Pharmacokinetics and Pharmacodynamics of MTR105 in Hypote... | NCT00482287

Studies
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

NCT00482287

Sponsor

Meditor Pharmaceuticals Ltd.

Status

Withdrawn

Last Update Posted

Apr 7, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Hypotension
Cardiopulmonary Bypass

Interventions

MTR105

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Site did not recruit any patients

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 1, 2007

First Submission Date that Met QC Criteria

Jun 1, 2007

First Posted Date

Jun 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.

Detailed Description

The study is a prospective, randomized, four-arm, dose-escalating, double blind, placebo controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of four dose levels of MTR105 in patients undergoing cardiac surgery utilizing cardiopulmonary bypass presenting hypotension upon weaning off bypass.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Dose level 0.3 mg/kg with 6 active and 2 placebo	Drug: MTR105
2	Other	Dose level 0.6 mg/kg 6 patients active and 2 placebo	Drug: MTR105
3	Other	Dose level 1.2 mg/kg 6 active and 2 placebo	Drug: MTR105
4	Other	Dose level 2.4 mg/kg 6 active and 2 placebo	Drug: MTR105

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MTR105	Drug	Intravenous administration, dose escalating (4 arms), single dose	1 2 3 4

Measure	Description	Time Frame
Hemodynamic parameters		24 hours

Measure	Description	Time Frame
Pharmacokinetics		10 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men or women age 18 years or older
Referred for cardiac surgery requiring the use of CPB.
Elective or urgent surgeries (non emergency operations).
LVEF ≥40 based on cardiac catheterization results
Normal renal function at study entry
Normal hepatic function (within normal laboratory ranges) at study entry
Normal coagulation status at study entry as judged by PT, PTT, fibrinogen and platelet count.
Willingness to participate in the study and adhere to the study design.
Willingness to sign an informed consent form.

Exclusion Criteria:

Emergency operation
Pulmonary hypertension (PA systolic pressure >60 mmHg)
Ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8
Neurological events such as prior CVA, TIA or symptomatic carotid stenosis within 1 year of presenting for surgery
Body weight <40 Kg
Pregnancy
Malignancy within 1 year of presenting for surgery
Systemic infection as evidenced by elevated WBC or fever >38.5 C
Usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction.
Participation in any other investigational drug or device study within 30 days of randomization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Penny Sappington, MD	University of Pittsburgh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15213	United States

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases