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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03395184




Registration number
NCT03395184
Ethics application status
Date submitted
5/12/2017
Date registered
10/01/2018

Titles & IDs
Public title
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
Scientific title
A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE
Secondary ID [1] 0 0
2017-003359-43
Secondary ID [2] 0 0
B7981007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06651600 Placebo
Treatment: Drugs - PF-06651600
Treatment: Drugs - Placebo PF-06700841
Treatment: Drugs - PF-06700841

Experimental: PF-06700841 or placebo -

Experimental: PF-06651600 or placebo -


Treatment: Drugs: PF-06651600 Placebo
12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks

Treatment: Drugs: PF-06651600
200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks

Treatment: Drugs: Placebo PF-06700841
12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks

Treatment: Drugs: PF-06700841
60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving SES CD 50 (>50% reduction in SES CD from baseline) at Week 12.
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Number of subjects with adverse events
Timepoint [2] 0 0
Baseline of extension period (Week 12) to week 68
Primary outcome [3] 0 0
Number of subjects with serious adverse events
Timepoint [3] 0 0
Baseline of extension period (Week 12) to week 68
Primary outcome [4] 0 0
Number of subjects with electrocardiogram findings of potential clinical importance
Timepoint [4] 0 0
Baseline of extension period (Week 12) to week 68
Primary outcome [5] 0 0
Number of subjects with laboratory tests findings of potential clinical importance
Timepoint [5] 0 0
Baseline of extension period (Week 12) to week 68
Primary outcome [6] 0 0
Number of subjects withdrawal due to adverse events
Timepoint [6] 0 0
Baseline of extension period (Week 12) to week 68
Primary outcome [7] 0 0
Number of subjects with vital signs findings of potential clinical importance
Timepoint [7] 0 0
Baseline of extension period (Week 12) to week 68
Secondary outcome [1] 0 0
Number of participants with potentially clinically important serious infections findings
Timepoint [1] 0 0
64 weeks
Secondary outcome [2] 0 0
Mean change from baseline in SES-CD score at Week 12.
Timepoint [2] 0 0
Baseline, week 12
Secondary outcome [3] 0 0
Proportion of subjects achieving SES-CD 25 at Week 12.
Timepoint [3] 0 0
Baseline, week 12
Secondary outcome [4] 0 0
Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Proportion of subjects achieving mucosal healing at Week 12.
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Number of subjects with adverse events
Timepoint [6] 0 0
Baseline of induction period to week 12
Secondary outcome [7] 0 0
Number of subjects with serious adverse events
Timepoint [7] 0 0
Baseline of induction period to week 12
Secondary outcome [8] 0 0
Number of subjects with electrocardiogram findings of potential clinical importance.
Timepoint [8] 0 0
Baseline of induction period to week 12
Secondary outcome [9] 0 0
Number of subjects withdrawal due to adverse events
Timepoint [9] 0 0
Baseline of induction period to week 12
Secondary outcome [10] 0 0
Number of subjects with vital signs findings of potential clinical importance.
Timepoint [10] 0 0
Baseline of induction period to week 12
Secondary outcome [11] 0 0
Number of subjects with laboratory tests findings of potential clinical importance.
Timepoint [11] 0 0
Baseline of induction period to week 12
Secondary outcome [12] 0 0
Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.
Timepoint [12] 0 0
week 64
Secondary outcome [13] 0 0
Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.
Timepoint [13] 0 0
week 64
Secondary outcome [14] 0 0
Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of > or equal 3 points from baseline in SES CD score) at Week 12.
Timepoint [14] 0 0
Week 12

Eligibility
Key inclusion criteria
1. Male and/or female subjects 18 years to 75 years of age
2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.
3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.
4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.
5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:

•Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).
6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below:

* Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.
* Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.
* Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.
2. Presence of active (draining) fistulae or intra abdominal or perineal abscesses.
3. Strictures with obstructive symptoms.
4. Short bowel syndrome.
5. History of bowel perforation requiring surgical intervention within the past 12 months.
6. Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.
7. History of bowel surgery within 6 months prior to baseline.
8. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
9. Subjects with primary sclerosing cholangitis.
10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.
11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.
12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.
13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period:

1. >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
2. IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
3. Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.
4. Anti TNF inhibitors (or biosimilars thereof) as described below:

* Infliximab within 8 weeks prior to baseline;
* Adalimumab within 8 weeks prior to baseline;
* Certolizumab within 8 weeks prior to baseline;
5. Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.
6. Ustekinumab within 8 weeks prior to baseline.
7. Interferon therapy within 8 weeks prior to baseline.
8. Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).
9. Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.
10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.
12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.
13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.
14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.

14) Subjects with history of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability.

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 administering the treatment/s
The people assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2023
Sample size
Target
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [3] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [4] 0 0
Saint John of God Health Care Inc. - Subiaco
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3350 - Ballarat
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Belgium
State/province [16] 0 0
Jette
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liége
Country [19] 0 0
Bosnia and Herzegovina
State/province [19] 0 0
Banja Luka
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Croatia
State/province [21] 0 0
Split
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Croatia
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Zagreb
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Czechia
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Horovice
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Strakonice
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Georgia
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Tbilisi
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Germany
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Berlin
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Germany
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Kiel
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Szekszard
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Italy
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Bari
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Italy
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BS
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Italy
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CZ
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Italy
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MB
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Italy
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Milan
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Italy
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Messina
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Italy
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Padova
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Italy
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Roma
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Korea, Republic of
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Korea
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Korea, Republic of
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Seoul
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Lebanon
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Achrafieh
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Beirut
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El Chouf
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Lebanon
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Saida
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Poland
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Dolnoslaskie
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Sopot
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Sroda Wielkopolska
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Staszow
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Szczecin
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Warszawa
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Wloclawek
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Wroclaw
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Russian Federation
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Saint-petersburg
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Russian Federation
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Sestroretsk
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Russian Federation
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Stavropol Region
Country [70] 0 0
Russian Federation
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Udmurt Republic
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Stavropol
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Saudi Arabia
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Riyadh
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Serbia
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Beograd
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Serbia
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Srbija
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Slovakia
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Banska Bystrica
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Slovakia
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Vranov nad Toplou
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South Africa
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Gauteng
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South Africa
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Western CAPE
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Spain
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Cantabria
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
State/province [92] 0 0
Zürich
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Tunisia
State/province [93] 0 0
Tunis
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Turkey
State/province [94] 0 0
Ankara
Country [95] 0 0
Turkey
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Kocaeli
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Turkey
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Mersin
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Turkey
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Zonguldak
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Ukraine
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Chernivtsi
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Vinnytsia
Country [103] 0 0
Ukraine
State/province [103] 0 0
Zaporizhzhia
Country [104] 0 0
United Arab Emirates
State/province [104] 0 0
Dubai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03395184