Clinical trial NCT01199744: Relenza® Sentinel Site Monitoring Program in Japan
Official title: Collection of Patients' Background InformationRelenza® Sentinel Site Monitoring Program in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Keywords: Influenza
Relenza®
SSMP
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 1575
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1600 cases (of which 90 shall be pregnant women)

Brief summary: To collect background information of patients receiving a prescription for Relenza® and study risk factors etc. for adverse drug reactions collected through spontaneous reporting. In particular, to characterize the types and incidences of adverse events, serious adverse events, and adverse drug reactions and to investigate risk factors for them in patient populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the use experience of Relenza® has not been enough (such as pregnant women, infants, elderly persons, and those with decreased physical function) in accordance with the PFSB/SD Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW, dated 4th September 2009.

To compare the data with the safety data collected in overseas sentinel site monitoring programs.

Detailed description: 1. Objectives To collect background information of patients receiving a prescription for Relenza® and study risk factors etc. for adverse drug reactions collected through spontaneous reporting. In particular, to characterize the types and incidences of adverse events, serious adverse events, and adverse drug reactions and to investigate risk factors for them in patient populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the use experience of Relenza® has not been enough (such as pregnant women, infants, elderly persons, and those with decreased physical function) in accordance with the PFSB/SD Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW, dated 4th September 2009.

   To compare the data with the safety data collected in overseas sentinel site monitoring programs.
2. Planned number of patients Planned number of patients: 1,600 cases (of which 90 shall be pregnant women)
3. Target patients All patients who visit a sentinel site between the date of the contract and 31st March 2010 and are prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza.
4. Planned number of sentinel sites About 20 sites, mainly obstetrics, pediatrics, and internal medicine.
5. Method 1)The sentinel sites to participate in the monitoring program will be selected from medical institutions which has adopted/purchased Relenza®. Physicians who are capable of fulfilling the objectives of the program satisfactorily will be given information concerning the purpose, target patients, data to be collected, method, etc. and asked for cooperation.

2)Upon receiving consent of the physician for cooperation, a written contract will be concluded with the head of the site (e.g., hospital director) before collection of patient background information is started.

3)All patients receiving a prescription of Relenza® during the contract term at the respective site (i.e., from the date of contract until 31st March 2010) will be included in the monitoring program. At sentinel sites with obstetrics service, all pregnant women receiving a prescription of Relenza® during the contract term at the respective site (i.e., from the date of contract until 31st March 2010) will be included in the monitoring program in order to focus on collection of data in pregnant women.

4)Physician in charge will enter the data such as the background information of the patients who have received prescription of Relenza® from the date of contract until 31st March 2010 into the electronic data collection (EDC) system, check the data, and transmit them to GlaxoSmithKline K.K.

5)The period of observation is 11 days after prescription of Relenza®. 6)Information about cases with adverse events and use of Relenza® during pregnancy shall be reported separately through spontaneous ADR reporting system.

6.Planned monitoring period November 2009 to 31st March 2010 The data collection will be concluded before 31st March 2010 when the requisite number of patients is accrued ahead of schedule.

7.Data to be collected

1. Patient identification number to identify each patient.
2. Reason for the use of Relenza® (prophylaxis or treatment); if Relenza® is used for the treatment: information whether or not influenza virus test was performed in the clinical laboratory; if yes, result of the influenza virus test (Pandemic Flu (H1N1) or Seasonal Flu).
3. Patient background information : Birth year, sex (if female: pregnant or not pregnant, breastfeeding or not breastfeeding), body height, body weight, complications (if yes: bronchial asthma, chronic obstructive pulmonary disease, immune deficiency disease \[if yes: HIV infection, organ transplant, congenital immunodeficiency, hematological malignancy, autoimmune disease, chemotherapy\], others), route of infection (family infection or group infection), influenza vaccination status (if vaccinated: date of vaccination, generic name or brand name of the vaccine used).
4. Prescription information for Relenza®: Relenza® dose, dosing frequency per day, Relenza® initiation date, last date of administration)
5. Date of patient contact; was a contact with the patient established? (if yes, type of contact \[telephone, e-mail, in person\]).
6. Adverse events information If adverse events are reported, information concerning the circumstance of the adverse event shall be reported separately in the form of spontaneous reporting.
7. Concomitant medications during Relenza® treatment (generic name or trade name of the drug, reason for the use of the drug, dose, dosing frequency per day, unit, initiation date, last date of administration, still on the medication, use for the treatment of adverse event)
8. Completion or discontinuation of data collection
9. If Relenza® is used during pregnancy, the course of pregnancy and delivery, abortion, etc. adverse events observed in mother and/or infant shall be reported separa

Eligibility criteria: Inclusion Criteria:

Prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza

Exclusion Criteria:

N/A

Primary outcomes:
measure: Number of Participants With Any Adverse Drug Reaction
timeFrame: 5 months (November 2009 to March 2010)
Secondary outcomes:
measure: Number of Participants With Any Serious Adverse Drug Reaction (ADR)
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Risk Factors for Influenza or Having no Risk Factors
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza
timeFrame: 5 months (November 2009 to March 2010)
measure: Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications
timeFrame: 5 months (November 2009 to March 2010)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Medicine and Drug Journal Vol.46 No.12 p.136-142, 2010