Clinical Study of Lyophilized Plasma in Patients With Liver Disease

Liver Disease Clinical Trial

Official title:

A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01547078
• Other study ID #: 2011-I-LyP-2
• Status: Withdrawn
• Phase: Phase 2
• First received: February 10, 2012
• Last updated: March 17, 2015
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2015
• Source: HemCon Medical Technologies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Biological:
• Lyophilized Plasma
Licensed plasma that has been lyophilized.
• Licensed Plasma
Plasma that has been authorized for transfusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HemCon Medical Technologies, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess and compare adverse events	The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control.	Duration of Study (Less than or equal to 7 days)	Yes