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Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations. (ReTHINK)

Primary Purpose

Myelofibrosis With High Molecular Risk Mutations

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ruxolitinib

Ruxolitinib Placebo

About this trial

This is an interventional treatment trial for Myelofibrosis With High Molecular Risk Mutations focused on measuring Early Myelofibrosis, high molecular risk mutations., Ruxolitinib, INC424, High molecular risk mutations, HMR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed diagnosis of MF with bone marrow fibrosis of at least Grade 1; irrespective of JAK2 mutational status
Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2 and IDH1/2)
Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal margin to the point of greatest splenic protrusion
Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3

Exclusion Criteria:

Patients with prior treatment with ruxolitinib or other JAK inhibitors.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ruxolitinib

Ruxolitinib Placebo

Arm Description

Two tablets of ruxolitinib 5 mg were administered orally twice per day.

Two tablets of 5mg placebo were administered orally twice per day.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS-1)

Progression free survival (PFS-1) from date of randomization until the occurrence of any of the criteria for disease progression: Progressive splenomegaly Circulating peripheral blast counts > 10% Leukemic transformation Hb < 10g/dl with absolute decrease of at least 3 g/dl from baseline White blood cell (WBC) counts > 25 x 103/ μL MF-7 score ≥ 30 Death from any cause

Secondary Outcome Measures

Time to Primary Progression (TTP)

TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event.

Percentage Change in Spleen Volume From Baseline

Change in spleen volume (by MRI/CT) from baseline

Percentage Change in Symptoms From Baseline Using MF-7

Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms.

Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D

EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants. The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg "I have no problems walking" to "I am unable to walk"), except for the following overall health check, where 100 is the best of health, and 0 is the worst health.

Overall Survival

To evaluate the effect of ruxolitinib on overall survival

Plasma Ruxolitinib Concentrations

Characterize pharmacokinetics (PK)by utilizing a population PK approach.

Progression Free Survival (PFS-2)

PFS-2 assessed by 25% increase over new baseline of PFS-1 in any of the following: ● Progressive splenomegaly ● 25 % increase in MF-7 score with absolute score ≥ 30

Quality-adjusted Life Years From Baseline

EQ-5D-5L (EuroQol-5D-5L, is a standardized instrument for measuring health outcomes, is consists of a descriptive system and a visual analogue scale - scores can be summarized into a single index score that provides a simple measure of health for clinical and economic appraisal ) The EQ-5D-5L health states will be converted into index values (utilities) from which the QALY (Quality - adjusted life years) will be calculated. QALY will be summarized descriptively by treatment arm.

Time to First Progressive Splenomegaly (TTPS)

Time to first progressive splenomegaly as determined by spleen volume (by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT).

Time to First Symptomatic Progression (TTSP)

Time to first symptomatic progression as determined by Myelofibrosis 7 Item Symptom Scale (MF-7)

Full Information

NCT ID

NCT02598297

First Posted

October 27, 2015

Last Updated

July 8, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02598297

Brief Title

Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.

Acronym

ReTHINK

Official Title

A Randomized, Double Blind, Placebo-controlled, Multicenter, Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Why Stopped

Unresolvable inability to recruit the patients.

Study Start Date

February 3, 2016 (Actual)

Primary Completion Date

October 23, 2017 (Actual)

Study Completion Date

October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelofibrosis With High Molecular Risk Mutations

Keywords

Early Myelofibrosis, high molecular risk mutations., Ruxolitinib, INC424, High molecular risk mutations, HMR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ruxolitinib

Arm Type

Active Comparator

Arm Description

Two tablets of ruxolitinib 5 mg were administered orally twice per day.

Arm Title

Ruxolitinib Placebo

Arm Type

Placebo Comparator

Arm Description

Two tablets of 5mg placebo were administered orally twice per day.

Intervention Type

Drug

Intervention Name(s)

Ruxolitinib

Other Intervention Name(s)

INC424

Intervention Description

5 mg tablet for oral use

Intervention Type

Drug

Intervention Name(s)

Ruxolitinib Placebo

Intervention Description

5 mg placebo tablet for oral use

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS-1)

Description

Time Frame

From randomization till disease progression (estimated to be assessed up 48 months)

Secondary Outcome Measure Information:

Title

Time to Primary Progression (TTP)

Description

TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event.

Time Frame

From randomization till progression (estimated to be assessed up to 48 months)

Title

Percentage Change in Spleen Volume From Baseline

Description

Change in spleen volume (by MRI/CT) from baseline

Time Frame

From baseline and assessed on 12 week intervals until end of treatment (EOT)

Title

Percentage Change in Symptoms From Baseline Using MF-7

Description

Time Frame

From Baseline and assessed every 4 weeks until end of treatment

Title

Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D

Description

Time Frame

From Baseline and assessed every 4 weeks until end of treatment

Title

Overall Survival

Description

To evaluate the effect of ruxolitinib on overall survival

Time Frame

Time from randomization to date of death due to any cause (estimated to be assessed up to 48 months).

