Back to resultsClinical Study of Lyophilized Plasma in Patients With Liver Disease
Primary Purpose
Liver Disease
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lyophilized Plasma
Licensed Plasma
Sponsored by
About this trial
This is an interventional supportive care trial for Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female patients at least 18 years of age.
- Patients with liver disease.
- Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
- Patients with an elevated international normalized ratio due to liver disease.
- 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.
- Patients able and willing to comply with the procedures laid out in the study protocol.
Exclusion Criteria:
- Patients who are clinically unstable.
- Patients who have received mediations that could interfere with results of laboratory testing.
- Patients who have congenital or acquired coagulopathies of non-hepatic origin.
- Pregnant or nursing women.
- Active illicit drug use.
- Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
- Patients previously enrolled in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Licensed Plasma
Lyophilized Plasma
Arm Description
Outcomes
Primary Outcome Measures
Assess and compare adverse events
The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control.
Secondary Outcome Measures
Full Information
NCT ID
NCT01547078
First Posted
February 10, 2012
Last Updated
March 17, 2015
Sponsor
HemCon Medical Technologies, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01547078
Brief Title
Clinical Study of Lyophilized Plasma in Patients With Liver Disease
Official Title
A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HemCon Medical Technologies, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Licensed Plasma
Arm Type
Active Comparator
Arm Title
Lyophilized Plasma
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Lyophilized Plasma
Intervention Description
Licensed plasma that has been lyophilized.
Intervention Type
Biological
Intervention Name(s)
Licensed Plasma
Intervention Description
Plasma that has been authorized for transfusion.
Primary Outcome Measure Information:
Title
Assess and compare adverse events
Description
The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control.
Time Frame
Duration of Study (Less than or equal to 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients at least 18 years of age.
Patients with liver disease.
Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
Patients with an elevated international normalized ratio due to liver disease.
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.
Patients able and willing to comply with the procedures laid out in the study protocol.
Exclusion Criteria:
Patients who are clinically unstable.
Patients who have received mediations that could interfere with results of laboratory testing.
Patients who have congenital or acquired coagulopathies of non-hepatic origin.
Pregnant or nursing women.
Active illicit drug use.
Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
Patients previously enrolled in this study.
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Lyophilized Plasma in Patients With Liver Disease
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