Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
864

Exclusion Criterias

Received solid organ or bone marrow transplant
Females who are breastfeeding
Evidence of hepatocellular carcinoma
...
Received solid organ or bone marrow transplant
Females who are breastfeeding
Evidence of hepatocellular carcinoma
Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN
Any history of, or current evidence of, clinical hepatic decompensation
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
Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible
Co-infection with hepatitis C virus, HIV, or hepatitis D virus

Summary

Conditions
  • Chronic HBV Infection
  • HBV
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study GS-US-320-0110 is an international study planned to enroll participants in global countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohor...

This study GS-US-320-0110 is an international study planned to enroll participants in global countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohorts were registered separately (NCT02836249) on ClinicalTrials.gov as these cohorts will not be part of the main study analysis.

Exclusion Criterias

Received solid organ or bone marrow transplant
Females who are breastfeeding
Evidence of hepatocellular carcinoma
...
Received solid organ or bone marrow transplant
Females who are breastfeeding
Evidence of hepatocellular carcinoma
Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN
Any history of, or current evidence of, clinical hepatic decompensation
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
Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible
Co-infection with hepatitis C virus, HIV, or hepatitis D virus

Locations

Flushing, New York, 11355
Novosibirsk, 630084
Clayton, Victoria, 3168
Palo Alto, California, 94304
Camperdown, New South Wales, 2050
...
Flushing, New York, 11355
Novosibirsk, 630084
Clayton, Victoria, 3168
Palo Alto, California, 94304
Camperdown, New South Wales, 2050
Bialystok, 15-540
Coimbatore, 641005
Diyarbakir, 21280
Seoul, 156-707
Tainan, 70403
Nottingham, NG7 2UH
Adelaide, South Australia, 5000
Taichung, 404
Concord, New South Wales, 2137
Pasadena, California, 91105
New Delhi, 110070
Constanţa, 900709
Detroit, Michigan, 48202
Lipetsk, 398043
Sha Tin
Kolkata, 700 094
Yekaterinburg, 620102
Novosibirsk, 630099
Busan, Seo-gu, 602702
Hyderabad, 500058
Chandigarh, 160012
San Jose, California, 95128
Seoul, 138-736
Ottawa, Ontario, K1H 8L6
Padova, 35100
Hamilton, 2001
Footscray, Victoria, 3011
Gyeonggi-do, 443-380
Philadelphia, Pennsylvania, 19107
Singapore, 169608
Sofia, 1407
Fukuoka, Fukuoka-shi, 812-8582
Winnipeg, Manitoba, R3E 3P4
Busan, 602-739
London, SE5 9RS
Villejuif, 94804
Vancouver, British Columbia, V6A 4B6
Moscow, 119435
Flushing, New York, 11354
Izmir, 35100
Melbourne, Victoria, 3004
London, NW3 2QG
London, E1 1BB
Wŏnju, 220-701
Los Angeles, California, 90020
Sevilla, 4103
Bologna, 40138
Taipei, 220
Fukuoka, 803-8505
Boston, Massachusetts, 02111
Mumbai, Maharashtra, 400008
Chorzow, 41-500
Nishinomiya, 663-8501
Bucharest, 030303
Istanbul, 34098
Calgary, Alberta, T2N 4Z6
Messina, 98124
Miami, Florida, 33136
Vancouver, British Columbia, V5Z 1H2
Bucuresti, 021105
Westmead, New South Wales, 2145
New Delhi, 110029
Hualien, 970
Seoul, 110-744
Taipei, 10002
Strasbourg, 67091
Moscow, 115446
Sapporo, 060-8648
Mumbai, 400012
Auckland, 1142
Seoul, 120-752
Perth, Western Australia, 6000
Tokyo, 113-8519
Kaohsiung, 80756
Nagpur, Maharashtra, 440003
Samara, 443063
Jaipur, Rajasthan, 302004
Gyeonggi-do, 411-706
Arlington, Texas, 76012
Musashino, 180-8610
Tai Po
Parel, 400 012
Kyoto, 602-8566
Kagawa, 760-8557
Ulsan, 682-714
Hyderabad, 500004
Milano, 20142
Yangsan, 626-770
Vancouver, British Columbia, V6Z 2C7
Edmonton, Alberta, T6G 2X8
Houston, Texas, 77005
Kofu, 400-8506
New Delhi, 110060
Bursa, 16059
Lai Chi Kok
Sofia, 1431
Omura, 856-8562
Lodz, 91-347
Warszawa, 01-201
Osaka, 543-8555
Surat, 395002
Wroclaw, 50-349
Hong Kong
Sofia, 1797
Daegu, 700-712
Hyderabad, 500004
Catonsville, Maryland, 21228
Padova, 35121
Cheonan, 330-721
Vancouver, British Columbia, V5Z 1M9
Seoul, 156-755
Chiayi, 60002
Okayama, 700-8558
Saint-Petersburg, 197376
Fitzroy, Victoria, 3065
Footscray, Victoria, 3011
Ankara, 06100
Vancouver, British Columbia, V6Z 2K5
Singapore, 529889
Jaipur, 302001
Clichy, 92110
Daejeon, 302-718
Philadelphia, Pennsylvania, 19107
Nagpur, Maharashtra, 440010
Seoul, 137-701
Toronto, Ontario, M6H 3M1
Moscow, 117198
Taipei, 10630
Fukuoka, 810-8563
Tuen Mun
Iasi, 700506
Heidelberg, Victoria, 3084
Kolkata, 700020
Osaka, 545-8586
Pisa, 56124
Toronto, Ontario, M5G 2C4
Foggia, 71100
Toronto, Ontario, M5T 2S8
Gyeonggi-Do, 463-707
Seoul, 135-720
Seoul, 135-710
Chennai, 600113
Timişoara, 300736
Moscow, 121170
Kurume, 830-0011
Singapore, 119228
San Diego, California, 92105
Kobe, 650-0047
Sofia, 1606
Daegu, 700-721
Seoul, 152-703
Parkville, Victoria, 3050
Seoul, 143-729
Barcelona, 08035
Saint-Petersburg, 191167
Paris, 75651

Tracking Information

NCT #
NCT01940471
Collaborators
Not Provided
Investigators
Study Director: Gilead Study Director Gilead Sciences