Clinical trials: Factor IX Deficiency
Congenital Bleeding Disorder, Haemophilia A
Survey Evaluating the Psychosocial Effects of Living With Haemophilia
This study is conducted in Africa, Asia, Europe, North America and South America. The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Haemophilia A With Inhibitors
- Trial name
- HERO (NCT01322620)
- Testing
- No treatment given
- Where
- 3 sites in Canada, Spain and 1 more
- Volunteers
- 1,236 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia B
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
- Trial name
- paradigm™6 (NCT02141074)
- Testing
- nonacog beta pegol
- Where
- 93 sites in United States, Algeria and 22 more
- Volunteers
- 54 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia B
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.
- Trial name
- paradigm™ 4 (NCT01395810)
- Testing
- nonacog beta pegol
- Where
- 49 sites in United States, Austria and 16 more
- Volunteers
- 71 people
- Sponsor
- Novo Nordisk A/S
Hemophilia B
A Long-Term Follow-Up Study of Haemophilia B Patients Who Have Undergone Gene Therapy
Severe haemophilia B (HB) is a bleeding disorder where a protein made by the body to help make blood clot is either partly or completely missing.
- Trial name
- NCT03641703
- Testing
- FLT180a
- Where
- 6 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Spur Therapeutics
Haemophilia A, Haemophilia B
Impact of Conservative Treatment by Custom-made Orthoses in Patients With Haemophilic Ankle Arthropathy
The purpose of this study intend to evaluate the effectiveness of functional orthoses (including custom-made insoles and shoes) for preventing and controlling repetitive haemarthrosis in patients suffering of haemophilic ankle…
- Trial name
- NCT00638001
- Testing
- custom-molded insoles and custom-molded shoes
- Where
- Belgium
- Volunteers
- 70 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Congenital Bleeding Disorder, Haemophilia A
Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01272206
- Testing
- NNC 0128-0000-2011, NNC 0128-0000-2021
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Novo Nordisk A/S
Haemophilia B
A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B
The purpose of this study is: to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.
- Trial name
- NCT02263456
- Testing
- Replenine®-VF (High Purity Factor IX)
- Where
- 7 sites in United Kingdom
- Sponsor
- Bio Products Laboratory
Haemophilia B
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B
The study investigates how well the medicine called nonacog beta pegol (N9-GP) works in Chinese people with haemophilia B. Participants will be treated with N9-GP.
- Trial name
- Paradigm9 (NCT05365217)
- Testing
- Nonacog beta pegol
- Where
- 15 sites in China
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
Hemophilia B, Factor IX Deficiency
Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
OBJECTIVES: Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.
- Trial name
- NCT00004801
- Testing
- monoclonal factor IX replacement therapy
- Volunteers
- 3 people
- Sponsor
- National Center for Research Resources (NCRR)
Haemophilia B
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B…
- Trial name
- NCT02250573
- Testing
- Replenine®-VF (High Purity Factor IX)
- Where
- 5 sites in Poland, Romania and 1 more
- Sponsor
- Bio Products Laboratory
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT00571584
- Testing
- activated recombinant human factor VII
- Where
- 18 sites in France, Hungary and 5 more
- Volunteers
- 24 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A, Hemophilia B
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia…
- Conditions
- Hemophilia A, Hemophilia B, Vitamin D Deficiency
- Trial name
- NCT01090206
- Testing
- Vitamin D and calcium
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Virginia Commonwealth University
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Healthy
- Trial name
- NCT01563471
- Testing
- activated recombinant human factor VII
- Where
- France
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Liver Cirrhosis, Hemophilia
Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
The goal of this observational study is to learn about the changes in coagulation factor VIII and IX levels in patients undergoing liver transplantation to help guide future management of coagulation factor replacement in…
- Conditions
- Liver Cirrhosis, Hemophilia, Hemophilia A, Hemophilia B
- Trial name
- NCT06014320
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Stanford University
Congenital Bleeding Disorder, Haemophilia A
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Trial name
- Explorer 1 (NCT01228669)
- Testing
- NNC 0172-0000-2021
- Where
- 16 sites in Austria, Denmark and 9 more
- Volunteers
- 52 people
- Sponsor
- Novo Nordisk A/S
Haemophilia B
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients
To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.
- Trial name
- NCT02231944
- Testing
- Replenine®-VF (High Purity Factor IX)
- Where
- 7 sites in Poland, United Kingdom
- Sponsor
- Bio Products Laboratory
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- ONE (NCT00703911)
- Testing
- eptacog alfa (activated)
- Where
- 16 sites in Algeria, Austria and 14 more
- Volunteers
- 102 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Trial name
- NCT00951873
- Testing
- activated recombinant human factor VII, long acting
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- NCT01949792
- Testing
- eptacog alfa (activated)
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A, Hemophilia B
Study of Surgical Practices in Patients With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively.
- Trial name
- CHALE (NCT06158334)
- Testing
- Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures, Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Hospices Civils de Lyon