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CompletedNCT02605993Updated Jan 4, 2023Results posted

Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

A Phase 2 interventional study of Ravulizumab in Paroxysmal Nocturnal Hemoglobinuria and PNH, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 16 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Alexion Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of multiple intravenous (IV) doses of ravulizumab administered to complement inhibitor treatment-naïve participants with PNH.

Read the detailed description

The study consisted of a screening period of up to 30 days and a Treatment Period of up to 253 days for Cohorts 1-3 and 281 days for Cohort 4. After completion of the Treatment Period, all participants had the opportunity to enter the Extension Period, wherein participants continue to receive ravulizumab for up to 5 years. The first dose in the Extension Period occurred on Day 253 for Cohorts 1-3 and on Day 281 for Cohort 4.

The data presented includes the Primary Completion date of the study for the Treatment Period. The results for the Extension Period will be reported after study completion.

02

Conditions studied

  • Paroxysmal Nocturnal Hemoglobinuria
  • PNH

Keywords

  • complement inhibitor
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female ≥18 years of age
  2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry
  3. Documented meningococcal vaccination not more than 3 years prior to dosing
  4. Female participants of childbearing potential were to use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
  5. Willing and able to give written informed consent and comply with the study visit schedule

Exclusion criteria

Exclusion Criteria:

  1. Treatment with a complement inhibitor at any time
  2. Female participants who are planning to become pregnant, or are pregnant, breastfeeding or who had a positive pregnancy test at screening or Day 1
  3. Participation in an interventional clinical study within 30 days before initiation of dosing on Day 1, or use of any experimental therapy within 30 days prior to dosing on Day 1, or within 5 half-lives of the investigational product, whichever was greater
  4. History of allergy to any drug, allergen, excipients of ravulizumab or known allergy to Chinese hamster ovary cell proteins
  5. Inability to comply with study requirements
  6. History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or rheumatoid disease that, in the Investigator's judgment, would preclude participation
  7. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrollment
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Cohort 1

    During the Treatment Period, participants were administered ravulizumab 1400 milligram (mg) on Day 1, ravulizumab 1000 mg on Day 15 and Day 29, and then ravulizumab 1000 mg every 4 weeks for 7 doses. In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kilograms (kg), 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more.

    Biological: Ravulizumab

  • Experimental
    Cohort 2

    During the Treatment Period, participants were administered ravulizumab 2000 mg on Day 1, ravulizumab 1600 mg on Day 22 and Day 43, and then ravulizumab 1600 mg every 6 weeks for 4 doses. In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more.

    Biological: Ravulizumab

  • Experimental
    Cohort 3

    During the Treatment Period, participants were administered ravulizumab 1600 mg on Day 1 and Day 15, ravulizumab 2400 mg on Day 29, and then ravulizumab 2400 mg every 8 weeks for 3 doses. In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more.

    Biological: Ravulizumab

  • Experimental
    Cohort 4

    During the Treatment Period, participants were administered ravulizumab 3000 mg on Day 1, ravulizumab 5400 mg on Day 29, and then ravulizumab 5400 mg every 12 weeks for 2 doses. During the Extension Period, participants were administered ravulizumab 5400 mg every 12 weeks for up to 5 years.

    Biological: Ravulizumab

Interventions

  • BiologicalRavulizumab

    All treatments were given as IV infusions.

    Also known as: ALXN1210, Ultomiris

05

What researchers measure

Primary outcomes

  1. Percent Change In LDH Levels From Baseline To Day 253 And Day 281

    The percent change in LDH levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

    Time frame: Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)

Secondary outcomes

  1. Percent Change In Free Hemoglobin Levels From Baseline To Day 253 And Day 281

    The percent change in free hemoglobin levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

    Time frame: Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)

  2. Percent Change In Haptoglobin Levels From Baseline To Day 253 And Day 281

    The percent change in haptoglobin levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

    Time frame: Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)

  3. Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 253 And Day 281

    The percent change in reticulocyte/erythrocyte count levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

    Time frame: Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)

  4. Percent Change In PNH RBC Types II And III Clone Size From Baseline To Day 253

    The percent change in paroxysmal nocturnal hemoglobinuria (PNH) red blood cell (RBC), summed types II and III, clone size levels were assessed from Baseline to Day 253 for Cohorts 1 to 4.

    Time frame: Baseline, Day 253 (Cohorts 1 to 4)

  5. Percent Change In D-dimer From Baseline To Day 253 And Day 281

    The percent change in D-dimer levels were assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

    Time frame: Baseline to Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)

  6. Change In Clinical Manifestations Of PNH From Baseline To Day 253 And Day 281

    Clinical manifestations were assessed from Baseline to Day 253 for Cohorts 1 to 3 and from Baseline to Day 281 for Cohort 4 only. Clinical manifestations were defined as fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction (male participants only). Improvement was defined as present at Baseline and absent at Day endpoint. Worsening was defined as absent at Baseline and present at Day endpoint. No Change was defined as no change from Baseline and time point of endpoint.

    Time frame: Baseline, Day 253 (Cohorts 1 to 3) and Day 281 (Cohort 4)

06

Results

Posted Feb 18, 2019

Participant flow

Treatment Period
Participant flow — Treatment Period
MilestoneCohort 1Cohort 2Cohort 3Cohort 4
Started6677
Received at least 1 dose of study drug6677
Completed6677
Not completed0000
Extension Period
Participant flow — Extension Period
MilestoneCohort 1Cohort 2Cohort 3Cohort 4
Started6677
Received at least 1 dose of study drug6677
Completed6667
Not completed0010
Withdrew: Participant underwent bone marrow transplantation due to chronic myelomonocytic leukemia0010

Outcome measures

PrimaryPercent Change In LDH Levels From Baseline To Day 253 And Day 281

The percent change in LDH levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

Time frame:
Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)
Reported as:
Mean · Percent Change
Percent Change In LDH Levels From Baseline To Day 253 And Day 281
Percent ChangeCohort 1Cohort 2Cohort 3Cohort 4
Day 253-72.85 ± 12.082-78.12 ± 6.635-84.96 ± 4.423-87.63 ± 6.923
Day 281———-89.89 ± 2.885
Statistical analysis
  • Cohort 1 vs Cohort 2 vs Cohort 3 vs Cohort 4 · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.)
  • Cohort 4 · MMRM · p = <0.0001 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.)
SecondaryPercent Change In Free Hemoglobin Levels From Baseline To Day 253 And Day 281

The percent change in free hemoglobin levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

Time frame:
Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)
Reported as:
Mean · Percent Change
Percent Change In Free Hemoglobin Levels From Baseline To Day 253 And Day 281
Percent ChangeCohort 1Cohort 2Cohort 3Cohort 4
Day 25314.07 ± 124.755-12.32 ± 57.213-22.14 ± 94.388-40.80 ± 27.474
Day 281———-45.64 ± 28.938
Statistical analysis
  • Cohort 1 vs Cohort 2 vs Cohort 3 vs Cohort 4 · MMRM · p = 0.0214 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.)
  • Cohort 4 · MMRM · p = 0.0313 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.)
SecondaryPercent Change In Haptoglobin Levels From Baseline To Day 253 And Day 281

The percent change in haptoglobin levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

Time frame:
Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)
Reported as:
Mean · Percent Change
Percent Change In Haptoglobin Levels From Baseline To Day 253 And Day 281
Percent ChangeCohort 1Cohort 2Cohort 3Cohort 4
Day 25321.67 ± 53.07281.67 ± 200.0424.29 ± 11.33934.29 ± 74.578
Day 281———27.14 ± 56.188
Statistical analysis
  • Cohort 1 vs Cohort 2 vs Cohort 3 vs Cohort 4 · MMRM · p = 0.0625 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.)
  • Cohort 4 · MMRM · p = 0.5000 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.)
SecondaryPercent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 253 And Day 281

The percent change in reticulocyte/erythrocyte count levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

Time frame:
Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)
Reported as:
Mean · Percent Change
Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 253 And Day 281
Percent ChangeCohort 1Cohort 2Cohort 3Cohort 4
Day 253-1.27 ± 43.019-5.05 ± 35.69110.46 ± 59.51014.66 ± 81.390
Day 281———-4.66 ± 68.502
Statistical analysis
  • Cohort 1 vs Cohort 2 vs Cohort 3 vs Cohort 4 · MMRM · p = 0.4871 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.)
  • Cohort 4 · MMRM · p = 0.4688 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.)
SecondaryPercent Change In PNH RBC Types II And III Clone Size From Baseline To Day 253

The percent change in paroxysmal nocturnal hemoglobinuria (PNH) red blood cell (RBC), summed types II and III, clone size levels were assessed from Baseline to Day 253 for Cohorts 1 to 4.

Time frame:
Baseline, Day 253 (Cohorts 1 to 4)
Reported as:
Mean · Percent Change
Percent Change In PNH RBC Types II And III Clone Size From Baseline To Day 253
Percent ChangeCohort 1Cohort 2Cohort 3Cohort 4
Percent Change In PNH RBC Types II And III Clone Size From Baseline To Day 2536.65 ± 24.1015.47 ± 21.94054.14 ± 98.71388.21 ± 138.290
Statistical analysis
  • Cohort 1 vs Cohort 2 vs Cohort 3 vs Cohort 4 · MMRM · p = 0.0023 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.)
SecondaryPercent Change In D-dimer From Baseline To Day 253 And Day 281

The percent change in D-dimer levels were assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.

Time frame:
Baseline to Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)
Reported as:
Mean · Percent Change
Percent Change In D-dimer From Baseline To Day 253 And Day 281
Percent ChangeCohort 1Cohort 2Cohort 3Cohort 4
Day 253-24.80 ± 32.436-29.47 ± 26.547-10.90 ± 41.032-16.08 ± 34.783
Day 281———-27.05 ± 27.663
Statistical analysis
  • Cohort 1 vs Cohort 2 vs Cohort 3 vs Cohort 4 · MMRM · p = 0.0029 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.)
  • Cohort 4 · MMRM · p = 0.1250 (Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.)
SecondaryChange In Clinical Manifestations Of PNH From Baseline To Day 253 And Day 281

Clinical manifestations were assessed from Baseline to Day 253 for Cohorts 1 to 3 and from Baseline to Day 281 for Cohort 4 only. Clinical manifestations were defined as fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction (male participants only). Improvement was defined as present at Baseline and absent at Day endpoint. Worsening was defined as absent at Baseline and present at Day endpoint. No Change was defined as no change from Baseline and time point of endpoint.

Time frame:
Baseline, Day 253 (Cohorts 1 to 3) and Day 281 (Cohort 4)
Reported as:
Count of participants · Participants
Change In Clinical Manifestations Of PNH From Baseline To Day 253 And Day 281
ParticipantsCohort 1Cohort 2Cohort 3Cohort 4
Fatigue at Day 253 — Improved from Baseline4233
Fatigue at Day 253 — Worsened from Baseline0000
Fatigue at Day 253 — No Change2444
Fatigue at Day 253 — Not Applicable0000
Fatigue at Day 281 — Improved from Baseline———4
Fatigue at Day 281 — Worsened from Baseline———0
Fatigue at Day 281 — No Change———3
Fatigue at Day 281 — Not Applicable———0
Abdominal Pain at Day 253 — Improved from Baseline1110
Abdominal Pain at Day 253 — Worsened from Baseline0000
Abdominal Pain at Day 253 — No Change5567
Abdominal Pain at Day 253 — Not Applicable0000
Abdominal Pain at Day 281 — Improved from Baseline———0
Abdominal Pain at Day 281 — Worsened from Baseline———0
Abdominal Pain at Day 281 — No Change———7
Abdominal Pain at Day 281 — Not Applicable———0
Dyspnea at Day 253 — Improved from Baseline1142
Dyspnea at Day 253 — Worsened from Baseline0000
Dyspnea at Day 253 — No Change5535
Dyspnea at Day 253 — Not Applicable0000
Dyspnea at Day 281 — Improved from Baseline———2
Dyspnea at Day 281 — Worsened from Baseline———0
Dyspnea at Day 281 — No Change———5
Dyspnea at Day 281 — Not Applicable———0
Dysphagia at Day 253 — Improved from Baseline0111
Dysphagia at Day 253 — Worsened from Baseline0000
Dysphagia at Day 253 — No Change6566
Dysphagia at Day 253 — Not Applicable0000
Dysphagia at Day 281 — Improved from Baseline———1
Dysphagia at Day 281 — Worsened from Baseline———0
Dysphagia at Day 281 — No Change———6
Dysphagia at Day 281 — Not Applicable———0
Chest Pain at Day 253 — Improved from Baseline1020
Chest Pain at Day 253 — Worsened from Baseline0000
Chest Pain at Day 253 — No Change5657
Chest Pain at Day 253 — Not Applicable0000
Chest Pain at Day 281 — Improved from Baseline———0
Chest Pain at Day 281 — Worsened from Baseline———0
Chest Pain at Day 281 — No Change———7
Chest Pain at Day 281 — Not Applicable———0
Erectile Dysfunction at Day 253 — Improved from Baseline2011
Erectile Dysfunction at Day 253 — Worsened from Baseline0000
Erectile Dysfunction at Day 253 — No Change2554
Erectile Dysfunction at Day 253 — Not Applicable2112
Erectile Dysfunction at Day 281 — Improved from Baseline———1
Erectile Dysfunction at Day 281 — Worsened from Baseline———0
Erectile Dysfunction at Day 281 — No Change———4
Erectile Dysfunction at Day 281 — Not Applicable———2

Adverse events

Collected over Adverse events were monitored continuously from Screening to Day 253 (for Cohorts 1, 2, and 3) and Day 281 (for Cohort 4) (Treatment Period) and up to Day 2157 (Extension Period).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 10/6 (0%)3/6 (50%)6/6 (100%)
Cohort 20/6 (0%)3/6 (50%)6/6 (100%)
Cohort 30/7 (0%)4/7 (57.1%)7/7 (100%)
Cohort 40/7 (0%)1/7 (14.3%)7/7 (100%)
Most frequent serious events
Showing 10 of 38
Most frequent serious events
EventCohort 1Cohort 2Cohort 3Cohort 4
Febrile neutropeniaBlood and lymphatic system disorders1/61/60/70/7
PyrexiaGeneral disorders1/60/60/70/7
Meningococcal infectionInfections and infestations0/61/60/70/7
Urinary tract infectionInfections and infestations0/61/60/70/7
Femoral neck fractureInjury, poisoning and procedural complications0/61/60/70/7
InfectionInfections and infestations0/61/60/70/7
Klebsiella bacteraemiaInfections and infestations0/61/60/70/7
Enterobacter bacteraemiaInfections and infestations0/61/60/70/7
Enterobacter sepsisInfections and infestations0/61/60/70/7
Escherichia urinary tract infectionInfections and infestations0/61/60/70/7
Most frequent other events
Showing 10 of 66
Most frequent other events
EventCohort 1Cohort 2Cohort 3Cohort 4
HeadacheNervous system disorders3/65/64/73/7
Upper respiratory tract infectionInfections and infestations2/61/65/74/7
NasopharyngitisInfections and infestations4/62/63/72/7
Back painMusculoskeletal and connective tissue disorders4/60/62/71/7
FatigueGeneral disorders3/62/60/70/7
ArthralgiaMusculoskeletal and connective tissue disorders3/60/60/72/7
DyspnoeaRespiratory, thoracic and mediastinal disorders3/60/60/71/7
Abdominal painGastrointestinal disorders3/60/61/72/7
DizzinessNervous system disorders1/60/63/70/7
DiarrhoeaGastrointestinal disorders0/61/63/70/7

Baseline characteristics

Safety set: All participants who received at least 1 dose of ravulizumab.

Age, Continuous
Age, Continuous(years)Cohort 1Cohort 2Cohort 3Cohort 4Total
Mean43.1 ± 14.5748.6 ± 23.4837.3 ± 14.0348.5 ± 13.4344.3 ± 16.33
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Total
Female21126
Male456520
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Total
Hispanic or Latino10001
Not Hispanic or Latino447722
Unknown or Not Reported12003
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Total
White543315
Asian00437
Not Reported12003
Other00011
Lactate Dehydrogenase (LDH) Levels
Lactate Dehydrogenase (LDH) Levels(units/liter (U/L))Cohort 1Cohort 2Cohort 3Cohort 4Total
Mean1026.88 ± 547.8431223.55 ± 149.6932127.57 ± 815.8752142.24 ± 366.5111668.90 ± 724.341
07

Study locations

16 sites
  • Clinical Trial Site
    Toronto, Ontario M4N 3M5, Canada
  • Clinical Trial Site
    Lyon, Pierre-Bénite 69495, France
  • Clinical Trial Site
    Lille, 59037, France
  • Clinical Trial Site
    Paris, 75475, France
  • Clinical Trial Site
    Ulm, Baden Wuerttemberg 89081, Germany
  • Clinical Trial Site
    Aachen, Nordrhein Westfalen 52074, Germany
  • Clinical Trial Site
    Essen, Nordrhein Westfalen 45147, Germany
  • Clinical Trial Site
    Seoul, 03080, Korea, Republic of
  • Clinical Trial Site
    Seoul, 03722, Korea, Republic of
  • Clinical Trial Site
    Badalona, Barcelona 08916, Spain
  • Clinical Trial Site
    Majadahonda, Madrid 28220, Spain
  • Clinical Trial Site
    Barcelona, 08036, Spain
  • Clinical Trial Site
    Madrid, 28040, Spain
  • Clinical Trial Site
    Taipei City, 10048, Taiwan
  • Clinical Trial Site
    Leeds, West Yorkshire LS9 7TF, United Kingdom
  • Clinical Trial Site
    London, SE5 9RS, United Kingdom
08

References and documents

Publications

  • Roth A, Rottinghaus ST, Hill A, Bachman ES, Kim JS, Schrezenmeier H, Terriou L, Urbano-Ispizua A, Wells RA, Jang JH, Kulasekararaj AG, Szer J, Aguzzi R, Damokosh AI, Shafner L, Lee JW. Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies. Blood Adv. 2018 Sep 11;2(17):2176-2185. doi: 10.1182/bloodadvances.2018020644. PubMed 30171081 ↗

Study documents

  • Study protocol · May 9, 2018
  • Statistical analysis plan · Jun 29, 2016

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT02605993
Lead sponsor
Alexion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Nov 17, 2015
Start date
Jan 4, 2016
Primary completion
Feb 23, 2017
Completion
Jan 12, 2022
Results posted
Feb 18, 2019
Last update
Jan 4, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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