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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02966834


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT02966834
Ethics application status
Date submitted
15/11/2016
Date registered
17/11/2016
Date last updated
10/07/2019

Titles & IDs
Public title
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis
Scientific title
A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)
Secondary ID [1] 0 0
2016-002416-41
Secondary ID [2] 0 0
201000
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholestasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - GSK2330672

Placebo Comparator: Placebo - Subjects will receive matching placebo

Experimental: GSK2330672 20 mg once daily - Subjects will receive GSK2330672 and matching placebo to maintain blind

Experimental: GSK2330672 90 mg once daily - Subjects will receive GSK2330672 and matching placebo to maintain blind

Experimental: GSK2330672 180 mg once daily - Subjects will receive GSK2330672 and matching placebo to maintain blind

Experimental: GSK2330672 90 mg twice daily - Subjects will receive GSK2330672 and matching placebo to maintain blind


Treatment: Drugs: Placebo
GSK2330672 matching placebo will be supplied as white film-coated tablets.

Treatment: Drugs: GSK2330672
GSK2330672 will be supplied in 2 dose strengths of 10 mg and 45 mg white film-coated tablets.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change from Baseline at Week 16 in the Mean Worst Daily Itch Score - Participant's itch severity is recorded on an electronic diary (eDiary) each morning and evening using a 0 to 10 numerical rating scale (NRS). The Worst Daily Itch Score is averaged over the 7 days preceding Baseline and over the 7 days preceding Week 16.
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Mean change from Baseline at Week 16 in PBC-40 scale - The PBC-40 is a disease specific health related quality of life measure.
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Mean change from Baseline at Week 16 in serum alkaline phosphatase (ALP) concentrations, in participants with high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67x upper limit of normal range (ULN) and/or total bilirubin concentrations >ULN at Day 1.
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Number of participants with serum ALP concentrations <1.67xULN and total bilirubin concentrations =<ULN at Week 16, among those with a high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67xULN and/or total bilirubin concentrations >ULN at Day 1
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Mean change from Baseline at Week 16 in serum alanine aminotransferase (ALT)among those with a high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67xULN and/or total bilirubin concentrations >ULN at Day 1
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Mean change from Baseline at Week 16 in serum aspartate aminotransferase (AST) among those with a high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67xULN and/or total bilirubin concentrations >ULN at Day 1
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Mean change from Baseline at Week 16 in serum gamma glutamyl transferase (GGT), among those with a high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67xULN and/or total bilirubin concentrations >ULN at Day 1
Timepoint [6] 0 0
Baseline and Week 16
Secondary outcome [7] 0 0
Mean change from Baseline at Week 16 in total bilirubin concentration, among those with a high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67xULN and/or total bilirubin concentrations >ULN at Day 1
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Mean change from Baseline at Week 16 in albumin concentration, among those with a high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67xULN and/or total bilirubin concentrations >ULN at Day 1
Timepoint [8] 0 0
Baseline and Week 16
Secondary outcome [9] 0 0
Mean change from Baseline at Week 16 in prothrombin time/international normalised ratio (PT/INR), among those with a high risk of PBC progression - Criteria for high risk of PBC progression is defined as serum ALP concentrations >=1.67xULN and/or total bilirubin concentrations >ULN at Day 1
Timepoint [9] 0 0
Baseline and Week 16
Secondary outcome [10] 0 0
Number of participants with any adverse event (AE) or serious adverse event (SAE) - An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
Timepoint [10] 0 0
Up to Week 20
Secondary outcome [11] 0 0
Number of participants with abnormal clinical chemistry parameters, as a measure of safety - Blood samples will be collected to measure blood urea nitrogen, creatinine, estimated glomerular filtration rate (eGFR-chronic kidney disease epidemiology collaboration [CKD-EPI]), glucose (fasting), total cholesterol (fasting), potassium, sodium, calcium, direct low density lipoprotein (LDL) cholesterol (fasting), triglycerides (fasting), AST, ALT, ALP, GGT, total bilirubin, direct bilirubin, total protein, and albumin
