Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    GRF6021
Previous Study | Return to List | Next Study

A Study to Evaluate the Effect of GRF6021 on Postoperative Recovery Following Primary Hip or Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03981419
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Alkahest, Inc.

Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE July 12, 2019
Actual Primary Completion Date January 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
Intracellular signaling cascades in blood leukocytes [ Time Frame: Baseline to Day 3 ]
Effect of GRF6021 on intracellular signaling cascades in blood leukocytes as determined by CyTOF.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) [ Time Frame: Baseline to Day 3 ]
    Change from baseline in 3D-CAM. The 3D-CAM is a verbal assessment tool used to test patients for delirium. Each item in the instrument directly informs acute onset of mental status change or fluctuating course of cognition, inattention, disorganized thinking, and altered level of consciousness.
  • Surgery Recovery Scale (SRS) [ Time Frame: Baseline to 6 weeks ]
    Time to 50% recovery of the baseline value in the SRS. The SRS tool assesses functional recovery following major surgery. Impacts on daily activities are scored from 1 to 5 or 6 (1= not at all).
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Pain] [ Time Frame: Baseline to 6 weeks ]
    Time to a score of < 12/40 on a subset of questions from the WOMAC, Pain Subscale. The WOMAC assesses pain, stiffness, and physical function in patients with knee and/or hip osteoarthritis. This is an 11-point scale (0-10). The range for the Pain subscale is 0-40 . The subscales are used independently and not summed. Higher scores = worse (Higher pain score = more pain; higher function score = more impairment)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Function] [ Time Frame: Baseline to 6 weeks ]
    Time to a score of < 18/60 on a subset of questions from the WOMAC, Physical Function Subscale. The WOMAC assesses pain, stiffness, and physical function in patients with knee and/or hip osteoarthritis. This is an 11-point scale (0-10). The range for the Function subscale is 0-60 . The subscales are used independently and not summed. Higher scores = worse (Higher pain score = more pain; higher function score = more impairment)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Total] [ Time Frame: Baseline to 6 weeks ]
    The WOMAC total is a sum of scores from the Pain, Stiffness and Function Subscales. The WOMAC assesses pain, stiffness, and physical function in patients with knee and/or hip osteoarthritis. This is an 11-point scale (0-10). The range for the combined subscales is 0-240. (Higher total score = more pain, stiffness, and impairment)
  • Short Form Health Survey 36 (SF-36) [ Time Frame: Baseline to 6 weeks ]
    Change from baseline in the SF-36. The SF-36 is a health-related quality-of-life measure, using 8 sub-scale scores and 2 summary scores for mental and physical health. Range: 0-100 Lower = worse Eight subscales
    • vitality
    • physical functioning
    • bodily pain
    • general health perceptions
    • physical role functioning
    • emotional role functioning
    • social role functioning
    • mental health
    Subscales scores are converted to a z score and given equal weight; max total score is 100
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline to 6 weeks ]
    Change from baseline in the BDI-II. The BDI-II assesses mood in a 21-item self-administered survey. It is scored on a scale of 0-63 in a list of four statements arranged in increasing severity about a particular symptom of depression. Range 0-63 Higher = worse Subscales N/A
  • Opioid Analgesic Consumption [ Time Frame: Baseline to 6 weeks ]
    Opioid analgesic consumption during hospital stay and after discharge to end of study.
  • Discharge [ Time Frame: Baseline to 6 weeks ]
    Time to discharge.
  • Perioperative outcomes [Blood] [ Time Frame: Baseline to Day 2 ]
    Intraoperative blood products (mL)
  • Perioperative outcomes [Fluids] [ Time Frame: Baseline to Day 2 ]
    Intraoperative fluids (mL)
  • Functional status using the ActiGraph [ Time Frame: Baseline to 6 weeks ]
    Change in functional status using the ActiGraph wearable device providing measurements for physical activity, mobility, and sleep.
  • Vital sign measurements [BP] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in vital sign measurements: Blood pressure (mm Hg)
  • Vital sign measurements [Heart] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in vital sign measurements: Heart rate (bpm)
  • Electrocardiogram (ECG) [Rate] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in ECG: Rate (bpm)
  • Electrocardiogram (ECG) [Rhythm] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in ECG: Rhythm (sinus or non-sinus)
  • Electrocardiogram (ECG) [QT] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in ECG: QT interval (ms)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) [ Time Frame: Baseline to Day 3 ]
    Change from baseline in 3D-CAM. The 3D-CAM is a verbal assessment tool used to test patients for delirium. Each item in the instrument directly informs acute onset of mental status change or fluctuating course of cognition, inattention, disorganized thinking, and altered level of consciousness.
  • Surgery Recovery Scale (SRS) [ Time Frame: Baseline to 6 weeks ]
    Time to 50% recovery of the baseline value in the SRS. The SRS tool assesses functional recovery following major surgery. Impacts on daily activities are scored from 1 to 5 or 6 (1= not at all).
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Pain] [ Time Frame: Baseline to 6 weeks ]
    Time to a score of < 12/40 on the WOMAC, Pain Subscale. The WOMAC assess pain, stiffness, and physical function in patients with knee and/or hip osteoarthritis. This is an 11-point scale (0-10). The range for the Pain subscale is 0-40 . The subscales are used independently and not summed. Higher scores = worse (Higher pain score = more pain; higher function score = more impairment)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Function] [ Time Frame: Baseline to 6 weeks ]
    Time to a score of < 18/60 on the WOMAC, Physical Function Subscale. The WOMAC assess pain, stiffness, and physical function in patients with knee and/or hip osteoarthritis. This is an 11-point scale (0-10). The range for the Function subscale is 0-60 . The subscales are used independently and not summed. Higher scores = worse (Higher pain score = more pain; higher function score = more impairment)
  • Short Form Health Survey 36 (SF-36) [ Time Frame: Baseline to 6 weeks ]
    Change from baseline in the SF-36. The SF-36 is a health-related quality-of-life measure, using 8 sub-scale scores and 2 summary scores for mental and physical health. Range: 0-100 Lower = worse Eight subscales
    • vitality
    • physical functioning
    • bodily pain
    • general health perceptions
    • physical role functioning
    • emotional role functioning
    • social role functioning
    • mental health
    Subscales scores are converted to a z score and given equal weight; max total score is 100
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline to 6 weeks ]
    Change from baseline in the BDI-II. The BDI-II assesses mood in a 21-item self-administered survey. It is scored on a scale of 0-63 in a list of four statements arranged in increasing severity about a particular symptom of depression. Range 0-63 Higher = worse Subscales N/A
  • Opioid Analgesic Consumption [ Time Frame: Baseline to 6 weeks ]
    Opioid analgesic consumption during hospital stay and after discharge to end of study.
  • Discharge [ Time Frame: Baseline to 6 weeks ]
    Time to discharge.
  • Perioperative outcomes [Blood] [ Time Frame: Baseline to Day 2 ]
    Intraoperative blood products (mL)
  • Perioperative outcomes [Fluids] [ Time Frame: Baseline to Day 2 ]
    Intraoperative fluids (mL)
  • Functional status using the ActiGraph [ Time Frame: Baseline to 6 weeks ]
    Change in functional status using the ActiGraph wearable device providing measurements for physical activity, mobility, and sleep.
  • Vital sign measurements [BP] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in vital sign measurements: Blood pressure (mm Hg)
  • Vital sign measurements [Heart] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in vital sign measurements: Heart rate (bpm)
  • Electrocardiogram (ECG) [Rate] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in ECG: Rate (bpm)
  • Electrocardiogram (ECG) [Rhythm] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in ECG: Rhythm (sinus or non-sinus)
  • Electrocardiogram (ECG) [QT] [ Time Frame: Baseline to Day 3 ]
    Change from baseline in ECG: QT interval (ms)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of GRF6021 on Postoperative Recovery Following Primary Hip or Knee Arthroplasty
Official Title  ICMJE A Randomized, Placebo-Controlled, Double-Blind Pilot Study to Evaluate the Effect of GRF6021 on Intracellular Signaling Cascades in Blood Leukocytes and Postoperative Recovery Following Primary Hip or Knee Arthroplasty
Brief Summary This study will evaluate the safety, tolerability and effect of GRF6021 on clinical recovery parameters in patients undergoing primary hip or knee arthroplasty.
Detailed Description This is a randomized, placebo-controlled, double-blind pilot study to investigate the effects of GRF6021, a 5% human plasma protein fraction administered by intravenous (IV) infusion, on intracellular signaling cascades in blood leukocytes in subjects undergoing primary hip or knee arthroplasty.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Recovery
Intervention  ICMJE
  • Biological: GRF6021
    for IV infusion
  • Other: Placebo
    for IV infusion
Study Arms  ICMJE
  • Experimental: GRF6021

