B-Clear: A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT04449029
Collaborator
(none)
457
121
8
19.7
3.8
0.2

Study Details

Study Description

Brief Summary

Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
457 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants with CHB will be divided into two different cohorts; participants on stable nucleos(t)ide treatment and participants not currently on nucleos(t)ide therapy. For each cohort, participants will be randomized into one of the 4 different parallel arms to receive treatment.Participants with CHB will be divided into two different cohorts; participants on stable nucleos(t)ide treatment and participants not currently on nucleos(t)ide therapy. For each cohort, participants will be randomized into one of the 4 different parallel arms to receive treatment.
Masking:
Single (Participant)
Masking Description:
Participants will be blinded to the study treatment.
Primary Purpose:
Treatment
Official Title:
Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)
Actual Study Start Date :
Jul 27, 2020
Actual Primary Completion Date :
Mar 18, 2022
Actual Study Completion Date :
Mar 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: GSK3228836 300 mg + LD

Eligible participants on stable nucleos(t)ide treatment will receive 300 milligrams (mg) GSK3228836 once weekly for 24 weeks along with loading dose (LD) of 300 mg GSK3228836 on Day 4 and Day 11.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Drug: Nucleos(t)ide therapy
Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.

Experimental: Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo

Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Drug: Placebo
Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.

Drug: Nucleos(t)ide therapy
Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.

Experimental: Cohort 1: GSK3228836 300 mg + LD/ Placebo

Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Drug: Placebo
Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.

Drug: Nucleos(t)ide therapy
Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.

Experimental: Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD

Eligible participants on stable nucleos(t)ide treatment will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Drug: Placebo
Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.

Drug: Nucleos(t)ide therapy
Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.

Experimental: Cohort 2: GSK3228836 300 mg + LD

Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 24 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Experimental: Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo

Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Drug: Placebo
Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.

Experimental: Cohort 2: GSK3228836 300 mg + LD/ Placebo

Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Drug: Placebo
Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.

Experimental: Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD

Eligible participants not currently on nucleos(t)ide therapy will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.

Drug: GSK3228836
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Drug: Placebo
Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants achieving SVR [Up to Week 48]

    Sustained response is defined as a continuous 24 weeks from end of GSK3228836 treatment during which levels of HBsAg in serum remain <LLOQ and HBV DNA< LLOQ.

Secondary Outcome Measures

  1. Percentage of participants achieving HBsAg <LLOQ [Up to Week 24]

    Participants achieving HBsAg <LLOQ at the end of treatment will be assessed.

  2. Percentage of participants achieving HBV DNA <LLOQ [Up to Week 24]

    Participants achieving HBV DNA <LLOQ at the end of treatment will be assessed.

  3. Percentage of participants with alanine aminotransferase (ALT) normalization over time in absence of rescue medication [Up to Week 48]

    Participants with Baseline ALT greater than (>) upper limit of normal (ULN) will be assessed for ALT normalization in absence of rescue medication over time.

  4. HBsAg level at indicated time points [Day 1 to Week 48]

    Blood samples will be collected from participants to assess HBsAg level at indicated time points.

  5. Change from Baseline in HBsAg over time [Baseline (Day 1) and up to Week 48]

    Blood samples will be collected from participants to assess HBsAg level at indicated time points.

  6. HBV DNA level at indicated time points [Day 1 to Week 48]

    Blood samples will be collected from participants to assess HBV DNA level at indicated time points.

  7. Change from Baseline in HBV DNA over time [Baseline (Day 1) and up to Week 48]

    Blood samples will be collected from participants to assess HBV DNA level at indicated time points.

  8. Hepatitis B virus e-antigen (HBeAg) level at indicated time points [Day 1 to Week 48]

    Blood samples will be collected to assess HBeAg level of each participant.

  9. Change from Baseline in HBeAg level over time [Baseline (Day 1) and up to Week 48]

    Blood samples will be collected to assess HBeAg level of each participant.

  10. Hepatatis B surface antibody (HBsAb) level at indicated time points [Day 1 to Week 48]

    Blood samples will be collected to assess HBsAb level of each participant.

  11. Change from Baseline in HBsAb level over time [Baseline (Day 1) and up to Week 48]

    Blood samples will be collected to assess HBsAb level of each participant.

  12. HBeAb level at indicated time points [Day 1 to Week 48]

    Blood samples will be collected to assess HBeAb level of each participant.

  13. Change from Baseline in HBeAb level over time [Baseline (Day 1) and up to Week 48]

    Blood samples will be collected to assess HBeAb level of each participant.

  14. Time to ALT normalization in absence of rescue medication [Day 1 to Week 48]

    Time to ALT normalization in absence of rescue medication will be measured in participants with Baseline ALT>ULN.

  15. Percentage of participants achieving SVR over time [Up to Week 24]

    Sustained response is defined as a continuous 24 weeks from end of GSK3228836 treatment during which levels of HBsAg in serum remain less than LLOQ and HBV DNA less than LLOQ.

  16. Area under the concentration-time curve (AUC) following administration of GSK3228836- Intensive pharmacokinetics (PK) [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of GSK3228836 at indicated time points.

  17. AUC following administration of nucleos(t)ide therapy- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of nucleos(t)ide therapy at indicated time points.

  18. Concentration at the end of the dosing interval (Ctau) following administration of GSK3228836- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of GSK3228836 at indicated time points.

  19. Ctau following administration of nucleos(t)ide therapy- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of nucleos(t)ide therapy at indicated time points.

  20. Maximum observed concentration (Cmax) following administration of GSK3228836- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of GSK3228836 at indicated time points.

  21. Cmax following administration of nucleos(t)ide therapy- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of nucleos(t)ide therapy at indicated time points.

  22. Time of maximum observed concentration (tmax) following administration of GSK3228836- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of GSK3228836 at indicated time points.

  23. Tmax following administration of nucleos(t)ide therapy- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of nucleos(t)ide therapy at indicated time points.

  24. Apparent subcutaneous plasma clearance for GSK3228836- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of GSK3228836 at indicated time points.

  25. Apparent oral plasma clearance for nucleos(t)ide- Intensive PK [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of nucleos(t)ide therapy at indicated time points.

  26. Terminal half-life (T1/2) following administration of GSK3228836- All participants [From Week 15 to Week 44]

    Blood samples will be collected for PK analysis of GSK3228836 at indicated time points.

  27. T1/2 following administration of nucleos(t)ide therapy- All participants [Any one week between Week 14 to Week 24]

    Blood samples will be collected for PK analysis of nucleos(t)ide therapy at indicated time points.

  28. Ctau following administration of GSK3228836- All participants [From Week 1 to Week 25]

    Blood samples will be collected for PK analysis of GSK3228836 at indicated time points.

  29. Ctau following administration of nucleos(t)ide therapy- All participants [From Week 1 to Week 25]

    Blood samples will be collected for PK analysis of nucleos(t)ide at indicated time points

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • At least 18 years of age at the time of signing the informed consent.

  • Participants who have documented chronic HBV infection greater than equal to (>=6) months prior to screening and not currently on nucleos(t)ide analogue therapy population defined as participants who never received HBV treatment (treatment naive) or must have ended nucleos(t)ide therapy at least 6 months prior to the screening visit; OR Currently receiving stable nucleos(t)ide analogue therapy population defined as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study.

  • Plasma or serum HBsAg concentration >100 international units per milliliter (IU/mL).

  • Plasma or serum HBV DNA concentration: Participants not currently on nucleos(t)ide analogue therapy, plasma or serum HBV DNA >2000 IU/mL; Participants who are receiving stable nucleos(t)ide analogue therapy must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.

  • ALT for treatment naive participants and for participants who are not currently receiving treatment: ALT <3 times ULN will be included initially if agreed by the independent data monitoring committee (IDMC) after review of safety data, the ALT inclusion criteria may be expanded to include participants with ALT <5 times ULN; ALT less than equal to (<=2) times ULN for participants who are receiving stable nucleos(t)ide analogue therapy.

