Clinical Study of Lyophilized Plasma in Patients With Liver Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by HemCon Medical Technologies, Inc
Sponsor:
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:
NCT01547078
First received: February 10, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.


Condition Intervention Phase
Liver Disease
Biological: Lyophilized Plasma
Biological: Licensed Plasma
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease

Resource links provided by NLM:


Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:
  • Assess and compare adverse events [ Time Frame: Duration of Study (Less than or equal to 7 days) ] [ Designated as safety issue: Yes ]
    The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control.


Estimated Enrollment: 100
Study Start Date: January 2015
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Licensed Plasma Biological: Licensed Plasma
Plasma that has been authorized for transfusion.
Experimental: Lyophilized Plasma Biological: Lyophilized Plasma
Licensed plasma that has been lyophilized.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients at least 18 years of age.
  2. Patients with liver disease.
  3. Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
  4. Patients with an elevated international normalized ratio due to liver disease.
  5. Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
  6. Patients able and willing to comply with the procedures laid out in the study protocol.

Exclusion Criteria:

  1. Patients who are clinically unstable.
  2. Patients who have received mediations that could interfere with results of laboratory testing.
  3. Patients who have congenital or acquired coagulopathies of non-hepatic origin.
  4. Pregnant or nursing women.
  5. Active illicit drug use.
  6. Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
  7. Patients previously enrolled in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547078

Contacts
Contact: Jody Oyama jody.oyama@hemcon.com

Sponsors and Collaborators
HemCon Medical Technologies, Inc
  More Information

No publications provided

Responsible Party: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT01547078     History of Changes
Other Study ID Numbers: 2011-I-LyP-2
Study First Received: February 10, 2012
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 22, 2014