Title

Plasma Ruxolitinib Concentrations

Description

Characterize pharmacokinetics (PK)by utilizing a population PK approach.

Time Frame

Week 12, Wk 48

Title

Progression Free Survival (PFS-2)

Description

PFS-2 assessed by 25% increase over new baseline of PFS-1 in any of the following: ● Progressive splenomegaly ● 25 % increase in MF-7 score with absolute score ≥ 30

Time Frame

From date of randomization until second disease progression or death, whichever comes first (estimated to be assessed up to 72 months)

Title

Quality-adjusted Life Years From Baseline

Description

Time Frame

Change from Baseline compared with scheduled study visits at the following intervals every 4 weeks up to week 24, every 8 weeks up to Week 48, every 12 weeks past Wk 48 until End of treatment and 30 day follow up visit

Title

Time to First Progressive Splenomegaly (TTPS)

Description

Time to first progressive splenomegaly as determined by spleen volume (by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT).

Time Frame

From randomization until earliest time to progressive splenomegaly (estimated to be assessed up to 48 months)

Title

Time to First Symptomatic Progression (TTSP)

Description

Time to first symptomatic progression as determined by Myelofibrosis 7 Item Symptom Scale (MF-7)

Time Frame

From randomization until symptomatic progression (MF-7)(estimated to be assessed up to 48 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed diagnosis of MF with bone marrow fibrosis of at least Grade 1; irrespective of JAK2 mutational status Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2 and IDH1/2) Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal margin to the point of greatest splenic protrusion Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3 Exclusion Criteria: Patients with prior treatment with ruxolitinib or other JAK inhibitors.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Concord NSW

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

Novartis Investigative Site

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Novartis Investigative Site

City

Wooloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

08270-070

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

ZIP/Postal Code

01236030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK 9000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Herlev

ZIP/Postal Code

DK 2730

Country

Denmark

Facility Name

Novartis Investigative Site

City

Bayonne

State/Province

Bayonne Cedex

ZIP/Postal Code

64109

Country

France

Facility Name

Novartis Investigative Site

City

Angers Cedex 1

ZIP/Postal Code

49033

Country

France

Facility Name

Novartis Investigative Site

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Novartis Investigative Site

City

Chambéry Cedex

ZIP/Postal Code

73011

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Rouen Cedex 1

ZIP/Postal Code

76038

Country

France

Facility Name

Novartis Investigative Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Novartis Investigative Site

City

Luebeck

State/Province

Schleswig-holstein

ZIP/Postal Code

23563

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle S

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Heilbronn

ZIP/Postal Code

74072

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50671

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

Nordhorn

ZIP/Postal Code

48527

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H 1083

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Zrifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Emilia

State/Province

ZIP/Postal Code

42123

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Terni

State/Province

ZIP/Postal Code

05100

Country

Italy

Facility Name

Novartis Investigative Site

City

Varese

State/Province

ZIP/Postal Code

21100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

453-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Maebashi city

State/Province

Gunma

ZIP/Postal Code

371 8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe-city

State/Province

Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Novartis Investigative Site

City

Isehara

State/Province

Kanagawa

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

Novartis Investigative Site

City

Suita city

State/Province

Osaka

ZIP/Postal Code

565 0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-city

State/Province

Yamanashi

ZIP/Postal Code

409-3898

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

N-5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Loerenskog

ZIP/Postal Code

NO 1478

Country

Norway

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Novartis Investigative Site

City

Torun

ZIP/Postal Code

87 100

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50 367

Country

Poland

Facility Name

Novartis Investigative Site

City

Faro

ZIP/Postal Code

8000-386

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

191024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Novartis Investigative Site

City

Cadiz

State/Province

Andalucia

ZIP/Postal Code

11009

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Huddinge

ZIP/Postal Code

SE-14186

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uddevalla

ZIP/Postal Code

451 80

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St Gallen

ZIP/Postal Code

9001

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Putzu City

State/Province

Chiayi Hsien

ZIP/Postal Code

61363

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06460

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34890

Country

Turkey

Facility Name

Novartis Investigative Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Novartis Investigative Site

City

Talas / Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Novartis Investigative Site

City

Edgbaston

State/Province

Birmingham

ZIP/Postal Code

B15 2GW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Westbruy On Trym

State/Province

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.

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Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations. (ReTHINK)

Myelofibrosis With High Molecular Risk Mutations

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial