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Nonacog Beta Pegol for Hemophilia B (paradigm™5 Trial)
paradigm™5 Trial Summary
This trial is conducted in Asia, Europe and North America to study a new drug for children with Haemophilia B.
- Hemophilia B
- Congenital Hematological Disorder
paradigm™5 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 54 Patients • NCT02141074paradigm™5 Trial Design
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Who is running the clinical trial?
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- You have a blood clotting disorder that is not hemophilia B.You are taking medications that affect the immune system or are used to treat cancer, except for certain types of steroids.You have had a heart attack or stroke in the past.You have HIV and a low CD4+ lymphocyte count.Men with a serious type of inherited bleeding disorder called hemophilia B and have very low levels of Factor IX in their blood.You have used other FIX products for at least 50 days in the past.Your weight is 10 kilograms or more.You have a history of inhibitors to factor IX.You have a certain level of inhibitors in your blood that may affect the study.Your blood platelet count is lower than 50,000 per microliter at the initial check-up.Your ALT levels are more than three times the normal range during screening.Your creatinine level is higher than 1.5 times the normal range.
- Group 1: NNC-0156-000-0009
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people total are allowed to join this research project?
"The study is not presently recruiting patients for participation. The listing was first posted on May 16th, 2012 and last updated on November 8th, 2020. There are other active clinical trials that might be of interest; 112 trials for hemophilia b and 1 trial for nonacog beta pegol are both open for recruitment."
Does this research project allow participants who are over the age of 40?
"Following the study's inclusion criteria, patients that wish to participate must be between 0 and 12 years old."
What are some of the conditions that nonacog beta pegol has been effective in treating?
"Perioperative blood loss, hemorrhage, and bleeding can all be effectively treated using nonacog beta pegol."
Has nonacog beta pegol received approval from the FDA?
"There is clinical evidence to support the safety of nonacog beta pegol, thus it received a score of 3."
Is nonacog beta pegol a new medication being trialed?
"Novo Nordisk Investigational Site first began to study nonacog beta pegol in 2012 and, since then, 6 trials have completed. Presently, there is 1 active trial with a considerable amount of the research taking place in Nashville, Tennessee."
If I enroll, am I allowed to finish the whole clinical trial?
"This haemophilia B clinical trial, which is looking for 25 participants, has several notable inclusion criteria. Most importantly, patients must be between 0 and 12 years old (at the time of inclusion), have a history of exposure to other FIX products (with at least 50 exposure days), be able to assess their own bleeds and keep track of them in an electronic diary, as well as being willing/able to follow all other trial procedures. In addition, candidates must weigh more than 10 kg and be male patients with moderately severe or worse congenital haemophilia B whose Factor IX activity levels are below 2% according to medical"
Does this type of medical research exist?
"Nov Nordisk A/S sponsored the first clinical trial for nonacog beta pegol in 2012 and, to date, 6 trials have been completed. The most recent study is still ongoing across 20 cities and 11 countries. This Phase 3 drug approval stage study involves 25 participants."
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