NCT03981419

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Alkahest, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Postoperative Recovery

Interventions

Type	Name	Description
BIOLOGICAL	GRF6021	for IV infusion
OTHER	Placebo	for IV infusion

Timeline

• Start date: 2019-07-12
• Primary completion: 2021-01-23
• Completion: 2021-03-04
• First posted: 2019-06-10
• Last updated: 2024-03-13
• Results posted: 2024-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study