NCT02525029

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (Arm 1) or refractory/dependent (Arm 2) aGVHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 14, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

5.2 years

First QC Date

July 14, 2015

Results QC Date

April 10, 2023

Last Update Submit

December 12, 2023

Conditions

Graft vs Host Disease

Keywords

GVHD

Outcome Measures

Primary Outcomes (6)

  • Phase I: MTD (USP hCG)

    Maximum tolerated dose (MTD) of Pregnyl® when given with standard immunosuppressive therapy in pediatric and adult patients with high-risk or refractory acute graft-versus-host disease (aGVHD). Dosage measured as (USP hCG/pg EGF/mm\^2).

    Day 14 after initiation of protocol therapy

  • Phase I: MTD (pg EGF/m^2)

    Maximum tolerated dose (MTD) of Pregnyl® when given with standard immunosuppressive therapy in pediatric and adult patients with high-risk or refractory acute graft-versus-host disease (aGVHD). Dosage measured as (USP hCG/pg EGF/m\^2).

    Day 14 after initiation of protocol therapy

  • Number of Patients With Complete Response

    Percentage of complete response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. Complete response is defined as a Stage of 0 for all organs with no additional intervening therapy for their GVHD.

    Day 28 after initiation of protocol therapy

  • Number of Patients With Partial Response

    Percentage of partial response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. Partial response is defined as improvement by at least 1 stage in all involved organs without progression in others with no additional intervening therapy for their GVHD.

    Day 28 after initiation of protocol therapy

  • Number of Patients With Mixed Response

    Percentage of mixed response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. Mixed Response is defined as improvement in one organ with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ.

    Day 28 after initiation of protocol therapy

  • Number of Patients With No Response

    Percentage of no response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. No response is defined as deterioration of any organ involved.

    Day 28 after initiation of protocol therapy

Secondary Outcomes (5)

  • Number of Participants With Adverse Events as a Measure of Safety and Feasibility of hCG Supplementation With Pregnyl®

    Day 70 after initiation of protocol therapy

  • Number of Participants With Incidence of aGVHD Flare

    Day 28 after initiation of protocol therapy

  • Number of Participants With Incidence of aGVHD Flare

    Day 56 after initiation of protocol therapy

  • Rate of Participants Who Fail Treatment at Day 28

    Day 28 after initiation of protocol therapy

  • Rate of Participants Who Fail Treatment at Day 56

    Day 56 after initiation of protocol therapy

Study Arms (20)

Arm 1: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 1: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2A: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2A: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2A: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2B: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2B: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^2

EXPERIMENTAL

Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

Drug: Pregnyl®

Arm 1: Phase 2 MTD

EXPERIMENTAL

After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low

Drug: Pregnyl®

Arm 2A: MTD

EXPERIMENTAL

After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low

Drug: Pregnyl®

Arm 2B: MTD

EXPERIMENTAL

After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low

Drug: Pregnyl®

Interventions

Pregnyl®DRUG

Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.

Also known as: Human chorionic gonadotropin (hCG)
Arm 1: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2Arm 1: Phase 2 MTDArm 1: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2Arm 2A: MTDArm 2A: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2Arm 2A: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2Arm 2A: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2Arm 2B: MTDArm 2B: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^2Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^2Arm 2B: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2

Eligibility Criteria

AgeUp to 76 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Acute graft versus host disease (GVHD) fitting one of the following categories:
  • High-Risk aGVHD (ARM 1): Pediatric or adult (ages 12-76 years) HCT recipients with high-risk acute GVHD, as determined by the refined MN acute GVHD risk score: http://z.umn.edu/MNAcuteGVHDRiskScore OR high risk on the basis of blood biomarkers (Ann Arbor Score 3 or amphiregulin ≥ 33 pg/ml) or
  • Steroid-Refractory aGVHD (ARM 2): Pediatric or adult (ages 12-76 years) HCT recipient with grade II-IV steroid refractory or steroid-dependent acute GVHD, defined as any one of the following:
  • No response of acute GVHD after at least 4 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent
  • Progression of acute GVHD within 3 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent
  • Failure to improve to at least grade II acute GVHD after 14 days of systemic corticosteroids, with initial doses of at least 2 mg/kg prednisone or equivalent
  • Flare of acute GVHD of at least grade II/IV severity despite tapering dose of steroids being \> 0.5 mg/kg/day.
  • Adequate organ function at study enrollment defined as:
  • Renal: 1.73m2Serum creatinine ≤2.5x upper limit of normal (ULN)
  • Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35%
  • Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)

You may not qualify if:

  • Progressive malignancy
  • Diagnosis of a hormone responsive malignancy
  • Uncontrolled infection at initiation of protocol treatment
  • Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible
  • Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
  • Pregnancy as assessed on baseline blood hCG level
  • Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations)
  • Women or men of childbearing potential unwilling to take adequate precautions to avoid pregnancy from the start of protocol treatment through 28 days after the last treatment
  • Pediatric or adult (ages 0-76 years) HCT recipients
  • Suspected high risk GVHD
  • Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

  • Holtan SG, Hoeschen A, Cao Q, Ustun C, Betts BC, Jurdi NE, Maakaron J, Rashidi A, Miller JS, Wagner JE, Blazar BR, Jacobson PA, Panoskaltsis-Mortari A, Weisdorf DJ, MacMillan ML. Phase II, Open-Label Clinical Trial of Urinary-Derived Human Chorionic Gonadotropin/Epidermal Growth Factor for Life-Threatening Acute Graft-versus-Host Disease. Transplant Cell Ther. 2023 Aug;29(8):509.e1-509.e8. doi: 10.1016/j.jtct.2023.05.021. Epub 2023 Jun 4.

    PMID: 37279855DERIVED

  • Holtan SG, Hoeschen AL, Cao Q, Arora M, Bachanova V, Brunstein CG, Miller JS, Rashidi A, Slungaard A, Ustun C, Vercellotti GM, Warlick ED, Betts BC, El Jurdi N, He F, Chen C, Gandhi I, Wagner JE, Blazar BR, Jacobson PA, Shabaneh A, Wang J, Panoskaltsis-Mortari A, MacMillan ML, Weisdorf DJ. Facilitating resolution of life-threatening acute GVHD with human chorionic gonadotropin and epidermal growth factor. Blood Adv. 2020 Apr 14;4(7):1284-1295. doi: 10.1182/bloodadvances.2019001259.

    PMID: 32236525DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Results Point of Contact

Title
Dr. Shernan Holtan, MD
Organization
University of Minnesota, Masonic Cancer Center
sgholtan@umn.edu
(612) 626-5654

Study Officials

  • Shernan Holtan, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

August 17, 2015

Study Start

March 1, 2016

Primary Completion

May 1, 2021

Study Completion

April 1, 2022

Last Updated

December 14, 2023

Results First Posted

December 14, 2023

Record last verified: 2023-12

Locations

US(1)