The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04313881




Registration number
NCT04313881
Ethics application status
Date submitted
11/03/2020
Date registered
18/03/2020

Titles & IDs
Public title
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
Scientific title
ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome
Secondary ID [1] 0 0
2020-004287-26
Secondary ID [2] 0 0
5F9009
Universal Trial Number (UTN)
Trial acronym
ENHANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Experimental: Magrolimab + Azacitidine - Participants will receive the following magrolimab and azacitidine dosing regimens:

Magrolimab:

Magrolimab Priming Dose:

* 1 mg/kg on Days 1 and 4
* 15 mg/kg on Day 8
* 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50)

Magrolimab Maintenance Dose:

* 30 mg/kg on Day 57 and 30 mg/kg every 2 weeks thereafter.

Azacitidine: 75 mg/m\^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.

Placebo comparator: Control Arm (Placebo + Azacitidine) - Participants will receive the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine:

Placebo: On Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter.

Azacitidine: 75 mg/m\^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle.


Treatment: Drugs: Magrolimab
Administered intravenously

Treatment: Drugs: Azacitidine
Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling

Treatment: Drugs: Placebo
Placebo to match magrolimab administered intravenously

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Complete Remission (CR)
Assessment method [1] 0 0
The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of = 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off.
Timepoint [1] 0 0
From randomization up to 31.01 months
Primary outcome [2] 0 0
Overall Survival (OS)
Assessment method [2] 0 0
OS is defined as the number of months measured from the date of randomization to the date of death from any cause. Kaplan Meier (KM) estimates were used for analysis.
Timepoint [2] 0 0
From randomization up to 32.62 months
Secondary outcome [1] 0 0
Duration of CR (DOCR)
Assessment method [1] 0 0
DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. PD is defined as: \<5% blasts: =50 increase in blasts to \>5% blasts,5%-10% blasts: =50% increase in blasts to \>10% blasts, 10%-20% blasts: =50% increase in blasts to \>20% blasts,20%-30% blasts: =50% increase in blasts to \>30% blasts, any of the following: at least 50% decrement from maximum remission/response in granulocytes or platelets. Reduction in Hgb by =2 g/dL / Transfusion dependence. Relapse is defined as return to pretreatment bone marrow blast percentage / decrement of = 50% from maximum remission/response levels in granulocytes or platelets/ reduction in Hgb concentration by = 1.5 g/dL or transfusion dependence. CR is defined in outcome measure 1. KM estimates were used for analysis.
Timepoint [1] 0 0
From randomization up to 31.01 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Assessment method [2] 0 0
ORR is defined as the percentage of participants who reach objective response including CR, partial remission (PR), marrow CR or hematological improvement prior to initiation of any new anticancer therapy including SCT for MDS per IWG 2006 criteria per investigator's evaluation. CR is defined in outcome measure 1. PR is defined as all CR criteria if abnormal before treatment except, one marrow blasts decreased by = 50% over pretreatment but still \> 5% cellularity and morphology not relevant. Marrow CR is defined as bone marrow = 5% myeloblasts and decrease by = 50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for \> 8 weeks. Percentages were rounded off.
Timepoint [2] 0 0
From randomization up to 31.01 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Assessment method [3] 0 0
DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. Disease progression and relapse have been defined in outcome measure number 3. KM estimates were used for analysis.
Timepoint [3] 0 0
From randomization up to 31.01 months
Secondary outcome [4] 0 0
Red Blood Cell (RBC) Transfusion Independence Rate
Assessment method [4] 0 0
RBC transfusion independence rate is defined as the percentage of participants who have a 56-day or longer period with no RBC transfusions at any time between randomization and initiation of any new anticancer therapy, including SCT, among all participants who were RBC transfusion-dependent at Baseline. Percentages were rounded off.
Timepoint [4] 0 0
From randomization up to 31.01 months
Secondary outcome [5] 0 0
Event Free Survival (EFS)
Assessment method [5] 0 0
EFS is defined as the time from randomization to transformation to acute myeloid leukemia (AML) or death from any cause, whichever occurs first. Transformation assessments and deaths post SCT were included in the analysis. KM estimates were used for analysis
Timepoint [5] 0 0
From randomization up to 31.01 months
Secondary outcome [6] 0 0
Percentage of Participants With CR in Participants With TP53 Mutation
Assessment method [6] 0 0
CR in TP53 mutant population is defined as the percentage of participants who achieve a morphologic CR based on investigator assessments using IWG criteria on or prior to initiation of any new anticancer therapy, including SCT in TP53 mutant population. Percentages were rounded off.
Timepoint [6] 0 0
From randomization up to 31.01 months
Secondary outcome [7] 0 0
Minimal Residual Disease (MRD)-Negative Response Rate
Assessment method [7] 0 0
The MRD-negative response rate is defined as the percentage of participants who achieved a morphologic CR or marrow CR based on Investigator-assessed IWG criteria and reached MRD-negative disease status prior to initiation of any new anticancer therapy, including SCT. MRD-negative disease status was assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. Morphologic CR and marrow CR are defined in outcome measures 1 and 4, respectively. Percentages were rounded off.
Timepoint [7] 0 0
From randomization up to 31.01 months
Secondary outcome [8] 0 0
Time to Transformation to AML
Assessment method [8] 0 0
Time to transformation to AML is defined as the time from randomization to the collection date of bone marrow sample leading to documented AML diagnosis. Transformation assessments post SCT were included in the analysis.KM estimates were used for analysis.
Timepoint [8] 0 0
From randomization up to 31.01 months
Secondary outcome [9] 0 0
Progression Free Survival (PFS)
Assessment method [9] 0 0
PFS is defined as the time from randomization to the date of documented DP (including treatment failure by IWG criteria or relapse after PR/CR), or death from any cause, whichever occurs first. Response assessments and deaths post SCT were included in the analysis. Treatment failure is defined as, Death during treatment or disease progression characterized by worsening cytopenia, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment. Relapse after CR or PR = Return to pretreatment bone marrow blast percentage / Decrement of = 50% from maximum remission/response levels in granulocytes or platelets / Reduction in Hgb concentration by = 1.5 g/dL or transfusion dependence. CR, PR and PD are defined in outcome measures 1, 4 and 5 respectively. KM estimates were used for analysis.
Timepoint [9] 0 0
From randomization up to 31.01 months
Secondary outcome [10] 0 0
Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate
Assessment method [10] 0 0
The FACT-Anemia response rate is defined as the percentage of participants who showed clinically meaningful improvement in health-related quality of life (HRQoL) based on the score from the FACT-Anemia instrument prior to initiation of any new anticancer therapy, including SCT. The minimal clinically meaningful difference of 7.0 was used as cutoff for clinically meaningful improvement. The FACT-Anemia instrument consists of 5 subscales, including physical well-being, emotional well-being, functional well-being, social well-being, and anemia symptoms. Each subscale measures items on a 5-point Likert scale from 0 to 4, where 0 = not at all and 4 = very much. The subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest quality of life (QOL) and 100 denotes the highest QOL. Percentages were rounded off.
Timepoint [10] 0 0
Up to week 136
Secondary outcome [11] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Assessment method [11] 0 0
TEAE's are defined as any AEs with an onset date on or after the study drug start date, no later than 70 days after study drug last dose date or day before initiation of new anticancer therapy including SCT. If AE onset date is on or before last dose date, it is considered as TEAE regardless of start of new anticancer therapy. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution. An event is considered "serious", if it results death, life-threatening, inpatient or prolongation hospitalization, incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, and important medical events.
Timepoint [11] 0 0
First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years)
Secondary outcome [12] 0 0
Serum Concentration of Magrolimab
Assessment method [12] 0 0
Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of study treatment; thereafter, pretreatment assessments are to be collected within 24 hours prior to study treatment administration.
Timepoint [12] 0 0
Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336
Secondary outcome [13] 0 0
Percentage of Participants With Positive Anti-magrolimab Antibodies
Assessment method [13] 0 0
Percentages were rounded off.
Timepoint [13] 0 0
Up to 72 hours before administration of any treatment at Day 1, Cycle 1; within 24 hours prior to any study drug administration at Day 1 of Cycles 2, 3, 5, 7, 10, and 13 and End of Treatment (± 7 Days after last study drug dose); Cycle length is 28 Days

