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Trial record 3 of 7 for:    alkahest

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

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ClinicalTrials.gov Identifier: NCT03981419
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alkahest, Inc.

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.

Condition or disease Intervention/treatment Phase
Postoperative Recovery Biological: GRF6021 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : August 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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
Biological: GRF6021
for IV infusion

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
Other: Placebo
for IV infusion




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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)


  4. 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)


  5. 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


  6. 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


  7. Opioid Analgesic Consumption [ Time Frame: Baseline to 6 weeks ]
    Opioid analgesic consumption during hospital stay and after discharge to end of study.

  8. Discharge [ Time Frame: Baseline to 6 weeks ]
    Time to discharge.

  9. Perioperative outcomes [Blood] [ Time Frame: Baseline to Day 2 ]
    Intraoperative blood products (mL)

  10. Perioperative outcomes [Fluids] [ Time Frame: Baseline to Day 2 ]
    Intraoperative fluids (mL)

  11. 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.

  12. Vital sign measurements [BP] [ Time Frame: Baseline to Day 3 ]

    Change from baseline in vital sign measurements:

    Blood pressure (mm Hg)


  13. Vital sign measurements [Heart] [ Time Frame: Baseline to Day 3 ]

    Change from baseline in vital sign measurements:

    Heart rate (bpm)


  14. Electrocardiogram (ECG) [Rate] [ Time Frame: Baseline to Day 3 ]

    Change from baseline in ECG:

    Rate (bpm)


  15. Electrocardiogram (ECG) [Rhythm] [ Time Frame: Baseline to Day 3 ]

    Change from baseline in ECG:

    Rhythm (sinus or non-sinus)


  16. Electrocardiogram (ECG) [QT] [ Time Frame: Baseline to Day 3 ]

    Change from baseline in ECG:

    QT interval (ms)




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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
  • 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.
  • Anemia.
  • Functional impairment of major joint or lower extremity other than joint undergoing surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981419


Contacts
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Contact: Alkahest Clinical Trials 650.801.0474 trials@alkahest.com

Locations
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United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94305
Contact: Martha Tingle       mtingle@stanford.edu   
Sponsors and Collaborators
Alkahest, Inc.
Investigators
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Study Director: Alkahest Medical Monitor Alkahest, Inc.

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Responsible Party: Alkahest, Inc.
ClinicalTrials.gov Identifier: NCT03981419     History of Changes
Other Study ID Numbers: AKST6021-211
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkahest, Inc.:
Total hip replacement
Total knee replacement