NCT02411708

Brief Summary

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

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

April 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

April 2, 2015

Last Update Submit

May 22, 2018

Conditions

Anemia, Sickle Cell

Outcome Measures

Primary Outcomes (1)

  • Time to readiness for discharge from ambulatory site

    Defined as the time from the start of study drug infusion until the time of participant's response that their pain episode has improved enough for discharge; investigator's assessment of participant's readiness for discharge; and participant no longer requires IV opioid administration

    7 Days

Secondary Outcomes (6)

  • Safety of treatment

    1 Day

  • Extent of reduction in pain score during ambulatory visit as assessed by the participant on a 10-point pain scale

    1 Day

  • Total pain treatment received including the opioid dose (mg/kg) received during ambulatory visit

    1 Day

  • Global assessment of the participant's improvement by the Investigator or study staff (at the time of readiness for discharge from the ambulatory visit, and at the 72-hour follow-up visit)

    7 Days

  • Reduction in the rate of recurrent ambulatory visit(s) for the VOC within 7 days post discharge

    7 Days

  • +1 more secondary outcomes

Study Arms (2)

SANGUINATE

EXPERIMENTAL

320 mg/kg

Drug: SANGUINATE

Placebo

PLACEBO COMPARATOR

Normal saline IV infusion

Drug: Placebo

Interventions

SANGUINATEDRUG

Single two-hour infusion of SANGUINATE

Also known as: pegylated carboxyhemoglobin bovine
SANGUINATE
PlaceboDRUG

Single two-hour infusion of placebo

Also known as: Normal Saline
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years,
  • Sickle Cell Disease (all genotypes),
  • Diagnosis of a severe vaso-occlusive crisis (VOC), based on the clinical judgement of the Investigator,
  • Participant needs to be admitted to the ambulatory site for treatment of VOC requiring IV pain medication,
  • Able to provide written consent,
  • Able to receive IV infusion of study drug.

You may not qualify if:

  • In the judgment of the Investigator, the participant is not a good candidate for the study,
  • An acute severe complication of SCD beyond VOC,
  • Pregnant or actively trying to become pregnant, or breastfeeding,
  • Participant had \> 6 urgent visits for SCD complications in the prior 3 months,
  • Fewer than 30 days since any prior treatment with IV pain medication for VOC,
  • Onset of current acute painful crisis \> 3 days prior to dosing,
  • Evidence of moderate to severe renal insufficiency (CrCl \< 50 mL/min) or chronic kidney disease, or of moderate to severe hepatic disease (LFTs \> 2 x ULN) based on past medical history,
  • Concurrent or prior treatment within 90 days with an investigational medication,
  • Abnormal ECG due to cardiac ischemia and/or atrial fibrillation of acute onset, in the opinion of the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

FSCDR

Hollywood, Florida, 33021, United States

Location

Florida Health Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1559, United States

Location

Johns Hopkins Univeristy School of Medicine

Baltimore, Maryland, 21205, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University of Rochester Medical Center

Rochester, New York, 14627-0140, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43203, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

PEGylated carboxyhemoglobin bovineSaline Solution

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 8, 2015

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 23, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(9)