  • Male and/or Female: A male participant is eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: Refrain from donating sperm AND be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or Must agree to use contraception/barrier as detailed below: Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. A female participant is eligible to participate: If she is not pregnant or breastfeeding AND at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1 percent per year), preferably with low user dependency during the intervention period and for at least 90 days after the last dose of study treatment; A WOCBP must have both a confirmed menstrual period prior to the first dose of study intervention (additional evaluation [e.g., amenorrhea in athletes, birth control] should also be considered) and a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study treatment.

  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

  • Capable of giving signed informed consent.

Exclusion Criteria:
  • Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy) or physical examination.

  • Co-infection with Current or past history of Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), Hepatitis D virus (HDV).

  • History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by both Aspartate aminotransferase (AST)-Platelet Index (APRI) >2 and FibroSure/FibroTest result >0.7. If only one parameter (APRI or FibroSure/FibroTest) result is positive, a discussion with the Medical Monitor is required before inclusion in study is permitted. Regardless of APRI of Fibrosure/FibroTest score, if the participant meets one of the following criteria, they will be excluded from the study: Liver biopsy (i.e., Metavir Score F4); Liver stiffness >12 kilopascals (kPa).

  • Diagnosed or suspected hepatocellular carcinoma as evidenced by the following: Alpha-fetoprotein concentration >=200 nanogram per milliliter (ng/mL); If the screening alpha fetoprotein concentration is >=50 ng/mL and <200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization.

  • History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.

  • History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).

  • History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).

  • Anti-neutrophil cytoplasmic antibodies (ANCA) at screening by itself won't be an exclusion criterion, but if results are borderline positive or positive: myeloperoxidase-ANCA (MPO-ANCA) (Perinuclear antineutrophil cytoplasmic antibodies [pANCA]) and proteinase 3- ANCA (PR3-ANCA) (Cytoplasmic antineutrophil cytoplasmic antibodies [cANCA]) analysis will be conducted; A discussion with the Medical Monitor will be required to review participant's complete medical history to ensure no past history or current manifestations of a vasculitic/inflammatory/auto-immune condition before inclusion in study is permitted.

  • Low complement C3 (C3) at screening by itself won't be an exclusion criterion, but if it is present: A discussion with the Medical Monitor is required to review participant's complete medical history to ensure no past history or current manifestations of vasculitic/inflammatory/auto-immune conditions.

  • History of alcohol or drug abuse/dependence: Current alcohol use as judged by investigator to potentially interfere with participant compliance; History of or current drug abuse/dependence as judged by the investigator to potentially interfere with participant compliance. Refers to illicit drugs and substances with abuse potential. Medications that are used by the participant as directed, whether over-the-counter or through prescription, are acceptable and would not meet the exclusion criteria.

  • Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use.

  • Participants for whom immunosuppressive treatment is not advised, including therapeutic doses of steroids, will be excluded.

  • Currently taking, or took within 12 months of screening, any interferon-containing therapy.

  • Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors or anti-platelet agents like clopidogrel).

  • The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study treatment (whichever is longer) or 90 days (if half-life or duration is unknown).

  • Prior treatment with any oligonucleotide or small interfering ribonucleic acid (RNA) (Small interfering RNA [siRNA]) within 12 months prior to the first dosing day.

  • Fridericia's QT correction formula (QTcF) >=450 milliseconds (msec) (if single electrocardiogram [ECG] at screening shows QTcF>=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).

  • Laboratory results as follows: Serum albumin <3.5 grams per deciliter (g/dL), Glomerular filtration rate (GFR) <60 milliliter per minute per 1.73 square meter (mL/min /1.73 m^2) as calculated by the Chronic Kidney Disease Epidemiologic Collaboration (CKD-EPI) formula (for Japan, Japanese Society of Nephrology Chronic Kidney Disease Initiative [JSN-CKDI equation]), International normalized ratio (INR)

1.25. Platelet count <140 times 10^9 cells/L, Total bilirubin >1.25 times ULN. For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25 times ULN, discussion for inclusion to the study is required with the Medical Monitor, Urine albumin to creatinine ratio (ACR) >=0.03 mg/mg (or >=30 mg/g). In the event of an ACR above this threshold, eligibility may be confirmed by a second measurement. In cases where participants have low urine albumin and low urine creatinine levels resulting in a urine ACR calculation >=0.03 mg/mg (or >=30 mg/g), the investigator should confirm that the participant does not have a history of diabetes, hypertension or other risk factors that may affect renal function and discuss with the Medical Monitor, or designee.

  • History of/sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Los Angeles California United States 90089
2 GSK Investigational Site Miami Florida United States 33125
3 GSK Investigational Site Miami Florida United States 33136
4 GSK Investigational Site Decatur Georgia United States 30033
5 GSK Investigational Site Boston Massachusetts United States 02114
6 GSK Investigational Site New York New York United States 10016
7 GSK Investigational Site Pittsburgh Pennsylvania United States 15213
8 GSK Investigational Site Richmond Virginia United States 23249
9 GSK Investigational Site Ciudad Autonoma de Buenos Aires Buenos Aires Argentina C1181ACH
10 GSK Investigational Site Buenos Aires Argentina C1280AEB
11 GSK Investigational Site Sliven Bulgaria 8800
12 GSK Investigational Site Sofia Bulgaria 1431
13 GSK Investigational Site Sofia Bulgaria 1463
14 GSK Investigational Site Sofia Bulgaria 1527
15 GSK Investigational Site Calgary Alberta Canada T2N 4Z6
16 GSK Investigational Site Victoria British Columbia Canada V8V 3M9
17 GSK Investigational Site London Ontario Canada N6A 2C2
18 GSK Investigational Site Toronto Ontario Canada M5G 2C4
19 GSK Investigational Site Montreal Quebec Canada H2L 4E9
20 GSK Investigational Site Regina Saskatchewan Canada S4P 0W5
21 GSK Investigational Site Québec Canada G1V 4G2
22 GSK Investigational Site Wuhan Hubei China 430030
23 GSK Investigational Site Shenyang Liaoning China 110022
24 GSK Investigational Site Chongqing Sichuan China 400042
25 GSK Investigational Site Beijing China 100015
26 GSK Investigational Site Beijing China 100034
27 GSK Investigational Site Beijing China 100050
28 GSK Investigational Site Guangzhou China 510000
29 GSK Investigational Site Shanghai China 200025
30 GSK Investigational Site Clichy Cedex France 92118
31 GSK Investigational Site Créteil cedex France 94010
32 GSK Investigational Site Limoges cedex France 87042
33 GSK Investigational Site Lyon cedex 04 France 69317
34 GSK Investigational Site Nice cedex 3 France 06202
35 GSK Investigational Site Strasbourg France 67200
36 GSK Investigational Site Erlangen Bayern Germany 91054
37 GSK Investigational Site Frankfurt am Main Hessen Germany 60590
38 GSK Investigational Site Frankfurt Hessen Germany 60596
39 GSK Investigational Site Berlin Germany 10439
40 GSK Investigational Site Hamburg Germany 20146
41 GSK Investigational Site Pokfulam Hong Kong
42 GSK Investigational Site Modena Emilia-Romagna Italy 41126
43 GSK Investigational Site Milano Lombardia Italy 20122
44 GSK Investigational Site Milano Lombardia Italy 20132
45 GSK Investigational Site Milano Lombardia Italy 20157
46 GSK Investigational Site Ehime Japan 790-8524
47 GSK Investigational Site Hiroshima Japan 730-8619
48 GSK Investigational Site Hiroshima Japan 734-8551
49 GSK Investigational Site Hokkaido Japan 080-0024
50 GSK Investigational Site Ishikawa Japan 920-8650
51 GSK Investigational Site Ishikawa Japan 924-8588
52 GSK Investigational Site Kagawa Japan 760-8557
53 GSK Investigational Site Kumamoto Japan 860-8556
54 GSK Investigational Site Kumamoto Japan 862-8655
55 GSK Investigational Site Miyagi Japan 980-8574
56 GSK Investigational Site Nagasaki Japan 856-8562
57 GSK Investigational Site Osaka Japan 565-0871
58 GSK Investigational Site Tokyo Japan 113-8603
59 GSK Investigational Site Tokyo Japan 180-8610
60 GSK Investigational Site Busan Korea, Republic of 47392
61 GSK Investigational Site Busan Korea, Republic of 49241
62 GSK Investigational Site Daegu Korea, Republic of 41944
63 GSK Investigational Site Gyeonggi-do Korea, Republic of 15355
64 GSK Investigational Site Incheon Korea, Republic of 21565
65 GSK Investigational Site Seoul Korea, Republic of 03080
66 GSK Investigational Site Seoul Korea, Republic of 05505
67 GSK Investigational Site Seoul Korea, Republic of 06973
68 GSK Investigational Site Ulsan Korea, Republic of 44033
69 GSK Investigational Site Kuala Lumpur Malaysia 59100
70 GSK Investigational Site Makati City Philippines 1229
71 GSK Investigational Site Quezon City Philippines 1101
72 GSK Investigational Site Lancut Poland 37-100
73 GSK Investigational Site Lublin Poland 20-884
74 GSK Investigational Site Myslowice Poland 41-400
75 GSK Investigational Site Warszawa Poland 00-332
76 GSK Investigational Site Brasov Romania 500283
77 GSK Investigational Site Bucharest Romania 030303
78 GSK Investigational Site Cluj Napoca Romania 400162
79 GSK Investigational Site Cluj-Napoca Romania 400139
80 GSK Investigational Site Craiova Romania 200515
81 GSK Investigational Site Galati Romania 800179
82 GSK Investigational Site Iasi Romania 700116
83 GSK Investigational Site Timisoara Romania 300310
84 GSK Investigational Site Chelyabinsk Russian Federation 454052
85 GSK Investigational Site Kaliningrad Russian Federation 236016
86 GSK Investigational Site Krasnodar Russian Federation 350000
87 GSK Investigational Site Krasnojarsk Russian Federation 660049
88 GSK Investigational Site Moscow Russian Federation 121170
89 GSK Investigational Site Moscow Russian Federation 125008
90 GSK Investigational Site Novosibirsk Russian Federation 630005
91 GSK Investigational Site Novosibirsk Russian Federation 630099
92 GSK Investigational Site Saint-Petersburg Russian Federation 191167
93 GSK Investigational Site Samara Russian Federation 443063
94 GSK Investigational Site St. Petersburg Russian Federation 190103
95 GSK Investigational Site Singapore Singapore 119074
96 GSK Investigational Site Singapore Singapore 169608
97 GSK Investigational Site Singapore Singapore 529889
98 GSK Investigational Site Port Elizabeth Eastern Cape South Africa 6001
99 GSK Investigational Site Ennerdale Gauteng South Africa 1830
100 GSK Investigational Site Lenasia Johannesburg Gauteng South Africa 1827
101 GSK Investigational Site Durban KwaZulu- Natal South Africa 4052
102 GSK Investigational Site Kwaguqa Emalahleni Mpumalanga South Africa 1039
103 GSK Investigational Site Vosloorus Ext 2 South Africa 1475
104 GSK Investigational Site Barcelona Spain 08035
105 GSK Investigational Site Barcelona Spain 08036
106 GSK Investigational Site Madrid Spain 28029
107 GSK Investigational Site Madrid Spain 28031
108 GSK Investigational Site Majadahonda (Madrid) Spain 28222
109 GSK Investigational Site Málaga Spain 29010
110 GSK Investigational Site Santander Spain 39008
111 GSK Investigational Site Sevilla Spain 41013
112 GSK Investigational Site Changhua Taiwan 500
113 GSK Investigational Site Taichung Taiwan 40447
114 GSK Investigational Site Bangkok Thailand 10330
115 GSK Investigational Site Bangkok Thailand 10400
116 GSK Investigational Site Chiangmai Thailand 50200
117 GSK Investigational Site Phitsanulok Thailand 65000
118 GSK Investigational Site Songkla Thailand 9110
119 GSK Investigational Site London United Kingdom WC1E 6JB
120 GSK Investigational Site Newcastle-upon-Tyne United Kingdom NE7 7DN
121 GSK Investigational Site Plymouth United Kingdom PL6 8DH

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT04449029
Other Study ID Numbers:
  • 209668
First Posted:
Jun 26, 2020
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2022