Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Alkahest, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: GRF6021
  • Other: Placebo

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

50 Years - 85 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Martha Tingle
Not Recruiting