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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00143611




Registration number
NCT00143611
Ethics application status
Date submitted
31/08/2005
Date registered
2/09/2005
Date last updated
2/02/2012

Titles & IDs
Public title
Efficacy & Safety of Resatorvid in Adults With Severe Sepsis
Scientific title
A Pivotal, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety of TAK-242 in Adults With Severe Sepsis
Secondary ID [1] 0 0
2005-003561-16
Secondary ID [2] 0 0
01-04-TL-242-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Resatorvid
Treatment: Drugs - Resatorvid
Treatment: Drugs - Placebo

Experimental: Resatorvid 1.2 mg/kg/day -

Experimental: Resatorvid 2.4 mg/kg/day -

Placebo Comparator: Placebo -


Treatment: Drugs: Resatorvid
Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.05 mg/kg/h (1.2 mg/kg/day), injection, subcutaneously over 96 hours.

Treatment: Drugs: Resatorvid
Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.1 mg/kg/h (2.4 mg/kg/day), injection, subcutaneously over 96 hours.

Treatment: Drugs: Placebo
Resatorvid placebo-matching injection, subcutaneously for thirty minutes; then resatorvid placebo-matching injection, subcutaneously over 96 hours.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
28-day All-cause Mortality.
Timepoint [1] 0 0
Day 28
Secondary outcome [1] 0 0
Change from Baseline in Organ Failure Assessment
Timepoint [1] 0 0
Day 28
Secondary outcome [2] 0 0
Mean Systemic Inflammatory Response
Timepoint [2] 0 0
Day 28
Secondary outcome [3] 0 0
Mean Vasopressor-free days
Timepoint [3] 0 0
Day 28
Secondary outcome [4] 0 0
Mean Ventilator-free days
Timepoint [4] 0 0
Day 28
Secondary outcome [5] 0 0
Mean Intensive Care Unit free days
Timepoint [5] 0 0
Day 28
Secondary outcome [6] 0 0
Mean Discharge Status.
Timepoint [6] 0 0
Day 28

Eligibility
Key inclusion criteria
- Has clinical evidence of infection defined as the presence of a known or probable
source of infection requiring the initiation of parenteral antimicrobial therapy.

- Must meet at least 3 of the following 4 criteria for SIRS:

- A core temperature greater than 38°C or less than 36°C.

- A heart rate greater than 90 beats per minute.

- A respiratory rate greater than 20 breaths/min or partial pressure of carbon
dioxide in arterial blood less than 32 mm Hg or mechanical ventilation for an
acute process.

- A total white blood cell absolute count greater than 12,000 cells/mm3 or less
than 4,000 cells/mm3, or a white blood cell differential count that showed
greater than 10% immature (band) forms.

- Must have sepsis with shock and/or respiratory failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- If female, the subject is pregnant, nursing and the milk is intended to be ingested by
the infant, or the participant plans to become pregnant, or nurse and the milk is
intended to be ingested by the infant.

- Is receiving immunosuppressive therapy such as cyclosporine, azathioprine, or
cancer-related chemotherapy.

- Has a granulocyte count of less than 1000/mm3 except if the decreased count was
believed to be due to sepsis.

- Has documented or suspected acute myocardial infarction within the last 6 weeks prior
to Pretreatment Period.

- Has a documented history of moderate to severe chronic heart failure as defined by New
York Heart Association Functional Classification III or IV.

- Is known to be positive for human immunodeficiency virus with known CD4 count less
than or equal to 50/mm3 or had known end-stage processes.

- Has a known history of glucose-6-phosphate dehydrogenase deficiency.

- Has a methemoglobin level greater than 5% at Pretreatment Period or had a known
history of methemoglobinemia.

- Is moribund and death was considered imminent.

- Is classified as "Do Not Resuscitate", or "Do Not Treat", or the participant's family
has not committed to aggressive management of the participant's condition.

- Is not expected to survive for 28 days and was not likely be given life support due to
a pre-existing, uncorrectable medical condition.

- Has a known esophageal varices, chronic jaundice, cirrhosis, or chronic ascites.

- Is in a chronic vegetative state or has a similar long-term neurological condition.

- Has known portal hypertension or Child-Pugh hepatic impairment class C.

- Has acute third degree burns involving more than 30% of body surface within 120 hours
prior to Pretreatment Period.

- Has known hypersensitivity to sulfonamides.

- Has known hypersensitivity to components of resatorvid.

- Has participated in any other investigational study (drug or device) and/or taken any
investigational drug within 30 days or 5 half-lives of the drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
277
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Fremantle
Recruitment hospital [3] 0 0
- Heidelberg
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- Adelaide
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- Fremantle
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- Heidelberg
Recruitment outside Australia
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day
all-cause mortality in subjects with severe sepsis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00143611
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
VP Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00143611