search
Back to results

Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

Primary Purpose

Hepatitis B

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GSK3228836
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis B focused on measuring GSK3228836, B-Sure, Nucleos(t)ide, Sustained virologic response, durability

Eligibility Criteria

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

Inclusion criteria:

  • Participants who have previously received at least one dose of GSK3228836 and

    1. Achieved SVR (defined as HBsAg and HBV DNA < lower limit of quantification (LLOQ) from end of previous investigational treatment until the End of study (EoS) visit in the previous treatment study (complete responder) OR
    2. Participants who have previously received at least one dose of GSK3228836 and demonstrated a partial response to GSK3228836 in the previous treatment study
  • Participants who enter the study on stable NA must be willing to discontinue NA treatment in accordance with the NA discontinuation schedule.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836.
  • Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nucleos(t)ide analogue (NA) naïve participants

NA controlled participants

Arm Description

Participants who have not received NA therapy during the parent study. No study treatment will be administered in this study.

Participants who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods. NA cessation at 3 months. No study treatment will be administered in this study.

Outcomes

Primary Outcome Measures

Time from achieving SVR in previous GSK3228836 treatment study to loss of SVR (1st occurrence of either hepatitis B surface antigen or hepatitis B virus deoxyribonucleic acid [DNA] reversion, or 1st use of any rescue medication)-NA naïve participants
NA indicates Nucleos(t)ide analogue (NA)
Time from NA cessation to the loss of SVR-NA controlled participants

Secondary Outcome Measures

Time from NA cessation to the first occurrence of hepatitis B surface antigen (HBsAg) reversion or first use of any rescue medication- NA controlled participants
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
Time from NA cessation to NA retreatment- NA controlled participants
Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR- NA controlled participants
Percentage of participants with delayed SVR in absence of rescue medication after the end of parent study- NA naïve participants
Time to the loss of SVR from time of achieving delayed SVR (NA naïve participants achieving delayed SVR)
Percentage of participants with delayed SVR in the absence of any rescue medication after end of the parent study (NA controlled participants continuing NA treatment)
Time to the loss of SVR from time of achieving delayed SVR (NA controlled participants continuing NA treatment)
Percentage of participants with delayed SVR, in the absence of NA retreatment after NA cessation (NA controlled participants who have discontinued NA treatment)
Time to the loss of SVR from time of achieving SVR (NA controlled participants who have discontinued NA treatment)
Percentage of participants with HBsAg loss in the absence of any rescue medication after NA cessation- NA controlled participants with partial response
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants with partial response
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication- NA controlled participants with partial response
Time from NA cessation to the first occurrence of NA retreatment- NA controlled participants with partial response
Percentage of participants with anti-HBs (antibody to HBsAg)
Percentage of participants with anti-HBe (antibody to HBeAg)
Absolute values for HbsAg, hepatitis B virus (HBV) DNA, hepatitis B e-antigen (HbeAg) (logarithm to the base 10 [log10] International units per milliliter [IU/mL])
Change from Baseline for HbsAg, HBV DNA, HbeAg (log10 IU/mL)
Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL])
Change from Baseline for HbcrAg (kU/mL)
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)
Change from Baseline for HBV RNA (log10 IU/ml)
Percentage of participants with mutations

Full Information

First Posted
June 29, 2021
Last Updated
November 24, 2022
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT04954859
Brief Title
Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)
Official Title
A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

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

5. Study Description

Brief Summary
This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
GSK3228836, B-Sure, Nucleos(t)ide, Sustained virologic response, durability