Timepoint [11] 0 0
Up to Week 20
Secondary outcome [12] 0 0
Number of subjects with abnormal hematology laboratory parameters, as a measure of safety - Blood samples will be collected to measure platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, percent reticulocytes, mean cell volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils
Timepoint [12] 0 0
Up to Week 20
Secondary outcome [13] 0 0
Electrocardiogram (ECG) assessment as a measure of safety - Single 12-lead ECG will be obtained to measure PR, QRS, QT, and Corrected QT interval
Timepoint [13] 0 0
Up to Week 20
Secondary outcome [14] 0 0
Blood pressure assessment as a measure of safety - Systolic and diastolic blood pressure will be measured after 5 minutes rest in a quiet setting without distractions
Timepoint [14] 0 0
Up to Week 20
Secondary outcome [15] 0 0
Measurement of heart rate as a measure of safety - Pulse rate will be measured after 5 minutes rest in a quiet setting without distractions
Timepoint [15] 0 0
Up to Week 20
Secondary outcome [16] 0 0
Gastrointestinal Symptom Rating Scale (GSRS) assessment - The GSRS is a validated scale that will be used to assess gastrointestinal symptoms experienced by participants
Timepoint [16] 0 0
Up to Week 20
Secondary outcome [17] 0 0
Number of participants with Mean Worst Daily Itch Score of <4 at Week 16 - Participant's itch severity is recorded on an eDiary each morning and evening using a 0 to 10 NRS.
Timepoint [17] 0 0
Week 16
Secondary outcome [18] 0 0
Number of participants with at least a 30% reduction from Baseline in the Mean Worst Daily Itch Score at Week 16 - Participant's itch severity is recorded on an eDiary each morning and evening using a 0 to 10 NRS.
Timepoint [18] 0 0
Baseline and Week 16
Secondary outcome [19] 0 0
Number of participants with at least a 2-point reduction from Baseline in the Mean Worst Daily Itch Score at Week 16 - Participant's itch severity is recorded on an eDiary each morning and evening using a 0 to 10 NRS.
Timepoint [19] 0 0
Baseline and Week 16
Secondary outcome [20] 0 0
Mean number of days with Worst Daily Itch Score of <4 - Participant's itch severity is recorded on an eDiary each morning and evening using a 0 to 10 NRS.
Timepoint [20] 0 0
Baseline to Week 16
Secondary outcome [21] 0 0
Mean number of days with Worst Daily Itch Score at least 30% lower than the Baseline Mean Worst Daily Itch Score - Participant's itch severity is recorded on an eDiary each morning and evening using a 0 to 10 NRS.
Timepoint [21] 0 0
Baseline to Week 16
Secondary outcome [22] 0 0
Mean number of days with Worst Daily Itch Score at least 2-points lower than the Baseline Mean Daily Score - Participant's itch severity is recorded on an eDiary each morning and evening using a 0 to 10 NRS.
Timepoint [22] 0 0
Baseline to Week 16
Secondary outcome [23] 0 0
Change from Baseline in the Mean Daily Sleep Score at Week 16 - Participant's quality of sleep will be recorded on an eDiary each morning using a 0 to 10 NRS. The Daily Sleep Score is averaged over the 7 days preceding Baseline and over the 7 days preceding Week 16
Timepoint [23] 0 0
Baseline and Week 16
Secondary outcome [24] 0 0
Change from Baseline in the Mean Daily Fatigue Score at Week 16 - Participant's fatigue level will be recorded on an eDiary each evening using a 0 to 10 NRS. The Daily Fatigue Score is averaged over the 7 days preceding Baseline and over the 7 days preceding Week 16
Timepoint [24] 0 0
Baseline and Week 16
Secondary outcome [25] 0 0
Change from Baseline in the 5-D Itch Scale at Week 16 - 5-D Itch Scale is measurement of participant's itch.
Timepoint [25] 0 0
Baseline and Week 16
Secondary outcome [26] 0 0
Mean change from Baseline at Week 16 in serum total bile acid concentration - Blood samples will be collected for evaluating total bile acid concentration as a biomarker of PBC
Timepoint [26] 0 0
Baseline and Week 16
Secondary outcome [27] 0 0
Mean change from Baseline at Week 16 in serum 7-alpha hydroxy-4-cholesten-3-one (C4) - Blood samples will be collected for evaluating C4 concentration as a marker of bile acid synthesis
Timepoint [27] 0 0
Baseline and Week 16
Secondary outcome [28] 0 0
Plasma concentration of GSK2330672 after sparse sampling - Blood samples will be collected for measurement of plasma GSK2330672 concentration
Timepoint [28] 0 0
Week 8 and Week 12 (Between 1 and 3 hours post-dose, and between 5 and 8 hours post-dose)

Eligibility
Key inclusion criteria
Inclusion Criteria

- Participant must be 18 to 80 years of age inclusive, at the time of signing the
informed consent.

