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Coagulation Factor

Nonacog Beta Pegol for Hemophilia B (paradigm™5 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 52 until the last patient has completed the trial (no later than 30-nov-2023)
Awards & highlights

paradigm™5 Trial Summary

This trial is conducted in Asia, Europe and North America to study a new drug for children with Haemophilia B.

Eligible Conditions
  • Hemophilia B
  • Congenital Hematological Disorder

paradigm™5 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 52 until the patient has completed the trial (no later than 30-nov-2023)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 52 until the patient has completed the trial (no later than 30-nov-2023) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)
Secondary outcome measures
Area Under the Curve Activity Versus Time Profile From Time Zero to 168 Hours Post Dose (AUC(0-168))
Clearance (CL)
Development of Host Cell Protein (HCP) Antibodies
+22 more

Side effects data

From 2022 Phase 3 trial • 54 Patients • NCT02141074
32%
Pyrexia
15%
Upper respiratory tract infection
15%
Nasopharyngitis
12%
Cough
9%
Rhinorrhoea
9%
Diarrhoea
9%
Ear infection
9%
Rash
9%
Viral infection
6%
Vomiting
6%
Factor IX inhibition
6%
Haemorrhage intracranial
6%
Otitis media
6%
Otitis media acute
3%
Skin laceration
3%
Anaphylactic reaction
3%
Pharyngitis
3%
Bronchitis
3%
Fall
3%
Influenza
3%
Conjunctivitis
3%
Drug hypersensitivity
3%
Tonsillitis
3%
Epistaxis
3%
Nasal congestion
3%
Teething
3%
Head injury
3%
Bronchiolitis
3%
Gastroenteritis salmonella
3%
Gastroenteritis viral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-prophylaxis
Prophylaxis

paradigm™5 Trial Design

1Treatment groups
Experimental Treatment
Group I: NNC-0156-000-0009Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nonacog beta pegol
2009
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,415,004 Total Patients Enrolled
54 Trials studying Hemophilia B
6,981 Patients Enrolled for Hemophilia B

Media Library

nonacog beta pegol (Coagulation Factor) Clinical Trial Eligibility Overview. Trial Name: NCT01467427 — Phase 3
Hemophilia B Research Study Groups: NNC-0156-000-0009
Hemophilia B Clinical Trial 2023: nonacog beta pegol Highlights & Side Effects. Trial Name: NCT01467427 — Phase 3
nonacog beta pegol (Coagulation Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01467427 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI
~2 spots leftby Apr 2025