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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03069352




Registration number
NCT03069352
Ethics application status
Date submitted
28/02/2017
Date registered
3/03/2017

Titles & IDs
Public title
A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
Scientific title
A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
Secondary ID [1] 0 0
2016-003900-30
Secondary ID [2] 0 0
M16-043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Venetoclax
Treatment: Drugs - Cytarabine

Experimental: Venetoclax + Low Dose Cytarabine (LDAC) - Venetoclax 600 mg orally every day (QD) plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Placebo comparator: Placebo + LDAC - Matching placebo to venetoclax orally QD plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.


Treatment: Drugs: Placebo
tablet

Treatment: Drugs: Venetoclax
tablet

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

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
Secondary outcome [1] 0 0
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)
Timepoint [1] 0 0
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Secondary outcome [2] 0 0
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh)
Timepoint [2] 0 0
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Secondary outcome [3] 0 0
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2
Timepoint [3] 0 0
Cycle 1, 28 days
Secondary outcome [4] 0 0
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2
Timepoint [4] 0 0
Cycle 1, 28 days
Secondary outcome [5] 0 0
Percentage of Participants With Complete Remission
Timepoint [5] 0 0
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Secondary outcome [6] 0 0
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a
Timepoint [6] 0 0
Baseline and Day 1 of Cycles 3, 5, 7, and 9
Secondary outcome [7] 0 0
Change From Baseline in Global Health Status / Quality of Life
Timepoint [7] 0 0
Baseline and Day 1 of Cycles 3, 5, 7, and 9
Secondary outcome [8] 0 0
Event-free Survival (EFS)
Timepoint [8] 0 0
From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
Secondary outcome [9] 0 0
Percentage of Participants With Post Baseline Red Blood Cell (RBC) Transfusion Independence
Timepoint [9] 0 0
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Secondary outcome [10] 0 0
Percentage of Participants With Post Baseline Platelet Transfusion Independence
Timepoint [10] 0 0
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Secondary outcome [11] 0 0
Percentage of Participants With RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline
Timepoint [11] 0 0
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Secondary outcome [12] 0 0
Percentage of Participants With Platelet Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline
Timepoint [12] 0 0
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Secondary outcome [13] 0 0
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) and Minimal Residual Disease (MRD) Response
Timepoint [13] 0 0
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Secondary outcome [14] 0 0
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) and Minimal Residual Disease (MRD) Response
Timepoint [14] 0 0
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Secondary outcome [15] 0 0
Overall Survival (OS) by Mutation Subgroups
Timepoint [15] 0 0
From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
Secondary outcome [16] 0 0
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Mutation Subgroup
Timepoint [16] 0 0
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Secondary outcome [17] 0 0
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup
Timepoint [17] 0 0
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

Eligibility
Key inclusion criteria
1. Participant must have histological confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, be ineligible for intensive induction chemotherapy and either be:

* = 75 years of age OR
* = 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy:

* Eastern Cooperative Oncology Group (ECOG) performance status of 2 - 3
* Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction = 50% or chronic stable angina
* Diffusing capacity of the lung for carbon monoxide (DLCO) = 65% or forced expiratory volume in 1 second (FEV1) = 65%
* Creatinine clearance = 30 mL/min to < 45 ml/min
* Moderate hepatic impairment with total bilirubin > 1.5 to = 3.0 × upper limit of normal (ULN)
* Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment
2. Participant must have an ECOG performance status:

* of 0 to 2 for subjects = 75 years of age OR
* of 0 to 3 for subjects between 18 to 74 years of age
3. Participant must have a projected life expectancy of at least 12 weeks.
4. Participant must have adequate renal function as demonstrated by a creatinine clearance = 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
5. Participant must have adequate liver function as demonstrated by:

* aspartate aminotransferase (AST) = 3.0 × ULN*
* alanine aminotransferase (ALT) = 3.0 × ULN*
* bilirubin = 1.5 × ULN*

* Subjects who are < 75 years of age may have bilirubin of = 3.0 × ULN

(*Unless considered to be due to leukemic organ involvement.)
6. Female participants must be either postmenopausal defined as:

* Age > 55 years with no menses for 12 or more months without an alternative medical cause.
* Age = 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level > 40 IU/L.

OR
* Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).

OR
* A woman of childbearing potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
7. Male participants who are sexually active, must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
8. Females of childbearing potential must have negative results for pregnancy test performed:

* At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
* Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
* Subjects with borderline pregnancy tests at Screening must have a serum pregnancy test = 3 days later to document continued lack of a positive result.
9. Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for myelodysplastic syndrome is allowed except for use of cytarabine.
2. Participant had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL 1 translocation and AML with BCR-ABL 1 translocation.
3. Participants that have acute promyelocytic leukemia (APL).
4. Participant has known central nervous system (CNS) involvement with AML.
5. Participant has known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). HIV testing will be performed at Screening, if required per local guidelines or institutional standards.
6. Participant is known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals (non-exclusionary medications) are not excluded.
7. Participant has received strong or moderate cytochrome P450 3A4 (CYP3A) inducers 7 days prior to the initiation of study treatment.

* Chinese subjects are excluded from receiving strong and/or moderate CYP3A inhibitors 7 days prior to the initiation of study treatment through the end of intensive pharmacokinetic (PK) collection (24 hours post dose on Cycle 1 Day 10).
8. Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days prior to the initiation of study treatment.
9. Participant has cardiovascular disability status of New York Heart Association Class > 2. Class 2 is defined as cardiac disease which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain. Class 3 is defined as cardiac disease which subjects are comfortable at rest but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4 is defined as cardiac disease which subjects have an inability to carry on any physical activity without discomfort, symptoms of heart failure at rest, and if any physical activity is undertaken then discomfort increases.
10. Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of LDAC that in the opinion of the investigator would adversely affect his/her participating in this study.
11. Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
12. Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
13. Participant has a history of other malignancies prior to study entry, with the exception of:

* Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
14. Participant has a white blood cell count > 25 × 10^9/L. (Note: hydroxyurea administration or leukapheresis is permitted to meet this criterion).
15. Previous treatment with venetoclax and/or current participation in any other research study with investigational products.

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/07/2025
Actual
Sample size
Target
Accrual to date
Final
211
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle /ID# 160123 - Waratah
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 160121 - Westmead
Recruitment hospital [3] 0 0
Alfred Hospital /ID# 160125 - Melbourne
Recruitment hospital [4] 0 0
Box Hill Hospital /ID# 162920 - Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Cordoba
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Bruxelles-Capitale
Country [11] 0 0
Brazil
State/province [11] 0 0
Santa Catarina
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Paulo
Country [13] 0 0
Brazil
State/province [13] 0 0
Porto Alegre
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
China
State/province [16] 0 0
Fujian
Country [17] 0 0
China
State/province [17] 0 0
Guangdong
Country [18] 0 0
China
State/province [18] 0 0
Jiangsu
Country [19] 0 0
China
State/province [19] 0 0
Jilin
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
China
State/province [21] 0 0
Sichuan
Country [22] 0 0
China
State/province [22] 0 0
Tianjin
Country [23] 0 0
China
State/province [23] 0 0
Zhejiang
Country [24] 0 0
China
State/province [24] 0 0
Jinan
Country [25] 0 0
China
State/province [25] 0 0
Wuhan
Country [26] 0 0
China
State/province [26] 0 0
Zhengzhou, Henan
Country [27] 0 0
Czechia
State/province [27] 0 0
Brno
Country [28] 0 0
Czechia
State/province [28] 0 0
Ostrava
Country [29] 0 0
Czechia
State/province [29] 0 0
Prague
Country [30] 0 0
France
State/province [30] 0 0
Rhone
Country [31] 0 0
France
State/province [31] 0 0
Sarthe
Country [32] 0 0
France
State/province [32] 0 0
Bayonne
Country [33] 0 0
France
State/province [33] 0 0
Pessac
Country [34] 0 0
France
State/province [34] 0 0
Vandoeuvre Les Nancy Cedex
Country [35] 0 0
Germany
State/province [35] 0 0
Baden-Wuerttemberg
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Hamburg
Country [38] 0 0
Greece
State/province [38] 0 0
Attiki
Country [39] 0 0
Greece
State/province [39] 0 0
Alexandroupolis
Country [40] 0 0
Greece
State/province [40] 0 0
Athens
Country [41] 0 0
Greece
State/province [41] 0 0
Patras
Country [42] 0 0
Greece
State/province [42] 0 0
Thessaloniki
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Pecs
Country [45] 0 0
Hungary
State/province [45] 0 0
Debrecen
Country [46] 0 0
Hungary
State/province [46] 0 0
Gyor
Country [47] 0 0
Hungary
State/province [47] 0 0
Kaposvar
Country [48] 0 0
Hungary
State/province [48] 0 0
Kecskemét
Country [49] 0 0
Ireland
State/province [49] 0 0
Dublin
Country [50] 0 0
Ireland
State/province [50] 0 0
Galway
Country [51] 0 0
Ireland
State/province [51] 0 0
Limerick
Country [52] 0 0
Japan
State/province [52] 0 0
Fukui
Country [53] 0 0
Japan
State/province [53] 0 0
Fukuoka
Country [54] 0 0
Japan
State/province [54] 0 0
Gunma
Country [55] 0 0
Japan
State/province [55] 0 0
Ibaraki
Country [56] 0 0
Japan
State/province [56] 0 0
Kyoto
Country [57] 0 0
Japan
State/province [57] 0 0
Miyagi
Country [58] 0 0
Japan
State/province [58] 0 0
Nagasaki
Country [59] 0 0
Japan
State/province [59] 0 0
Osaka
Country [60] 0 0
Japan
State/province [60] 0 0
Tokyo
Country [61] 0 0
Japan
State/province [61] 0 0
Yamagata
Country [62] 0 0
Japan
State/province [62] 0 0
Akita
Country [63] 0 0
Japan
State/province [63] 0 0
Hidaka
Country [64] 0 0
Japan
State/province [64] 0 0
Nagoya
Country [65] 0 0
Japan
State/province [65] 0 0
Shimotsuga
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Busan Gwang Yeogsi
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Daejeon Gwang Yeogsi
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul Teugbyeolsi
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Seoul
Country [70] 0 0
Mexico
State/province [70] 0 0
Ciudad De Mexico
Country [71] 0 0
Mexico
State/province [71] 0 0
Michoacan
Country [72] 0 0
Mexico
State/province [72] 0 0
Nuevo Leon
Country [73] 0 0
New Zealand
State/province [73] 0 0
Auckland
Country [74] 0 0
Norway
State/province [74] 0 0
Hordaland
Country [75] 0 0
Norway
State/province [75] 0 0
Gralum
Country [76] 0 0
Puerto Rico
State/province [76] 0 0
San Juan
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Kemerovskaya Oblast
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Nizhegorodskaya Oblast
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Ryazanskaya Oblast
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Moscow
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Samara
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Sankt-peterburg
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Saratov
Country [84] 0 0
Russian Federation
State/province [84] 0 0
St. Petersburg
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Yaroslavl
Country [86] 0 0
South Africa
State/province [86] 0 0
Gauteng
Country [87] 0 0
Spain
State/province [87] 0 0
Valenciana
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taipei
Country [90] 0 0
Taiwan
State/province [90] 0 0
Kaohsiung
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Birmingham
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Cardiff
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Harrow

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03069352