- Participants who have proven PBC, as demonstrated by having at least 2 of the
following: History of sustained increased ALP levels >ULN first recognized at least 6
months prior to the Screening Visit (Sustained ALP elevations at the time of Screening
is not required, recognizing that the ALP may have decreased after institution of
ursodeoxycholic acid (UDCA) therapy as described in inclusion number 4). Documented
positive anti-mitochondrial antibody (AMA) titer (>1:40 titer on immunofluorescence or
M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear
antibodies (antinuclear dot and/or nuclear rim positive). Liver biopsy (at any time in
the past) consistent with PBC.

- Participants must rate their itch severity as being >=4 on a 0 to 10 point scale for
the majority of time (at least half the days, as recalled by the participant) during
the 8 weeks prior to the Screening Visit. Periods of low itch or no itch are
acceptable as long as the worst daily itch score is >=4 on the majority of days.

- Participants who are currently taking UDCA should be on stable doses of UDCA for >8
weeks at time of screening. Participants not taking UDCA due to intolerance may be
enrolled 8 weeks after their last dose of UDCA. No changes or discontinuation is
permitted until completion of the Main Study Period.

- Male and/or female: Female participants- A female participant is eligible to
participate if she is not pregnant, not breastfeeding, and at least one of the
following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP
who agrees to follow the contraceptive guidance during the treatment period and until
at least 4 weeks after the last dose of study treatment.

- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Screening total bilirubin >2x ULN. Total bilirubin >2x ULN is acceptable if bilirubin
is fractionated and direct bilirubin <35%.

- Screening ALT or AST >6x ULN.

- Screening eGFR <45 milliliter (mL)/minute/1.73 meter squared (m^2) based on the
CKD-EPI.

- History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy
or ascites).

- Presence of actively replicating viral hepatitis due to hepatitis B or C (HBV, HCV)
infection, and/or confirmed hepatocellular carcinoma or biliary cancer. Other hepatic
conditions ( e.g., primary sclerosing cholangitis [PSC], alcoholic liver disease,
autoimmune hepatitis, non-alcoholic steatohepatitis [NASH] ) are permitted if PBC is
the dominant liver injury in the investigator's opinion.

- Current diarrhea.

- Current symptomatic cholelithiasis or inflammatory gall bladder disease. Participants
with history of cholecystectomy >=3 months before screening may be eligible for
enrolment.

- Any current medical condition (e.g. psychiatric disorder, senility or dementia), which
may affect the participant's ability to comply with the protocol specified procedures.

- Initiation or increase in dose of colchicine, methotrexate, azathioprine, or systemic
corticosteroids in the 2 months prior to screening. If a change in dose in any of
these medications is anticipated during the course of the study, the participant
should be excluded.

- Initiation or increase in dose of bezafibrate or fenofibrate at any time during the 3
months prior to screening. Participants may join the study on stable doses of these
medications, but no change or discontinuation is permitted until completion of the
Main Study Period.

- Initiation or increase in dose of any of the following in the 8 weeks prior to
screening: rifampicin, naltrexone, naloxone, nalfurafine, or sertraline. Participants
may join the study on stable or decreased doses of these medications, but no change in
dose is permitted until completion of the Main Study Period.

- Bile acid binding resin use: a participant must discontinue use of cholestyramine,
colesevelam, colestipol or colestimide prior to the start of the Initial Study Period
(no later than Day-2). Note: these drugs may be administered after completion of the
Main Study Period, if clinically indicated.

- Obeticholic acid use: a participant must discontinue use of obeticholic acid at least
8 weeks prior to the start of the Initial Study Period and may not restart until after
the end of the study.

- Administration of any other IBAT inhibitor in the 3 months prior to screening.

- Current enrolment or participation within the 8 weeks before start of the Initial
Study Period, in any other clinical study involving an investigational study
treatment.

- QT interval corrected for heart rate QTc >480 millisecond (msec).

