NCT02303093

Brief Summary

Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
5 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

8.9 years

First QC Date

November 20, 2014

Results QC Date

June 5, 2021

Last Update Submit

June 5, 2021

Conditions

Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

Outcome Measures

Primary Outcomes (1)

  • Adverse Drug Reactions

    Number of patients with adverse drug reactions

    up to one year

Secondary Outcomes (1)

  • Infection Occurrence

    Up to one year

Study Arms (2)

Octagam

Patient receiving Octagam 5% or 10% IVIG

Biological: Octagam IVIG 5% or 10%

Panzyga

Patient receiving panzyga

Biological: Panzyga

Interventions

Octagam IVIG 5% or 10%BIOLOGICAL

Octagam IVIG 5% or 10%

Octagam
PanzygaBIOLOGICAL

Panzyga

Panzyga

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Octapharma Research Site

Gmunden, 17 4810, Austria

Location

Octapharma Research Site

Graz, 22 8036, Austria

Location

Octapharma Research Site

Klagenfurt, 35 9020, Austria

Location

Octapharma Research Site

Oberndorf, 56 5110, Austria

Location

Octapharma Research Site

Salzburg, 5020, Austria

Location

Octapharma Research Site

Vienna, 1090, Austria

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8N3Z5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Octapharma Research Site

Argenteuil, 95107, France

Location

Octapharma Research Site

Béziers, 34525, France

Location

Octapharma Research Site

Bourges, 18020, France

Location

Octapharma Research Location

Caen, 14033, France

Location

Octapharma Research Site

Caen, 14033, France

Location

Octapharma Research Site

La Rochelle, 17019, France

Location

Octapharma Research Site

Marseille, 13285, France

Location

Octapharma Research Location

Marseille, 13385, France

Location

Octapharma Research Site

Marseille, 13385, France

Location

Octapharma Research Center

Marseille, 13825, France

Location

Octapharma Research Site

Montauban, 82013, France

Location

Octapharma Research Site

Nantes, 44093, France

Location

Octapharma Research Site

Nevers, 58033, France

Location

Octapharma Research Site

Pessac, 33064, France

Location

Octapharma Research Site

Pierre-Bénite, 69310, France

Location

Octapharma Research Site

Rennes, 35033, France

Location

Octapharma Research Site

Toulouse, 31300, France

Location

Octapharma Research Site

Barcelona, 08035, Spain

Location

Octapharma Research Site

Madrid, 28040, Spain

Location

Octapharma Research Location

Madrid, 28041, Spain

Location

Octapharma Research Site

Madrid, 28041, Spain

Location

Octapharma Research Site

Madrid, 28046, Spain

Location

Octapharma Research Site

Leeds, LS97TF, United Kingdom

Location

Octapharma Research Site

London, E1 1BB, United Kingdom

Location

Octapharma Research Site

London, NW33QG, United Kingdom

Location

Octapharma Research Site

Plymouth, PL68DH, United Kingdom

Location

Octapharma Research Site

Stafford, ST16 3SA, United Kingdom

Location

MeSH Terms

Interventions

Panzyga

Results Point of Contact

Title
Dr. Bernhard Rohrbacher
Organization
Octapharma Pharmazeutika Produktionsgesm.b.H.,
bernhard.rohrbacher@octapharma.com
+431610324182

Study Officials

  • Lidia Cosentino

    Octapharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 27, 2014

Study Start

August 1, 2011

Primary Completion

June 5, 2020

Study Completion

June 5, 2020

Last Updated

June 29, 2021

Results First Posted

June 29, 2021

Record last verified: 2021-06

Locations

GB(5)CA(5)AU(6)FR(17)ES(5)