Octaplas Pediatric Plasma Replacement Trial

NCT02050841 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: LAS-212
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors. Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver surgery.

Conditions

Liver Surgery; Liver Dysfunction; Coagulopathy; Cardiac Surgery

Keywords

Pediatric; patients; replacement; coagulation factors; plasma; s/d plasma; Octaplas; plasma replacement

Outcome Measures

Primary Outcomes (10)

• Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)

  up to 6 days

• Monitoring of Clinically Significant Changes in White Blood Cells

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Red Blood Cells

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Hemoglobin

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Hematocrit

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

• Monitoring of Clinically Significant Changes in Platelets

  Assesses Pre- and Post-infusion for Infusion Episode 1

  up to 6 days

Secondary Outcomes (11)

• Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)

  up to 6 days

• Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)

  up to 6 days

• Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).

  up to 6 days

• Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)

  up to 6 days

• Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.

  up to 6 days

Study Arms (1)

Octaplas

EXPERIMENTAL

Qualified patients will receive Octaplas as per protocol.

Biological: octaplas

Interventions

octaplas BIOLOGICAL

Octaplas S/D Plasma

Octaplas

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient requiring liver or cardiac surgery and/or patient with liver dysfunction associated with coagulopathy in whom replacement of multiple coagulation factors is required.
• Voluntarily given, written and signed informed consent by the patient's legal representative(s) or guardian(s). Children deemed old enough by the Investigator/institution to understand the risks and benefits of the study should also be made aware of the risks/benefits of the study and provide written assent.
• Male or female patient ≤ 16 years of age.

You may not qualify if:

• Patient with known homozygous congenital deficiency of protein S.
• Patient has a history of hypersensitivity reaction to blood or plasma-derived products or to any excipient of the investigational product.
• Patient has an already known IgA (Immunoglobulin A) deficiency with documented antibodies against IgA.
• Patient has a congenital factor deficiency or platelet disorder requiring plasma treatment.
• Patient is currently participating in another study investigating a new drug product or another interventional clinical study that may impact coagulation factors or has participated during the last three (3) months.
• Patient is on ECMO (Extracorporeal Membrane Oxygenation) when plasma is ordered by the treating physician for the first infusion episode.
• Patient is pregnant.
• Patient is predicted to require massive blood transfusion defined as more than 40 mL per kilogram of all blood products in a 24-hour period
• Patient is receiving plasma exchange, therapeutic plasma exchange (TPE) or plasmapheresis.
• Patient is a premature neonate defined as less than 37 weeks gestation.
• Cardiac surgery patients who develop the need for plasma replacement greater than 72 hours after the end of the associated cardiac surgery and do not have coagulopathy due to hepatic dysfunction.

Sponsors & Collaborators

• Octapharma: lead

Study Sites (4)

Octapharma Research Site

Birmingham, Alabama, 35233, United States

Location

Octapharma Research Site

Atlanta, Georgia, 30322, United States

Location

Octapharma Research Site

Minneapolis, Minnesota, 55455, United States

Location

Octapharma Research Site

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Spinella PC, Borasino S, Alten J. Solvent/Detergent-Treated Plasma in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors: An Open-Label, Multicenter, Post-marketing Study. Front Pediatr. 2020 Sep 17;8:572. doi: 10.3389/fped.2020.00572. eCollection 2020.

  PMID: 33042916 DERIVED

MeSH Terms

Conditions

Liver Diseases; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Michael Eppolito
• Organization: Octapharma

michael.eppolito@octapharma.com

2016041155

Study Officials

• Wolfgang Frenzel

  International Medical Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 31, 2014
• Study Start: December 1, 2014
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: June 23, 2020
• Results First Posted: March 25, 2019

Record last verified: 2020-06

Locations

US (4)