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

Alkahest

Status and phase: Completed; Phase 2

Conditions: Postoperative Recovery

Treatments: Biological: GRF6021; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03981419

AKST6021-211

Details and patient eligibility

About

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

Full 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 participants undergoing primary hip or knee arthroplasty.

Enrollment: 38 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

GRF6021

Experimental group

Description:

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.

Treatment:

Biological: GRF6021

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo