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Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tenofovir disoproxil fumarate
GS-4774
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
  • Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months
  • Screening HBV DNA ≥ 2000 IU/mL
  • A negative serum pregnancy test is required for females (unless surgically sterile or > 2 years post-menopausal)

Key Exclusion Criteria:

  • Cirrhosis
  • Inadequate liver function
  • Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
  • Received antiviral treatment for HBV within 3 months of screening
  • Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
  • Significant cardiovascular, pulmonary, or neurological disease
  • Women who are pregnant or may wish to become pregnant during the course of the study
  • Received solid organ or bone marrow transplant
  • Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
  • Use of investigational agents within 3 months of screening
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
  • Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
  • History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
  • Documented history of yeast allergy
  • Known hypersensitivity to study drugs, metabolites or formulation excipients
  • Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Stanford University Medical Center
  • Kaiser Permanente
  • Research and Education, Inc.
  • Kaiser Permanente San Francisco
  • Silicon Valley Research Institute
  • The Queen's Medical Center
  • Digestive Disease Associates, PA
  • Tufts Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Xiaoli Ma, PC
  • Virginia Commonwealth University
  • Kaiser Permanente
  • Gordon & Leslie Diamond Health Care Centre
  • Liver and Intestinal Research Center
  • University of Manitoba
  • Toronto General Hospital-The University Health Network
  • Toronto Liver Centre
  • Toronto Western Hospital-The University Health Network
  • Aou-S.Orsola-Malpighi - Universita Degli Studi Di
  • Azienda Ospedaliero-Universitaria di Parma
  • Azienda Ospedaliero-Universitaria Pisana
  • IRCCS Casa Sollievo della Sofferenza
  • Kyungpook National University Hospital
  • The Catholic University of Korea
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Seoul National University College of Medicine
  • Yonsei Universiity
  • Pusan National University Yangsan Hospital
  • The Catholic University of Korea
  • Auckland Clinical Studies
  • Dr. Victor Babes Hospital for Infectious Diseases
  • Institutul National de Boli Infectioase Prof.Dr. Matei Bals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

TDF 48 weeks

TDF plus GS-4774 2 YU

TDF plus GS-4774 10 YU

TDF plus GS-4774 40 YU

Arm Description

Participants will receive TDF for 48 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.

Participants will receive TDF plus GS-4774 2 yeast units (YU) for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.

Participants will receive TDF plus GS-4774 10 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.

Participants will receive TDF plus GS-4774 40 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.

Outcomes

Primary Outcome Measures

Mean Change in Serum HBsAg From Baseline to Week 24
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).

Secondary Outcome Measures

Mean Change in HBsAg From Baseline to Week 12
The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Mean Change in HBsAg From Baseline to Week 48
The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Percentage of Participants With HBsAg Loss at Week 24
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Percentage of Participants With HBsAg Loss at Week 48
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Percentage of Participants With HBeAg Loss at Week 24
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Percentage of Participants With HBeAg Loss at Week 48
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24
The LLOQ was defined as 20 IU/mL.
Percentage of Participants With HBV DNA < LLOQ at Week 48
The LLOQ was defined as 20 IU/mL.
Percentage of Participants Experiencing Virologic Breakthrough at Week 24
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Percentage of Participants Experiencing Virologic Breakthrough at Week 48
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available
Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing.

