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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03191799

Registration number

NCT03191799

Ethics application status

Date submitted

15/06/2017

Date registered

19/06/2017

Date last updated

11/06/2021

Titles & IDs

Public title

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

Scientific title

A Single-Arm, Multicenter Phase IIIB Clinical Trial to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

Secondary ID [1]

2016-004366-25

Secondary ID [2]

MO39129

Universal Trial Number (UTN)

Trial acronym

STASEY

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hemophilia A

Condition category

Condition code

Blood

Clotting disorders

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Emicizumab

Experimental: 1.5 mg/kg Emicizumab QW - Participants will receive initial weekly doses of prophylactic emicizumab subcutaneously for 4 weeks, followed by maintenance doses consisting of half the initial dose, administered subcutaneously for the remainder of the 2-year treatment period

Treatment: Drugs: Emicizumab
Initial dosing will be 3 mg/kg/week subcutaneously for 4 weeks; Maintenance dosing will follow at 1.5 mg/kg/week subcutaneously for the remainder of the 2-year treatment period

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Overall Summary of the Number of Participants With Adverse Events, Severity Assessed According to the World Health Organization (WHO) Toxicity Grading Scale

Timepoint [1]

From Baseline until study completion (up to 2 years)

Primary outcome [2]

Adverse Events (AEs) Rates Per 100 Patient-Years for All-Grade AEs, Serious AEs, and Grade =3 AEs

Timepoint [2]

From Baseline until study completion (up to 2 years)

Primary outcome [3]

Number of Participants by Hematology and Biochemistry Laboratory Parameter Test Results as Shifts From the WHO Toxicity Grade at Baseline to the Worst WHO Toxicity Grade Post-Baseline

Timepoint [3]

Baseline, Weeks 2, 3, and 5; Months 3, 6, 9, 12, and 18; and at Early Termination/Study Completion (up to 24 months)

Primary outcome [4]

Change From Baseline in Body Temperature at Specified Timepoints

Timepoint [4]

Baseline, Weeks 2, 3, and 5; Months 3, 6, 9, 12, and 18; and at Early Termination/Study Completion (up to 24 months)

Primary outcome [5]

Change From Baseline in Systolic Blood Pressure at Specified Timepoints

Timepoint [5]

Baseline, Weeks 2, 3, and 5; Months 3, 6, 9, 12, and 18; and at Early Termination/Study Completion (up to 24 months)

Primary outcome [6]

Change From Baseline in Diastolic Blood Pressure at Specified Timepoints

Timepoint [6]

Baseline, Weeks 2, 3, and 5; Months 3, 6, 9, 12, and 18; and at Early Termination/Study Completion (up to 24 months)

Primary outcome [7]

Change From Baseline in Pulse Rate at Specified Timepoints

Timepoint [7]

Baseline, Weeks 2, 3, and 5; Months 3, 6, 9, 12, and 18; and at Early Termination/Study Completion (up to 24 months)

Primary outcome [8]

Change From Baseline in Respiratory Rate at Specified Timepoints

Timepoint [8]

Baseline, Weeks 2, 3, and 5; Months 3, 6, 9, 12, and 18; and at Early Termination/Study Completion (up to 24 months)

Primary outcome [9]

Change From Baseline in Body Weight at Specified Timepoints

Timepoint [9]

Baseline, Weeks 2, 3, and 5; Months 3, 6, 9, 12, and 18; and at Early Termination/Study Completion (up to 24 months)

Secondary outcome [1]

Model-Based Annualized Bleed Rates (ABR) for Treated Bleeds, All Bleeds, Treated Joint Bleeds, Treated Target Joint Bleeds, and Treated Spontaneous Bleeds

Timepoint [1]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [2]

Mean Calculated Annualized Bleed Rates (ABR) for Treated Bleeds, All Bleeds, Treated Joint Bleeds, Treated Target Joint Bleeds, and Treated Spontaneous Bleeds

Timepoint [2]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [3]

Median Calculated Annualized Bleed Rates (ABR) for Treated Bleeds, All Bleeds, Treated Joint Bleeds, Treated Target Joint Bleeds, and Treated Spontaneous Bleeds

Timepoint [3]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [4]

Percentage of Participants by the Categorized Number of Bleeds for Treated Bleeds

Timepoint [4]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [5]

Percentage of Participants by the Categorized Number of Bleeds for All Bleeds

Timepoint [5]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [6]

Percentage of Participants by the Categorized Number of Bleeds for Treated Spontaneous Bleeds

Timepoint [6]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [7]

Percentage of Participants by the Categorized Calculated Annualized Bleed Rates (ABR) for Treated Bleeds

Timepoint [7]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [8]

Percentage of Participants by the Categorized Calculated Annualized Bleed Rates (ABR) for All Bleeds

Timepoint [8]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [9]

Percentage of Participants by the Categorized Calculated Annualized Bleed Rates (ABR) for Treated Spontaneous Bleeds

Timepoint [9]

From first dose of emicizumab until dose up-titration or withdrawal from treatment (median [min-max] efficacy period: 103.14 [1.1-108.3] weeks)

Secondary outcome [10]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Total Score at Specified Timepoints, Adult Participants

Timepoint [10]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [11]

Percentage of Participants With an Improvement From Baseline Greater Than the Responder Threshold for the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Total Score at Specified Timepoints

Timepoint [11]

At 3, 6, 12, and 18 months

Secondary outcome [12]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Physical Health Domain Score at Specified Timepoints, Adult Participants

Timepoint [12]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [13]

Percentage of Participants With an Improvement From Baseline Greater Than the Responder Threshold for the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Physical Health Domain Score at Specified Timepoints

Timepoint [13]

At 3, 6, 12, and 18 months

Secondary outcome [14]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Treatment Domain Score at Specified Timepoints, Adult Participants

Timepoint [14]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [15]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Work and School Domain Score at Specified Timepoints, Adult Participants

Timepoint [15]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [16]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Dealing With Hemophilia Domain Score at Specified Timepoints, Adult Participants

Timepoint [16]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [17]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Feelings Domain Score at Specified Timepoints, Adult Participants

Timepoint [17]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [18]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Family Planning Domain Score at Specified Timepoints, Adult Participants

Timepoint [18]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [19]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Future Domain Score at Specified Timepoints, Adult Participants

Timepoint [19]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [20]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Partnership and Sexuality Domain Score at Specified Timepoints, Adult Participants

Timepoint [20]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [21]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire Sports and Leisure Domain Score at Specified Timepoints, Adult Participants

Timepoint [21]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [22]

Change From Baseline in the Hemophilia Adult Quality of Life (Haem-A-QoL) Questionnaire View of Yourself Domain Score at Specified Timepoints, Adult Participants

Timepoint [22]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [23]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Total Score at Specified Timepoints, Adolescent Participants

Timepoint [23]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [24]

Percentage of Participants With an Improvement From Baseline Greater Than the Responder Threshold for the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Total Score at Specified Timepoints

Timepoint [24]

At 3, 6, 12, and 18 months

Secondary outcome [25]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Physical Health Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [25]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [26]

Timepoint [26]

At 3, 6, 12, and 18 months

Secondary outcome [27]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Treatment Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [27]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [28]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Sports and School Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [28]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [29]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Dealing With Hemophilia Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [29]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [30]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Feelings Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [30]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [31]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Family Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [31]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [32]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Friends Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [32]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [33]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Other People Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [33]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [34]

Change From Baseline in the Hemophilia Quality of Life Short Form (Haemo-QoL-SF) Questionnaire View of Yourself Domain Score at Specified Timepoints, Adolescent Participants

Timepoint [34]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [35]

Change From Baseline in the EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) Index Utility Score at Specified Timepoints

Timepoint [35]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [36]

Change From Baseline in the EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) Quality-of-Life Visual Analogue Scale (VAS) Score at Specified Timepoints

Timepoint [36]

Baseline (Week 1), 3, 6, 12, and 18 months, and at Early Termination or Study Completion (up to 24 months)

Secondary outcome [37]

Percentage of Participants Who Preferred the New Emicizumab Treatment or the Old Hemophilia Treatment, or Without Treatment Preference, as Assessed by the EmiPref Questionnaire

Timepoint [37]

Month 3

Secondary outcome [38]

Number and Percentage of Participants With Anti-Drug Antibodies (ADAs) Against Emicizumab at Anytime Post-Baseline

Timepoint [38]

Baseline (Week 1), Week 5, and at 3, 6, 9, 12, and 18 months, and at early termination/study completion (up to 24 months)

Secondary outcome [39]

Mean Trough Plasma Concentrations of Emicizumab at Specified Timepoints

Timepoint [39]

Pre-dose at Weeks 2, 3, and 5, Months 3, 6, 12, and 18, and at treatment discontinuation (up to 2 years)

Eligibility

Key inclusion criteria

* As per investigator's judgement, a willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the patient-reported outcome (PRO) questionnaires and bleed diaries through the use of an electronic device or paper
* Aged 12 years or older at the time of informed consent
* Diagnosis of congenital hemophilia A with persistent inhibitors against FVIII
* Documented treatment with bypassing agents or FVIII concentrates in the last 6 months (on-demand or prophylaxis). Prophylaxis needs to be discontinued the latest by a day before starting emicizumab
* Adequate hematologic, hepatic, and renal function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method with a failure rate of <1% per year during the treatment period and for at least five elimination half-lives (24 weeks) after the last dose of emicizumab

Minimum age

12 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Inherited or acquired bleeding disorder other than hemophilia A
* Ongoing (or plan to receive during the study) immune tolerance induction (ITI) therapy (prophylaxis regimens with FVIII and/or bypassing agents must be discontinued prior to enrollment). Patients receiving ITI therapy will be eligible following the completion of a 72-hour washout period prior to the first emicizumab administration
* History of illicit drug or alcohol abuse within 12 months prior to screening, as per the investigator's judgment
* High risk for thrombotic microangiopathy (TMA) (e.g., have a previous medical or family history of TMA), as per the investigator's judgment
* Previous (in the past 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or current signs of thromboembolic disease
* Other conditions (e.g., certain autoimmune diseases) that may increase the risk of bleeding or thrombosis
* History of clinically significant hypersensitivity reaction associated with monoclonal antibody therapies or components of the emicizumab injection
* Known human immunodeficiency virus (HIV) infection with CD4 count <200 cells/µL within 6 months prior to screening
* Use of systemic immunomodulators (e.g., interferon or rituximab) at enrollment or planned use during the study, with the exception of antiretroviral therapy
* Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study or that would, in the opinion of the investigator or Sponsor, preclude the patient's safe participation in and completion of the study or interpretation of the study results
* Receipt of: Emicizumab in a prior investigational study; An investigational drug to treat or reduce the risk of hemophilic bleeds within five half-lives of last drug administration; A non-hemophilia-related investigational drug within last 30 days or five half-lives, whichever is shorter; or, Any concurrent investigational drug.
* Pregnancy or lactation, or intent to become pregnant during the study
* Positive serum pregnancy test result within 7 days prior to initiation of emicizumab (females only)

Study design

Purpose of the study

Treatment

Allocation to intervention

Not applicable

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

Single group

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

5/09/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

19/11/2020

Sample size

Target

Accrual to date

Final

195

Recruitment in Australia

Recruitment state(s)

NSW,VIC,WA

Recruitment hospital [1]

Royal Prince Alfred Hospital; Haematology - Camperdown

Recruitment hospital [2]

Alfred Hospital - Melbourne

Recruitment hospital [3]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

3004 - Melbourne

Recruitment postcode(s) [3]

6150 - Murdoch

Recruitment outside Australia

Country [1]

Belgium

State/province [1]