- History of sensitivity to the study treatment or components thereof or a history of
drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor,
contraindicates their participation in the study.

- History of regular alcohol consumption within 6 months of the study defined as an
average weekly intake of >21 units for males or >14 units for females. One unit is
equivalent to 8 gram of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of
wine or 1 measure (25 mL) of spirits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Herston
Recruitment hospital [3] 0 0
GSK Investigational Site - Prahran
Recruitment hospital [4] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Manitoba
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
France
State/province [13] 0 0
Clermont-Ferrand
Country [14] 0 0
France
State/province [14] 0 0
Grenoble Cedex 9
Country [15] 0 0
France
State/province [15] 0 0
Lille cedex
Country [16] 0 0
France
State/province [16] 0 0
Paris cedex 12
Country [17] 0 0
France
State/province [17] 0 0
Pessac cedex
Country [18] 0 0
Germany
State/province [18] 0 0
Baden-Wuerttemberg
Country [19] 0 0
Germany
State/province [19] 0 0
Bayern
Country [20] 0 0
Germany
State/province [20] 0 0
Hessen
Country [21] 0 0
Germany
State/province [21] 0 0
Hamburg
Country [22] 0 0
Italy
State/province [22] 0 0
Emilia-Romagna
Country [23] 0 0
Italy
State/province [23] 0 0
Lombardia
Country [24] 0 0
Italy
State/province [24] 0 0
Toscana
Country [25] 0 0
Italy
State/province [25] 0 0
Veneto
Country [26] 0 0
Japan
State/province [26] 0 0
Chiba
Country [27] 0 0
Japan
State/province [27] 0 0
Fukui
Country [28] 0 0
Japan
State/province [28] 0 0
Gunma
Country [29] 0 0
Japan
State/province [29] 0 0
Hiroshima
Country [30] 0 0
Japan
State/province [30] 0 0
Hokkaido
Country [31] 0 0
Japan
State/province [31] 0 0
Kagawa
Country [32] 0 0
Japan
State/province [32] 0 0
Kanagawa
Country [33] 0 0
Japan
State/province [33] 0 0
Nagasaki
Country [34] 0 0
Japan
State/province [34] 0 0
Osaka
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Poland
State/province [36] 0 0
Czestochowa
Country [37] 0 0
Poland
State/province [37] 0 0
Katowice
Country [38] 0 0
Poland
State/province [38] 0 0
Myslowice
Country [39] 0 0
Poland
State/province [39] 0 0
Warszawa
Country [40] 0 0
Poland
State/province [40] 0 0
Wroclaw
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Santander
Country [44] 0 0
Spain
State/province [44] 0 0
Sevilla
Country [45] 0 0
Spain
State/province [45] 0 0
Valencia
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Basingstoke
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Edgbaston
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Glasgow
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Liverpool.
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Manchester
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Middlesbrough
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Newcastle-upon-Tyne
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Nottingham
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Plymouth
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672
administration for the treatment of pruritus (itch) in participants with primary biliary
cholangitis (PBC). Participants will be treated with either placebo or one of the 4 dose
regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice
daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding. The
total duration of a subject's participation will be up to 45 days of screening and 24 weeks
of study including follow-up.
Trial website
https://clinicaltrials.gov/show/NCT02966834
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02966834

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,QLD,WA
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
GlaxoSmithKline
Primary sponsor address
Primary sponsor country
Ethics approval
Ethics application status
Approved
 
Public notes
Investigators:
Richard Skoien, Royal Brisbane and Women's Hospital, Queensland, Herston, Australia, 4029
Simone Strasser, Royal Prince Alfred Hospital, New South Wales, Camperdown, Australia, 2050
George Garas, Sir Charles Gairdner Hospital, Western Australia, Nedlands, Australia, 6009

Contacts
Principal investigator
Title 69 0
Name 69 0
Address 69 0
Country 69 0
Phone 69 0
Fax 69 0
Email 69 0
Contact person for public queries
Title 70 0
Name 70 0
Address 70 0
Country 70 0
Phone 70 0
Fax 70 0
Email 70 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries
Title 71 0
Name 71 0
Address 71 0
Country 71 0
Phone 71 0
Fax 71 0
Email 71 0
GSKClinicalSupportHD@gsk.com