Full Information

First Posted
June 23, 2014
Last Updated
May 15, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02174276
Brief Title
Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
Official Title
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2014 (Actual)
Primary Completion Date
February 17, 2016 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TDF 48 weeks
Arm Type
Active Comparator
Arm Description
Participants will receive TDF for 48 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.
Arm Title
TDF plus GS-4774 2 YU
Arm Type
Experimental
Arm Description
Participants will receive TDF plus GS-4774 2 yeast units (YU) for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.
Arm Title
TDF plus GS-4774 10 YU
Arm Type
Experimental
Arm Description
Participants will receive TDF plus GS-4774 10 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.
Arm Title
TDF plus GS-4774 40 YU
Arm Type
Experimental
Arm Description
Participants will receive TDF plus GS-4774 40 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate
Other Intervention Name(s)
TDF, Viread®
Intervention Description
TDF 300 mg tablet administered orally once daily
Intervention Type
Biological
Intervention Name(s)
GS-4774
Intervention Description
GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses
Primary Outcome Measure Information:
Title
Mean Change in Serum HBsAg From Baseline to Week 24
Description
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Mean Change in HBsAg From Baseline to Week 12
Description
The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Time Frame
Baseline to Week 12
Title
Mean Change in HBsAg From Baseline to Week 48
Description
The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Time Frame
Baseline to Week 48
Title
Percentage of Participants With HBsAg Loss at Week 24
Description
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Time Frame
Baseline to Week 24
Title
Percentage of Participants With HBsAg Loss at Week 48
Description
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Time Frame
Baseline to Week 48
Title
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
Description
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Time Frame
Baseline to Week 24
Title
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
Description
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Time Frame
Baseline to Week 48
Title
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
Description
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
Description
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Time Frame
Baseline to Week 24
Title
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
Description
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Time Frame
Baseline to Week 48
Title
Percentage of Participants With HBeAg Loss at Week 24
Description
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Time Frame
Baseline to Week 24
Title
Percentage of Participants With HBeAg Loss at Week 48
Description
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Time Frame
Baseline to Week 48
Title
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24
Description
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Time Frame
Baseline to Week 24
Title
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48
Description
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Time Frame
Baseline to Week 48
Title
Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24
Description
The LLOQ was defined as 20 IU/mL.
Time Frame
Week 24
Title
Percentage of Participants With HBV DNA < LLOQ at Week 48
Description
The LLOQ was defined as 20 IU/mL.
Time Frame
Week 48
Title
Percentage of Participants Experiencing Virologic Breakthrough at Week 24
Description
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Time Frame
Baseline to Week 24
Title
Percentage of Participants Experiencing Virologic Breakthrough at Week 48
Description
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Time Frame
Baseline to Week 48
Title
Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available
Description
Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing.
Time Frame
Baseline to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months Screening HBV DNA ≥ 2000 IU/mL A negative serum pregnancy test is required for females (unless surgically sterile or > 2 years post-menopausal) Key Exclusion Criteria: Cirrhosis Inadequate liver function Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV) Received antiviral treatment for HBV within 3 months of screening Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging) Significant cardiovascular, pulmonary, or neurological disease Women who are pregnant or may wish to become pregnant during the course of the study Received solid organ or bone marrow transplant Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening Use of investigational agents within 3 months of screening Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance Receipt of immunoglobulin or other blood products within 3 months prior to enrollment History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease Documented history of yeast allergy Known hypersensitivity to study drugs, metabolites or formulation excipients Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Kaiser Permanente
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research and Education, Inc.
City
San Diego
State/Province
California
Country
United States
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
Silicon Valley Research Institute
City
San Jose
State/Province
California
Country
United States
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Digestive Disease Associates, PA
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
Country
United States
Facility Name
Xiaoli Ma, PC
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Kaiser Permanente
City
Springfield
State/Province
Virginia
Country
United States
Facility Name
Gordon & Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Liver and Intestinal Research Center
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Toronto General Hospital-The University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Western Hospital-The University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Aou-S.Orsola-Malpighi - Universita Degli Studi Di
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma
City
Parma
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
Country
Italy
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Seocho
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei Universiity
City
Seoul
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Yangsan
Country
Korea, Republic of
Facility Name
Auckland Clinical Studies
City
Auckland
Country
New Zealand
Facility Name
Dr. Victor Babes Hospital for Infectious Diseases
City
Bucharest
Country
Romania
Facility Name
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
City
Bucharest
Country
Romania

12. IPD Sharing Statement

Citations:
Citation
Janssen HL, Yoon SK, Yoshida EM, Trinh HN, Rodell TC, Nguyen AH, et al. Safety and Efficacy of GS-4774 in combination with TDF in Patients with Chronic Hepatitis B not on Antiviral Medication [Abstract 231]. Hepatology AASLD Abstracts 2016;64 (Suppl S1):122A.
Results Reference
result
PubMed Identifier
30930022
Citation
Boni C, Janssen HLA, Rossi M, Yoon SK, Vecchi A, Barili V, Yoshida EM, Trinh H, Rodell TC, Laccabue D, Alfieri A, Brillo F, Fisicaro P, Acerbi G, Pedrazzi G, Andreone P, Cursaro C, Margotti M, Santoro R, Piazzolla V, Brunetto MR, Coco B, Cavallone D, Zhao Y, Joshi A, Woo J, Lau AH, Gaggar A, Subramanian GM, Massetto B, Fung S, Ahn SH, Ma X, Mangia A, Ferrari C. Combined GS-4774 and Tenofovir Therapy Can Improve HBV-Specific T-Cell Responses in Patients With Chronic Hepatitis. Gastroenterology. 2019 Jul;157(1):227-241.e7. doi: 10.1053/j.gastro.2019.03.044. Epub 2019 Mar 28.
Results Reference
result

Learn more about this trial

Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment

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