion Criteria

  1. Females who are breastfeeding
  2. Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
  3. Co-infection with hepatitis C, HIV or hepatitis D virus (HDV)
  4. Evidence of hepatocellular carcinoma
  5. Any clinical and/or laboratory evidence of hepatic decompensation
  6. Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN
  7. Received solid organ or bone marrow transplant
  8. History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; participants under evaluation for possible malignancy are not eligible
  9. Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
  10. Subjects receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or subjects with a known hypersensitivity to study drugs, metabolites, or formulation excipients
  11. Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
  12. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
Both
18 Years and older
No
Contact: Charlene Kranz TAF4HBV@gilead.com
United States,   Australia,   Bulgaria,   Canada,   China,   France,   Hong Kong,   India,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom
 
NCT01940471
GS-US-320-0110
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: John Flaherty, PharmD Gilead Sciences
Gilead Sciences
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP