Placebo-controlled Randomized Trial to evaluate the Effect of Elafin on Cytokine Profiles after Major Surgery - Phase II - Elafi

• Conditions: Esophagectomy is the surgical removal of all or part of the esophagus. The patients enrolled in the study will undergo this surgery for treatment of esophageal cancer. The condition under investigation is the postoperative inflammatory syndrome (SIRS) after esophagectomy.

• Registration Number: EUCTR2008-000938-49-DE
• Lead Sponsor: Proteo Biotech AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-27
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Subject has carcinoma of the esophagus that will be treated with esophagectomy
2.Subject is informed and given ample time and opportunity to think about his participation and has given his written informed consent.
3.Subject is willing and able to comply with all trial requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Less than 18 years of age
2.Child-bearing potential
3.Participation in another trial with an investigational product within the last 4 weeks
4.White blood cell count < 4,000 cells/mm³
5.White blood cell count > 12,000 cells/mm³
6.Greater than 10% immature neutrophils
7.Body temperature > 38°C
8.Body temperature < 36°C
9.Pulse rate > 90 bpm at eligibility
10.Serum creatinine > 2.0 mg/dL
11.Severe chronic liver disease
12.Severe central nervous system or severe psychiatric disease
13.Impaired spontaneous ventilation
14.Acute myocardial infarction within the last 6 weeks
15.Known heart failure, NYHA Classification III or IV
16.Active infection requiring systemic administration of antibiotics
17.Previous bone marrow transplant
18.Previous organ transplant (heart, kidney, liver)
19.Current immunosuppressive therapy such as cortisone, cyclosporine or azothioprine
20.Cancer-related chemotherapy within the last 2 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified