Proven Efficacy With Mulpleta in Two Clinical Trials

The efficacy of Mulpleta was established in two randomized, double-blind, placebo-controlled trials (L-PLUS 1, L-PLUS 2)1,2

L-PLUS 1 and L-PLUS 2 study design

Patients undergoing laparotomy, thoracotomy, open-heart surgery, craniotomy, or organ resection were excluded. Patients with a history of splenectomy, partial splenic embolization, or thrombosis and those with Child-Pugh class C liver disease, absence of hepatopetal blood flow, or a prothrombotic condition other than chronic liver disease were not allowed to participate.

Randomization was stratified by liver ablation/coagulation or other procedures and the platelet count at screening/baseline.

Primary endpoint1

  • L-PLUS 1: Proportion of patients who required no platelet transfusion§ prior to the primary invasive procedure
  • L-PLUS 2: Proportion of patients who required no platelet transfusion§ prior to the primary invasive procedure and no rescue therapy for bleeding from randomization through 7 days after the primary invasive procedure

§Platelet transfusion was required if the platelet count was <50,000/μL.

Rescue therapy: Platelet preparations; other blood preparations, including red blood cells and plasma; volume expanders.

Procedures performed after treatment with Mulpleta1

In patients treated with Mulpleta, 95% of procedures were performed within the scheduled period.2

VIEW PROCEDURES

The majority of patients avoided platelet transfusion1

A significantly greater proportion of patients treated with Mulpleta avoided platelet transfusion vs placebo

L-PLUS 1 and L-PLUS 2 primary endpoint

The majority of patients achieved platelet count ≥50,000/μL1

A significantly greater proportion of patients treated with Mulpleta reached a platelet count of ≥50,000/μL and had a minimum increase of 20,000/μL from baseline vs placebo

L-PLUS 1 and L-PLUS 2 responder endpoint

Patients maintained platelet count ≥50,000/μL1,2

Duration of platelet count ≥50,000/μL was longer with Mulpleta* vs placebo

L-PLUS 1 and L-PLUS 2 platelet count duration
  • In patients treated with Mulpleta without platelet transfusion, mean (SD) time to reach maximum platelet count was 13.4 (3.8) days in L-PLUS 1 (n=38) and 12.4 (4.7) days in L-PLUS 2 (n=74)2
Safety

The safety profile of Mulpleta
was similar to placebo.