Efficacy and Safety of Resatorvid in Patients With Sepsis-induced Cardiovascular and Respiratory Failure

NCT00633477 | Terminated Phase 3 Results DMC

• 3 other identifiers: TAK-242_3012007-005687-27U1111-1127-6016
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of resatorvid on subjects with sepsis.

Conditions

Sepsis

Keywords

Systemic Inflammatory Response Syndrome; Septic Shock; Septicemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  Mortality regardless of cause at Day 28

  Day 28

Secondary Outcomes (3)

• ICU Free Days

  Day 28

• Vasopressor Free Days.

  Day 28

• Ventilator Free Days.

  Day 28

Study Arms (2)

Resatorvid 2.4 mg/kg/day

EXPERIMENTAL

Drug: Resatorvid

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Resatorvid DRUG

Resatorvid 1.2 mg/kg emulsion, injection for 30 minutes and resatorvid 2.4 mg/kg per-day emulsion, injection, continuous infusion for 96 hours.

Also known as: TAK-242

Resatorvid 2.4 mg/kg/day

Placebo DRUG

Resatorvid placebo-matching emulsion, injection for 30 minutes and resatorvid placebo-matching emulsion, injection, continuous infusion for 96 hours.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or proven bacterial or fungal infection for which patient is receiving parenteral antimicrobial therapy.
• Developed at least 3 of the 4 following systemic inflammatory response syndrome criteria within 36 hours prior to start of study drug administration:
• A temperature from any site greater than 38°C (greater than 100.4°F) or a core temperature less than 36°C (less than 96.8°F).
• Heart rate of greater than 90 beats per minute. If subject has a known medical condition (eg, heart block) or is receiving treatment (eg, beta blocker) that would prevent tachycardia, only 2 of the remaining 3 criteria for systemic inflammatory response syndrome must be met.
• Respiratory rate of greater than 20 breaths per min or arterial partial pressure of carbon dioxide of less than 32 mm Hg or mechanical ventilation for an acute process.
• A total white blood cell absolute count greater than 12,000 cells per mm3 or less than 4,000 cells/mm3; or a white blood cell differential count showing greater than 10% immature (band) forms.
• Has septic shock diagnosed within 36 hours prior to study drug administration..
• Has developed respiratory failure within 36 hours prior to study drug administration.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

You may not qualify if:

• Received any investigational compound within 30 days (or 5 half-lives of the drug, whichever is longer) prior to the initiation of the study drug infusion or is participating in another investigational study, not including investigational compound, without prior approval from the Vanderbilt Coordinating Center or the sponsor.
• Currently receiving any immunosuppressive therapy (excluding glucocorticoids) such as methotrexate, azathioprine, anti tumor necrosis factor alpha, or a cancer related chemotherapeutic agent.
• Known history of glucose-6-phosphate dehydrogenase deficiency.
• Methemoglobin level of greater than or equal to 5% at pretreatment period or has a known history of methemoglobinemia.
• Moribund and death is considered imminent.
• Prior to the onset of sepsis, the subject would not otherwise have been expected to survive 28 days or to complete a functional recovery due to a pre-existing unstable medical condition (eg, a recent acute cerebral hemorrhage or infarct, a recent acute unstable myocardial infarction, severe traumatic injury).
• Poorly controlled or metastatic neoplasm.
• The participant, the participant's family or physician is not committed to full aggressive management or the presence of an unstable medical condition makes the receipt of full aggressive management support unlikely in the view of the coordinating center.
• Severe end stage chronic respiratory failure or lung disease that significantly impairs physical functioning equivalent to that of New York Heart Association functional classification III or IV.
• Documented history of moderate to severe chronic heart failure as defined by New York Heart Association functional classification III or IV.
• Received electrocardioversion for a pulse-less rhythm or chest compressions during their current hospitalization.
• Known to be immunocompromised such as subjects with human immunodeficiency virus and a CD4 count less than 50 mm3, primary immune deficiency or chronic lymphocytic leukemia.
• Chronic end stage hepatic failure or significant sequelae of chronic hepatic failure (eg, esophageal varices, jaundice, chronic ascites) or Child-Pugh hepatic impairment Classification C.
• In a chronic vegetative state or has a similar long-term neurological impairment, where continued aggressive care would be unlikely.
• Acute third degree burns involving more than 30% of body surface area within 120 hours of first qualifying organ failure.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Nagasaki, Japan

Location

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome; Shock, Septic

Interventions

ethyl 6-(N-(2-chloro-4-fluorophenyl)sulfamoyl)cyclohex-1-ene-1-carboxylate

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Takeda Study Registration Call Center
• Organization: Takeda

medicalinformation@tpna.com

800-778-2860

Study Officials

• VP Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 18, 2013
• Results First Posted: January 9, 2013

Record last verified: 2013-01

Locations

JP (1)