CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
MP4OX +2 moredrug
Likely dose
MP4OX 4.3 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01004198
NCT01004198Phase 2Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind, Controlled Dose-finding Study to Evaluate the Safety and Efficacy of MP4OX Treatment Plus Standard of Care in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock

Sangart·interventional·Posted Oct 29, 2009·Updated Aug 19, 2013

In Brief

A Phase 2 clinical trial evaluating MP4OX and Ringers Lactate solution for Shock, Hemorrhagic and 2 related conditions. Completed, enrolled 51 participants across 13 sites in 4 countries.

Detailed Summary

MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. MP4OX is a pegylated hemoglobin-based colloid and and as a result of its molecular size and unique oxygen dissociation characteristics, targets oxygen delivery to ischemic tissues by selectively off-loading oxygen in tissues predisposed to low oxygen tension. Sangart is currently evaluating MP4OX to reduce organ dysfunction and failure in trauma patients with lactic acidosis due to severe hemorrhagic shock.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShock, Hemorrhagic, Shock, Traumatic, Acidosis, Lactic
CountriesFrance, Germany, South Africa, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2009
Enrollment StartDec 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.7 years ago

Interventions

MP4OXdrug

4.3 g/dL PEG-Hb solution in lactated electrolyte solution

MP4OXdrug

4.3 g/dL PEG-Hb solution in lactated electrolyte solution

Ringers Lactate solutiondrug

Ringers Lactate solution for Injection