A double blind, randomized, placebo controlled, multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in immunocompromised patients. - ND

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2006-002473-47-IT
• Date of registration: 12/04/2007
• Prospective Registration: Yes
• Primary sponsor: ROCHE
• Public title: A double blind, randomized, placebo controlled, multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in immunocompromised patients. - ND
• Scientific title: A double blind, randomized, placebo controlled, multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in immunocompromised patients. - ND
• Date of first enrolment: 17/12/2007
• Target sample size: 470
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002473-47
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: prospettico If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Estonia, France, Germany, Hungary, Italy, Lithuania, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Age greater than or equal to 1 year Negative rapid diagnostic test for influenza at baseline Immunocompromised subject defined as documented - SOT liver, kidney or both recipient OR - Allogenic HSCT Receiving ongoing immunosuppression, OR, in the investigator s opinion, not immune reconstituted Parent/guardian willing and able to comply with study requirements and give consent country specific age cut off . Subject able to comply with study requirements and willing to give assent for minors, country specific age cut off , as appropriate For adult subjects, willing and able to comprehend and give written informed consent Subjects, in the reproductive age group, must agree to utilize an effective method of contraception throughout the study period and for one reproductive cycle following cessation of study therapy Females of childbearing potential must have a negative urine pregnancy test prior to start of study medication
Are the trial subjects under 18? yes
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:
Symptoms suggestive of influenza-like illness including but not limited to fever, cough, or nasal congestion Subjects with fever temperature 37.8 deg Celsius Influenza vaccination in the 4 weeks prior to randomization Positive rapid diagnostic test for influenza SOT within 6 months of the time of randomization SOT other than liver, kidney or liver and kidney Have in the investigator s opinion experienced acute rejection in the 4 weeks prior to randomization HSCT patients with no evidence of engraftment engraftment is defined as the point at which a patient can maintain a sustained absolute neutrophil count ANC of 500/mm3 and sustained platelet count of 20,000/mm3, lasting 3 consecutive days without transfusions HSCT subjects not discharged from hospital after their initial hospitalization for transplantation Have evidence of veno-occlusive disease, acute or chronic extensive graft versus host disease Appendix 1 Currently or previously in the six months prior to randomization administered lymphocyte depleting antibodies example antithymocyte globulin, antilymphocyte globulin for management of transplant Have other co-morbid conditions that could affect patient survival or graft function including but not limited to a post-transplant lymphoproliferative disease PTLD , autoimmune disease including inflammatory bowel disease and psoriasis, untreated thyroid disease, and significant active infection Estimated creatinine clearance 10 ml/min in adults or 10 ml/min/1.73 M2 in children Cockroft-Gault equation for adults and the Schwartz equation in children Appendix 1 Patients currently receiving any form of renal replacement therapy including haemodialysis, peritoneal dialysis or haemofiltration Have evidence of active or uncontrolled opportunistic infections bacterial, fungal, or viral - including cytomegalovirus CMV or polyoma virus BKV at the time of randomization. Patients with HCV or HBV are not excluded. Patients with known HIV infection Patients who are being evaluated or treated for an active malignancy other than the malignancy for which the SOT or HSCT may have been performed at the time of randomization Uncontrolled vascular, neurologic, or pulmonary disease. Uncontrolled is defined as disease requiring change of therapy or hospitalization in the 4 weeks preceding randomization. Change of therapy is defined as dose increase or change of medication. Patients with severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy Allergy to the test medication Hereditary fructose intolerance for subjects who will be taking the liquid formulation Antiviral treatment example amantadine, rimantadine, zanamivir, oseltamivir and ribavirin for influenza in the 2 weeks prior to randomization Patients taking probenecid medication Patients who are pregnant or breast-feeding Participation in a clinical trial or an expanded access trial with an investigational drug in the 4 weeks prior to randomization or concomitantly with this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Seasonal prophylaxis of influenza in immunocompromised subjects
MedDRA version: 9.1 Level: LLT Classification code 10022000 Term: Influenza

Intervention(s)

Trade Name: Tamiflu
Pharmaceutical Form: Capsule, hard
Current Sponsor code: Ro 64-0796
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Tamiflu
Pharmaceutical Form: Oral powder
Current Sponsor code: Ro 64-0796
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Oral powder
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To evaluate the efficacy of oseltamivir in the seasonal prophylaxis of influenza To evaluate the safety of oseltamivir in immunocompromised subjects in the seasonal prophylaxis of laboratory confirmed clinical influenza The evaluation of isolates for phenotypic and, where necessary, genotypic, resistance

Main Objective: To evaluate the efficacy of oseltamivir in the seasonal prophylaxis of laboratory confirmed clinical influenza.

Primary end point(s): The proportion of subjects with laboratory confirmed clinical influenza in the two treatment arms.

Secondary ID(s)

2006-002473-47-HU

NV 20235