Leuven

Country [2]

Brazil

State/province [2]

Country [3]

Brazil

State/province [3]

Country [4]

Brazil

State/province [4]

Country [5]

Canada

State/province [5]

Alberta

Country [6]

Canada

State/province [6]

Manitoba

Country [7]

Canada

State/province [7]

Ontario

Country [8]

Colombia

State/province [8]

Localidad Puente Aranda

Country [9]

Colombia

State/province [9]

Medellin

Country [10]

Finland

State/province [10]

Helsinki

Country [11]

Germany

State/province [11]

Berlin

Country [12]

Germany

State/province [12]

Bonn

Country [13]

Germany

State/province [13]

Frankfurt/M.

Country [14]

Germany

State/province [14]

Leipzig

Country [15]

Germany

State/province [15]

Mörfelden-Walldorf

Country [16]

Germany

State/province [16]

München

Country [17]

Guatemala

State/province [17]

Guatemala

Country [18]

Hungary

State/province [18]

Budapest

Country [19]

Hungary

State/province [19]

Gyor

Country [20]

Hungary

State/province [20]

Pecs

Country [21]

India

State/province [21]

Karnataka

Country [22]

India

State/province [22]

Maharashtra

Country [23]

India

State/province [23]

WEST Bengal

Country [24]

India

State/province [24]

Pune

Country [25]

Israel

State/province [25]

Tel Hashomer

Country [26]

Italy

State/province [26]

Campania

Country [27]

Italy

State/province [27]

Emilia-Romagna

Country [28]

Italy

State/province [28]

Lazio

Country [29]

Italy

State/province [29]

Lombardia

Country [30]

Italy

State/province [30]

Piemonte

Country [31]

Italy

State/province [31]

Sicilia

Country [32]

Italy

State/province [32]

Toscana

Country [33]

Italy

State/province [33]

Veneto

Country [34]

Mexico

State/province [34]

Mexico CITY (federal District)

Country [35]

Mexico

State/province [35]

Mexico City

Country [36]

Netherlands

State/province [36]

Rotterdam

Country [37]

Netherlands

State/province [37]

Utrecht

Country [38]

Panama

State/province [38]

Panama City

Country [39]

Poland

State/province [39]

Warsaw

Country [40]

Portugal

State/province [40]

Coimbra

Country [41]

Portugal

State/province [41]

Lisboa

Country [42]

Portugal

State/province [42]

Porto

Country [43]

Romania

State/province [43]

Timisoara

Country [44]

Russian Federation

State/province [44]

Altaj

Country [45]

Russian Federation

State/province [45]

Moscow

Country [46]

Russian Federation

State/province [46]

Saint Petersburg

Country [47]

Russian Federation

State/province [47]

Samara

Country [48]

Saudi Arabia

State/province [48]

Riyadh

Country [49]

Spain

State/province [49]

Barcelona

Country [50]

Spain

State/province [50]

Madrid

Country [51]

Spain

State/province [51]

Malaga

Country [52]

Spain

State/province [52]

Sevilla

Country [53]

Spain

State/province [53]

Valencia

Country [54]

Sweden

State/province [54]

Göteborg

Country [55]

Sweden

State/province [55]

Solna

Country [56]

Switzerland

State/province [56]

Bern

Country [57]

United Kingdom

State/province [57]

Birmingham

Country [58]

United Kingdom

State/province [58]

London

Country [59]

United Kingdom

State/province [59]

Newcastle upon Tyne

Country [60]

United Kingdom

State/province [60]

Sheffield

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Hoffmann-La Roche

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

Trial website

https://clinicaltrials.gov/study/NCT03191799

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Clinical Trials

Address

Hoffmann-La Roche

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		https://cdn.clinicaltrials.gov/large-docs/99/NCT03191799/Prot_000.pdf
Statistical analysis plan		https://cdn.clinicaltrials.gov/large-docs/99/NCT03191799/SAP_001.pdf

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03191799

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03191799