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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2021-03-04

Brief Summary

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This study will evaluate the safety, tolerability and effect of GRF6021 on clinical recovery parameters in participants undergoing primary hip or knee arthroplasty.

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Detailed Description

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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 participants undergoing primary hip or knee arthroplasty.

Conditions

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Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GRF6021

Participants received 4 doses of GRF6021, 250 milliliters (mL), intravenous (IV) infusion. The first dose was administered on day before surgery, the next two doses on the day of surgery i.e., within 4 hours before start of surgery (first incision), and then upon arrival in the postoperative care unit (within 5 hours after the first incision) and the last dose was administered on the day after the surgery.

Group Type EXPERIMENTAL

GRF6021

Intervention Type BIOLOGICAL

for IV infusion

Placebo

Participants received 4 doses of GRF6021 matching placebo, 250 mL, IV infusion. The first dose was administered on day before surgery, the next two doses on the day of surgery i.e., within 4 hours before start of surgery (first incision), and then upon arrival in the postoperative care unit (within 5 hours after the first incision) and the last dose was administered on the day after the surgery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

for IV infusion

Interventions

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GRF6021

for IV infusion

Intervention Type BIOLOGICAL

Placebo

for IV infusion

Intervention Type OTHER

Eligibility Criteria

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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.
* Participants 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No