Eligibility
Key inclusion criteria
Key

* Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
* Adequate performance status and hematological, liver, and kidney function.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor.
* Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPa)-targeting agents.
* Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R.
* Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least = 1 year.
* Contraindications to azacitidine.
* Clinical suspicion of active central nervous system (CNS) involvement by MDS.
* Known active or chronic hepatitis B or C infection or human immunodeficiency virus in medical history .
* Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening.
* Pregnancy or active breastfeeding.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
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,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [8] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
Eastern Health - Box Hill
Recruitment hospital [10] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [11] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [12] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment hospital [13] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [14] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [15] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3199 - Frankston
Recruitment postcode(s) [12] 0 0
3220 - Geelong
Recruitment postcode(s) [13] 0 0
3144 - Malvern
Recruitment postcode(s) [14] 0 0
3004 - Melbourne
Recruitment postcode(s) [15] 0 0
3050 - Parkville
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Austria
State/province [26] 0 0
Salzburg
Country [27] 0 0
Austria
State/province [27] 0 0
Vienna
Country [28] 0 0
Belgium
State/province [28] 0 0
Antwerpen
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussels
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven
Country [31] 0 0
Belgium
State/province [31] 0 0
Turnhout
Country [32] 0 0
Belgium
State/province [32] 0 0
Yvoir-Godinne
Country [33] 0 0
Canada
State/province [33] 0 0
Calgary
Country [34] 0 0
Canada
State/province [34] 0 0
Halifax
Country [35] 0 0
Canada
State/province [35] 0 0
St. John's
Country [36] 0 0
Canada
State/province [36] 0 0
Toronto
Country [37] 0 0
Czechia
State/province [37] 0 0
Olomouc
Country [38] 0 0
Czechia
State/province [38] 0 0
Ostrava
Country [39] 0 0
Finland
State/province [39] 0 0
Helsinki
Country [40] 0 0
Finland
State/province [40] 0 0
Oulu
Country [41] 0 0
France
State/province [41] 0 0
Amiens Cedex 1
Country [42] 0 0
France
State/province [42] 0 0
Creteil
Country [43] 0 0
France
State/province [43] 0 0
La Tronche
Country [44] 0 0
France
State/province [44] 0 0
Marseille
Country [45] 0 0
France
State/province [45] 0 0
Montpellier
Country [46] 0 0
France
State/province [46] 0 0
Nantes
Country [47] 0 0
France
State/province [47] 0 0
Nice
Country [48] 0 0
France
State/province [48] 0 0
Paris
Country [49] 0 0
France
State/province [49] 0 0
Pessac Cedex
Country [50] 0 0
France
State/province [50] 0 0
Pierre Benite
Country [51] 0 0
France
State/province [51] 0 0
Poitiers
Country [52] 0 0
France
State/province [52] 0 0
Rennes Cedex 9
Country [53] 0 0
Germany
State/province [53] 0 0
Braunschweig
Country [54] 0 0
Germany
State/province [54] 0 0
Dresden
Country [55] 0 0
Germany
State/province [55] 0 0
Duesseldorf
Country [56] 0 0
Germany
State/province [56] 0 0
Essen
Country [57] 0 0
Germany
State/province [57] 0 0
Leipzig
Country [58] 0 0
Germany
State/province [58] 0 0
Stuttgart
Country [59] 0 0
Hong Kong
State/province [59] 0 0
Hong Kong
Country [60] 0 0
Hungary
State/province [60] 0 0
Budapest
Country [61] 0 0
Hungary
State/province [61] 0 0
Debrecen
Country [62] 0 0
Hungary
State/province [62] 0 0
Gyor
Country [63] 0 0
Hungary
State/province [63] 0 0
Kaposvar
Country [64] 0 0
Hungary
State/province [64] 0 0
Kecskemet
Country [65] 0 0
Hungary
State/province [65] 0 0
Nyiregyhaza
Country [66] 0 0
Hungary
State/province [66] 0 0
Pecs
Country [67] 0 0
Hungary
State/province [67] 0 0
Tatabanya
Country [68] 0 0
Italy
State/province [68] 0 0
Alessandria
Country [69] 0 0
Italy
State/province [69] 0 0
Brescia
Country [70] 0 0
Italy
State/province [70] 0 0
Firenze
Country [71] 0 0
Italy
State/province [71] 0 0
Milan
Country [72] 0 0
Italy
State/province [72] 0 0
Monza
Country [73] 0 0
Italy
State/province [73] 0 0
Novara
Country [74] 0 0
Italy
State/province [74] 0 0
Pesaro
Country [75] 0 0
Italy
State/province [75] 0 0
Terni
Country [76] 0 0
Italy
State/province [76] 0 0
Varese
Country [77] 0 0
Netherlands
State/province [77] 0 0
Groningen
Country [78] 0 0
Netherlands
State/province [78] 0 0
Leeuwarden
Country [79] 0 0
New Zealand
State/province [79] 0 0
Christchurch
Country [80] 0 0
New Zealand
State/province [80] 0 0
Dunedin
Country [81] 0 0
New Zealand
State/province [81] 0 0
Grafton
Country [82] 0 0
New Zealand
State/province [82] 0 0
Hamilton
Country [83] 0 0
New Zealand
State/province [83] 0 0
Palmerston North
Country [84] 0 0
Norway
State/province [84] 0 0
Bergen
Country [85] 0 0
Norway
State/province [85] 0 0
Loerenskog
Country [86] 0 0
Norway
State/province [86] 0 0
Oslo
Country [87] 0 0
Norway
State/province [87] 0 0
Stavanger
Country [88] 0 0
Poland
State/province [88] 0 0
Krakow
Country [89] 0 0
Poland
State/province [89] 0 0
Lublin
Country [90] 0 0
Poland
State/province [90] 0 0
Wroclaw
Country [91] 0 0
Portugal
State/province [91] 0 0
Braga
Country [92] 0 0
Portugal
State/province [92] 0 0
Lisbon
Country [93] 0 0
Portugal
State/province [93] 0 0
Porto
Country [94] 0 0
Spain
State/province [94] 0 0
A Coruña
Country [95] 0 0
Spain
State/province [95] 0 0
Alava
Country [96] 0 0
Spain
State/province [96] 0 0
Barcelona
Country [97] 0 0
Spain
State/province [97] 0 0
Girona
Country [98] 0 0
Spain
State/province [98] 0 0
L´Hospitalet de Llobregat
Country [99] 0 0
Spain
State/province [99] 0 0
Madrid
Country [100] 0 0
Spain
State/province [100] 0 0
Malaga
Country [101] 0 0
Spain
State/province [101] 0 0
Pamplona
Country [102] 0 0
Spain
State/province [102] 0 0
Salamanca
Country [103] 0 0
Spain
State/province [103] 0 0
Sevilla
Country [104] 0 0
Spain
State/province [104] 0 0
Valencia
Country [105] 0 0
Switzerland
State/province [105] 0 0
Bellinzona
Country [106] 0 0
Switzerland
State/province [106] 0 0
Bern
Country [107] 0 0
Switzerland
State/province [107] 0 0
Zurich
Country [108] 0 0
Turkey
State/province [108] 0 0
Ankara
Country [109] 0 0
Turkey
State/province [109] 0 0
Inciralt
Country [110] 0 0
Turkey
State/province [110] 0 0
Mersin
Country [111] 0 0
Turkey
State/province [111] 0 0
Tekirdag
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Birmingham
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Boston
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Canterbury
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

Results publications and other study-related documents

No documents have been uploaded by study researchers.