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nucleos(t)ide analogue (NA) naïve participants
Arm Type
Experimental
Arm Description
Participants who have not received NA therapy during the parent study. No study treatment will be administered in this study.
Arm Title
NA controlled participants
Arm Type
Experimental
Arm Description
Participants who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods. NA cessation at 3 months. No study treatment will be administered in this study.
Intervention Type
Drug
Intervention Name(s)
GSK3228836
Intervention Description
No study drug will be administered in this study. Eligible participants who received prior treatment with GSK3228836 in the parent studies will be included.
Primary Outcome Measure Information:
Title
Time from achieving SVR in previous GSK3228836 treatment study to loss of SVR (1st occurrence of either hepatitis B surface antigen or hepatitis B virus deoxyribonucleic acid [DNA] reversion, or 1st use of any rescue medication)-NA naïve participants
Description
NA indicates Nucleos(t)ide analogue (NA)
Time Frame
From primary endpoint assessment in the previous GSK3228836 study up to End of Study (Month 33)
Title
Time from NA cessation to the loss of SVR-NA controlled participants
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary Outcome Measure Information:
Title
Time from NA cessation to the first occurrence of hepatitis B surface antigen (HBsAg) reversion or first use of any rescue medication- NA controlled participants
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Title
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Title
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Title
Time from NA cessation to NA retreatment- NA controlled participants
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Title
Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR- NA controlled participants
Time Frame
From primary endpoint assessment in the previous GSK 3228836 study up to End of Study (Month 33)
Title
Percentage of participants with delayed SVR in absence of rescue medication after the end of parent study- NA naïve participants
Time Frame
Months 0, 3, 9, 15, 21, 27, 33
Title
Time to the loss of SVR from time of achieving delayed SVR (NA naïve participants achieving delayed SVR)
Time Frame
From date of achieving SVR up to End of Study (Month 33)
Title
Percentage of participants with delayed SVR in the absence of any rescue medication after end of the parent study (NA controlled participants continuing NA treatment)
Time Frame
Months 0, 2.5, 9, 15, 21, 27, 33
Title
Time to the loss of SVR from time of achieving delayed SVR (NA controlled participants continuing NA treatment)
Time Frame
From date of achieving SVR up to End of Study (Month 33)
Title
Percentage of participants with delayed SVR, in the absence of NA retreatment after NA cessation (NA controlled participants who have discontinued NA treatment)
Time Frame
Months 6, 9, 15, 21, 27, 33
Title
Time to the loss of SVR from time of achieving SVR (NA controlled participants who have discontinued NA treatment)
Time Frame
From date of achieving SVR up to End of Study (Month 33)
Title
Percentage of participants with HBsAg loss in the absence of any rescue medication after NA cessation- NA controlled participants with partial response
Time Frame
Months 6, 9, 15, 21, 27, 33
Title
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants with partial response
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Title
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication- NA controlled participants with partial response
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Title
Time from NA cessation to the first occurrence of NA retreatment- NA controlled participants with partial response
Time Frame
From Visit 3 (Month 3) up to End of Study (Month 33)
Title
Percentage of participants with anti-HBs (antibody to HBsAg)
Time Frame
Up to 33 months
Title
Percentage of participants with anti-HBe (antibody to HBeAg)
Time Frame
Up to 33 months
Title
Absolute values for HbsAg, hepatitis B virus (HBV) DNA, hepatitis B e-antigen (HbeAg) (logarithm to the base 10 [log10] International units per milliliter [IU/mL])
Time Frame
Up to 33 months
Title
Change from Baseline for HbsAg, HBV DNA, HbeAg (log10 IU/mL)
Time Frame
Baseline and up to 33 months
Title
Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL])
Time Frame
Up to 33 months
Title
Change from Baseline for HbcrAg (kU/mL)
Time Frame
Baseline and up to 33 months
Title
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)
Time Frame
Up to 33 months
Title
Change from Baseline for HBV RNA (log10 IU/ml)
Time Frame
Baseline and up to 33 months
Title
Percentage of participants with mutations
Time Frame
Up to 33 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants who have previously received at least one dose of GSK3228836 and Achieved SVR (defined as HBsAg and HBV DNA < lower limit of quantification (LLOQ) from end of previous investigational treatment until the End of study (EoS) visit in the previous treatment study (complete responder) OR Participants who have previously received at least one dose of GSK3228836 and demonstrated a partial response to GSK3228836 in the previous treatment study Participants who enter the study on stable NA must be willing to discontinue NA treatment in accordance with the NA discontinuation schedule. Capable of giving signed informed consent. Exclusion Criteria: Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Sebastian Marciano
Facility Name
GSK Investigational Site
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Dimitar Pavlov
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Diana Petrova
Facility Name
GSK Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Wayne Ghesquiere
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Harry Janssen
Facility Name
GSK Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Qin Ning
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jidong Jia
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Qing Xie
Facility Name
GSK Investigational Site
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Tarik Asselah
Facility Name
GSK Investigational Site
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Lawrence Serfaty
Facility Name
GSK Investigational Site
City
Pokfulam
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Man Fung Yuen
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Giuliano Rizzardini
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
790-8524
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kouji Joko
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Keiji Tsuji
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Michio Imamura
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Hiroshi Kohno
Facility Name
GSK Investigational Site
City
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Takuya Komura
Facility Name
GSK Investigational Site
City
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Koichi Takaguchi
Facility Name
GSK Investigational Site
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Shigetoshi Fujiyama
Facility Name
GSK Investigational Site
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jun Inoue
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Tetsuo Takehara
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Masanori Atsukawa
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Masayuki Kurosaki
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Sung-Jae Park
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jeong Heo
Facility Name
GSK Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Hyung Joon Yim
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Young-Suk Lim
Facility Name
GSK Investigational Site
City
Lancut
ZIP/Postal Code
37-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Robert Plesniak
Facility Name
GSK Investigational Site
City
Craiova
ZIP/Postal Code
417307
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Gheorghe Iulian Diaconescu
Facility Name
GSK Investigational Site
City
Galati
ZIP/Postal Code
800179
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Manuela Arbune
Facility Name
GSK Investigational Site
City
Chelyabinsk
ZIP/Postal Code
454052
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Olga Sagalova
Facility Name
GSK Investigational Site
City
Krasnojarsk
ZIP/Postal Code
660049
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Natalya Urievna Gankina
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
121170
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Tatyana Stepanova
Facility Name
GSK Investigational Site
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Natalya B. Voloshina
Facility Name
GSK Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Denis A. Gusev
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Seng-Gee Lim
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jessica Tan
Facility Name
GSK Investigational Site
City
Ennerdale
State/Province
Gauteng
ZIP/Postal Code
1830
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Agatha C Wilhase
Facility Name
GSK Investigational Site
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Rosie Mngqibisa
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kittiyod Poovorawan
Facility Name
GSK Investigational Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Teerha Piratvisuth
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
WC1E 6JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Stuart Flanagan
Facility Name
GSK Investigational Site
City
Plymouth
ZIP/Postal Code
PL68DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Matthew Cramp

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

We'll reach out to this number within 24 hrs