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Compassionate Use of Concizumab if You Have Haemophilia
Sponsor: Novo Nordisk A/S
Summary
The compassionate use programme will give participants concizumab for free, even though it is not yet approved by health authorities. This is because participants need this medicine to treat their haemophilia properly. The programme will check that participants are safe and that the medicine works for them. The programme may last for years. Participants will take one injection under their skin every day. Participants will have 4-5 visits with the study doctor for the first half year. After that they will have 1 visit every half year. At all clinic visits participants will have blood samples taken. Participants will fill in a diary between the visits. A patient is considered to have completed the programme when any of the following criteria occurred first: 1) when the patient is included in a clinical trial with concizumab or 2) up to 6 months after concizumab is commercially available in the patient's country and approved for the patient (The time span of 6 months should provide ample time for the patient to obtain concizumab commercially) or 3) the sponsor decides to discontinue concizumab clinical development for the patient's population.
Official title: Concizumab Compassionate Use Programme for Patients With Congenital Haemophilia
Key Details
Gender
All
Age Range
Any - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Concizumab
Injected under the skin (subcutaneous, sc) once daily, individual dose adjustment.
Locations (25)
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
University of California San Francisco UCSF
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Augusta University
Augusta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Childrens Hospital of Chicago
Chicago, Illinois, United States
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States
Children's Hosp-New Orleans
New Orleans, Louisiana, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Southern Specialty Clinic
Flowood, Mississippi, United States
Louisiana Ctr for Adv Med-LCAM
Madison, Mississippi, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Children's Nebraska
Omaha, Nebraska, United States
ECU Sickle Cell Comp Clinic
Greenville, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
BI-LO Chrt Childn's Cancer Ctr
Greenville, South Carolina, United States
Cook Children's Hospital-Hematology-Oncology
Fort Worth, Texas, United States
Texas Children's Hospital_Houston
Houston, Texas, United States
Univ TX Hlth Sci Ctr Houston
Houston, Texas, United States
Virginia Cwealth Univ Richmond
Richmond, Virginia, United States
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, Bulgaria
Koagulationsmottagningen
Solna, Sweden