Non-Interventional Study on the Tolerability and Efficacy... | NCT02303093 | Trialant
NCT02303093
Sponsor
Octapharma
Status
Completed
Last Update Posted
Jun 29, 2021Actual
Enrollment
344Actual
Phase
Not provided
Conditions
Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Interventions
Octagam IVIG 5% or 10%
Panzyga
Countries
Austria
Canada
France
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02303093
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GAM 10-06
Secondary IDs
Not provided
Brief Title
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Official Title
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Acronym
GAM 10-06
Organization
OctapharmaINDUSTRY
Status Module
Record Verification Date
Jun 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 1, 2011Actual
Primary Completion Date
Jun 5, 2020Actual
Completion Date
Jun 5, 2020Actual
First Submitted Date
Nov 20, 2014
First Submission Date that Met QC Criteria
Nov 24, 2014
First Posted Date
Nov 27, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 5, 2021
Results First Submitted that Met QC Criteria
Jun 5, 2021
Results First Posted Date
Jun 29, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 5, 2021
Last Update Posted Date
Jun 29, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
OctapharmaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
Detailed Description
A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.
Conditions Module
Conditions
Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Keywords
Not provided
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
344Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Octagam
Patient receiving Octagam 5% or 10% IVIG
Biological: Octagam IVIG 5% or 10%
Panzyga
Patient receiving panzyga
Biological: Panzyga
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Octagam IVIG 5% or 10%
Biological
Octagam IVIG 5% or 10%
Octagam
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Adverse Drug Reactions
Number of patients with adverse drug reactions
up to one year
Secondary Outcomes
Measure
Description
Time Frame
Infection Occurrence
Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections.
Up to one year
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.
Exclusion Criteria:
None
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.
Octagam 5% and Octagam 10%, While Under Octagam 5%
Octagam 5% and Octagam 10%, while under Octagam 5%
OG003
Octagam 5% and Octagam 10%, While Under Octagam 10%
Octagam 5% and Octagam 10%, while under Octagam 10%
OG004
Octagam 10% and Panzyga, While Under Octagam 10%
Octagam 10% and Panzyga, while under Octagam 10%
OG005
Octagam 10% and Panzyga, While Under Panzyga
Octagam 10% and Panzyga, while under Panzyga
Units
Counts
Participants
OG000139
OG001183
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00017
OG00137
OG0020
OG003
Secondary
Infection Occurrence
Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections.
Number of patients in the safety population with the respective diagnosis who attended the respective visit. Not all patients attended respective visit.
Posted
Count of Participants
Participants
Up to one year
ID
Title
Description
OG000
Octagam 5%
Octagam 5%
OG001
Octagam 10%
Octagam 10%
OG002
Octagam 5% and Octagam 10%
Panzyga
OG003
Octagam 10% and Panzyga
Octagam 10% and Panzyga
Units
Time Frame
Approximately 12 months, observational study
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Octagam 5%
Octagam 5%
1
139
3
139
13
139
EG001
Octagam 10%
Octagam 10%
0
183
1
183
37
183
EG002
Octagam 5% and Octagam 10%, While Under Octagam 5%
Octagam 5% and Octagam 10%, while under Octagam 5%
0
11
0
11
0
11
EG003
Octagam 5% and Octagam 10%, While Under Octagam 10%
Octagam 5% and Octagam 10%, while under Octagam 10%