    Subjects will receive GRF6021 per the following schedule:

    1. On the day before surgery
    2. On the day of surgery within 4 hours before surgery start (first incision)
    3. On the day of surgery upon arrival in the postoperative care unit (within 5 hours after the first incision)
    4. On the day after surgery
    Intervention: Biological: GRF6021
  • Placebo Comparator: Placebo

    Subjects will receive Placebo per the following schedule:

    1. On the day before surgery
    2. On the day of surgery within 4 hours before surgery start (first incision)
    3. On the day of surgery upon arrival in the postoperative care unit (within 5 hours after the first incision)
    4. On the day after surgery
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2021)
38
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
45
Actual Study Completion Date  ICMJE March 4, 2021
Actual Primary Completion Date January 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women 50-85 years of age scheduled to undergo primary total hip or knee replacement surgery.
  • Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 .

Exclusion Criteria:

  • Blood coagulation disorders.
  • Subjects who started chronic anticoagulant therapy (warfarin, heparin, low-molecular weight heparin, or Factor Xa inhibitors) in the last 6 months
  • Hypercoagulable state.
  • Prior hypersensitivity to any human blood product including plasma.
  • Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
  • History of immunoglobulin A or haptoglobin deficiency.
  • Major surgery, trauma or injury in the last 3 months or minor surgery in the last 1 month.
  • Heart disease or congestive heart failure in the 6 months prior to dosing.
  • Poorly controlled hypertension.
  • Severe anemia.
  • Functional impairment of major joint or lower extremity other than joint undergoing surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981419
Other Study ID Numbers  ICMJE AKST6021-211
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alkahest, Inc.
Study Sponsor  ICMJE Alkahest, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alkahest Medical Monitor Alkahest, Inc.
PRS Account Alkahest, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP