Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03277105




Registration number
NCT03277105
Ethics application status
Date submitted
7/09/2017
Date registered
8/09/2017
Date last updated
29/04/2025

Titles & IDs
Public title
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2017-000206-38
Secondary ID [2] 0 0
CR108342
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dara SC
Treatment: Drugs - Dara IV

Experimental: Dara SC - Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.

Active comparator: Dara IV - Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.


Treatment: Drugs: Dara SC
Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.

Treatment: Drugs: Dara IV
Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Assessment method [1] 0 0
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required.
Timepoint [1] 0 0
Up to 1 year 8 months
Primary outcome [2] 0 0
Maximum Trough Concentration (Ctrough) of Daratumumab
Assessment method [2] 0 0
Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
Timepoint [2] 0 0
Predose on Cycle 3 Day 1 (each cycle of 28 days)
Secondary outcome [1] 0 0
Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
Assessment method [1] 0 0
Percentage of participants with treatment-emergent infusion-related reactions were reported.
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Assessment method [2] 0 0
PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be \>=0.5 gram per deciliter (g/dL), Urine M-component (absolute increase must be \>=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be \>10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be \>=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Percentage of Participants With Very Good Partial Response (VGPR) or Better
Assessment method [3] 0 0
VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response \[sCR\]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or \>=90 percent (%) reduction in serum M-protein plus urine M-protein \<100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Percentage of Participants With Complete Response (Including sCR) or Better
Assessment method [4] 0 0
CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response \[sCR\]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Time to Next Therapy
Assessment method [5] 0 0
Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Overall Survival (OS)
Assessment method [6] 0 0
OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
Assessment method [7] 0 0
Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.
Timepoint [7] 0 0
Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)
Secondary outcome [8] 0 0
Duration of Response
Assessment method [8] 0 0
Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be \>= 0.5 g/dL and \>=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \> 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Time to Partial Response (PR) or Better
Assessment method [9] 0 0
Time to PR or better was defined as the time from randomization until onset of first response of PR or better.
Timepoint [9] 0 0
Up to 3 years
Secondary outcome [10] 0 0
Time to Very Good Partial Response (VGPR) or Better
Assessment method [10] 0 0
Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.
Timepoint [10] 0 0
Up to 3 years
Secondary outcome [11] 0 0
Time to Complete Response (CR) or Better
Assessment method [11] 0 0
Time to CR or better was defined as the time from randomization until onset of first CR or better.
Timepoint [11] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
* Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
* Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy
* Documented multiple myeloma as defined by the criteria below:

1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria
2. Measurable disease at Screening as defined by any of the following:

1. Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
2. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Meet the clinical laboratory criteria as specified in the protocol
* Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received daratumumab or other anti-CD38 therapies previously
* Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
* Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
* Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
* History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
27/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2024
Sample size
Target
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment postcode(s) [7] 0 0
5011 - Woodville South
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Brazil
State/province [3] 0 0
Barretos
Country [4] 0 0
Brazil
State/province [4] 0 0
Florianopolis
Country [5] 0 0
Brazil
State/province [5] 0 0
Jau
Country [6] 0 0
Brazil
State/province [6] 0 0
Joinville
Country [7] 0 0
Brazil
State/province [7] 0 0
Passo Fundo
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio de Janeiro
Country [10] 0 0
Brazil
State/province [10] 0 0
Salvador
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Jose do Rio Preto
Country [12] 0 0
Brazil
State/province [12] 0 0
São Paulo
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
Czechia
State/province [19] 0 0
Hradec Kralove
Country [20] 0 0
Czechia
State/province [20] 0 0
Olomouc
Country [21] 0 0
Czechia
State/province [21] 0 0
Ostrava
Country [22] 0 0
Czechia
State/province [22] 0 0
Plzen
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 10
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 2
Country [25] 0 0
France
State/province [25] 0 0
Caen
Country [26] 0 0
France
State/province [26] 0 0
Lille Cedex
Country [27] 0 0
France
State/province [27] 0 0
Nantes Cedex 1
Country [28] 0 0
France
State/province [28] 0 0
Pessac
Country [29] 0 0
France
State/province [29] 0 0
Pierre-Bénite
Country [30] 0 0
France
State/province [30] 0 0
Poitiers
Country [31] 0 0
France
State/province [31] 0 0
Vandoeuvre Les Nancy
Country [32] 0 0
Greece
State/province [32] 0 0
Athens Attica
Country [33] 0 0
Israel
State/province [33] 0 0
Hadera
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Israel
State/province [36] 0 0
Petah Tikva
Country [37] 0 0
Israel
State/province [37] 0 0
Ramat Gan
Country [38] 0 0
Israel
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Tel Aviv
Country [39] 0 0
Italy
State/province [39] 0 0
Bologna
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Palermo
Country [42] 0 0
Italy
State/province [42] 0 0
Pavia
Country [43] 0 0
Italy
State/province [43] 0 0
Piacenza
Country [44] 0 0
Italy
State/province [44] 0 0
Roma
Country [45] 0 0
Italy
State/province [45] 0 0
Torino
Country [46] 0 0
Japan
State/province [46] 0 0
Fukuoka
Country [47] 0 0
Japan
State/province [47] 0 0
Fukuyama
Country [48] 0 0
Japan
State/province [48] 0 0
Gifu
Country [49] 0 0
Japan
State/province [49] 0 0
Gunma
Country [50] 0 0
Japan
State/province [50] 0 0
Iwate
Country [51] 0 0
Japan
State/province [51] 0 0
Kobe City
Country [52] 0 0
Japan
State/province [52] 0 0
Kyoto
Country [53] 0 0
Japan
State/province [53] 0 0
Matsuyama
Country [54] 0 0
Japan
State/province [54] 0 0
Nagoya
Country [55] 0 0
Japan
State/province [55] 0 0
Niigata
Country [56] 0 0
Japan
State/province [56] 0 0
Okayama
Country [57] 0 0
Japan
State/province [57] 0 0
Osaka
Country [58] 0 0
Japan
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Sendai-City
Country [59] 0 0
Japan
State/province [59] 0 0
Shibukawa
Country [60] 0 0
Japan
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Shibuya
Country [61] 0 0
Korea, Republic of
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Busan
Country [62] 0 0
Korea, Republic of
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Goyang-Si
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Incheon
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Ulsan
Country [66] 0 0
Poland
State/province [66] 0 0
Brzozow
Country [67] 0 0
Poland
State/province [67] 0 0
Bydgoszcz
Country [68] 0 0
Poland
State/province [68] 0 0
Chorzow
Country [69] 0 0
Poland
State/province [69] 0 0
Gdynia
Country [70] 0 0
Poland
State/province [70] 0 0
Krakow
Country [71] 0 0
Poland
State/province [71] 0 0
Legnica
Country [72] 0 0
Poland
State/province [72] 0 0
Lublin
Country [73] 0 0
Poland
State/province [73] 0 0
Poznan
Country [74] 0 0
Poland
State/province [74] 0 0
Warszawa
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Dzerzhinsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Ekaterinburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Moscow
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Nizny Novgorod
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Penza
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Ryazan
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Saint-Petersburg
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Samara
Country [83] 0 0
Russian Federation
State/province [83] 0 0
St-Petersburg
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Syktyvkar
Country [85] 0 0
Spain
State/province [85] 0 0
Badalona
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Girona
Country [88] 0 0
Spain
State/province [88] 0 0
Granada
Country [89] 0 0
Spain
State/province [89] 0 0
La Laguna
Country [90] 0 0
Spain
State/province [90] 0 0
Leon
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Pamplona
Country [93] 0 0
Spain
State/province [93] 0 0
Pozuelo de Alarcon
Country [94] 0 0
Spain
State/province [94] 0 0
Salamanca
Country [95] 0 0
Spain
State/province [95] 0 0
Valencia
Country [96] 0 0
Sweden
State/province [96] 0 0
Falun
Country [97] 0 0
Sweden
State/province [97] 0 0
Helsingborg
Country [98] 0 0
Sweden
State/province [98] 0 0
Huddinge
Country [99] 0 0
Sweden
State/province [99] 0 0
Lund
Country [100] 0 0
Sweden
State/province [100] 0 0
Umea
Country [101] 0 0
Sweden
State/province [101] 0 0
Uppsala
Country [102] 0 0
Taiwan
State/province [102] 0 0
Changhua
Country [103] 0 0
Taiwan
State/province [103] 0 0
Taichung City
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taichung
Country [105] 0 0
Taiwan
State/province [105] 0 0
Tainan
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taipei
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taoyuan
Country [108] 0 0
Ukraine
State/province [108] 0 0
Cherkasy
Country [109] 0 0
Ukraine
State/province [109] 0 0
Dnepropetrovsk
Country [110] 0 0
Ukraine
State/province [110] 0 0
Ivano-Frankivsk
Country [111] 0 0
Ukraine
State/province [111] 0 0
Kharkiv
Country [112] 0 0
Ukraine
State/province [112] 0 0
Kiev
Country [113] 0 0
Ukraine
State/province [113] 0 0
Lviv
Country [114] 0 0
Ukraine
State/province [114] 0 0
Mykolaiv
Country [115] 0 0
Ukraine
State/province [115] 0 0
Poltava
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Blackpool
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Bournemouth
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Leicester
Country [119] 0 0
United Kingdom
State/province [119] 0 0
London
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Manchester
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Nottingham
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Surrey
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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

No information has been provided regarding IPD availability


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/NCT03277105