A Phase 3 interventional study of nonacog beta pegol in Congenital Bleeding Disorder and Haemophilia B, sponsored by Novo Nordisk A/S. Completed at 41 sites in 17 countries. Open to male participants aged 13 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 13 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
Drug: nonacog beta pegol
The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).
Also known as: NNC-0156-0000-0009
Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale: - Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure. 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. 4. Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
Time frame: At the day of surgery
Consumption of NNC-0156-0000-0009 (U/kg Body Weight)
Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.
Time frame: During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
Transfusion Requirements (Fulfilling Transfusion Criteria)
Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.
Time frame: during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
Haemoglobin Pre- and Post-surgery Start
The mean pre-surgery and post surgery haemoglobin level.
Time frame: 0, 1 hour, 24 hours.
Incidence of Adverse Events (AEs)
The number of adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.
Time frame: during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
Incidence of Serious Adverse Events (SAE)
The number of serious adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.
Time frame: During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
Incidence of Inhibitors Against FIX (Coagulation Factor Nine)
Number of patients with inhibitory antibodies
Time frame: During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13)
The study was conducted at 10 sites in 8 countries : Italy (1 site), Malaysia (1 site), Romania (1 site), South Africa (1 site), Taiwan (1 site), Turkey (1 SIte), UK (2 sites), US (2 sites).
| Milestone | Nonacog Beta Pegol |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale: - Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure. 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. 4. Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
| Haemostatic responses | Nonacog Beta Pegol |
|---|---|
| Excellent | 10 |
| Good | 3 |
| Moderate | 0 |
| Poor | 0 |
Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.
| U/Kg | Nonacog Beta Pegol |
|---|---|
| Consumption of NNC-0156-0000-0009 (U/kg Body Weight) | 328.2 ± 113.1 |
Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.
| mL | Nonacog Beta Pegol |
|---|---|
| During surgery | 275 ± 35.4 |
| Post surgery through day 6 | 266.7 ± 28.9 |
The mean pre-surgery and post surgery haemoglobin level.
| mmol/L | Nonacog Beta Pegol |
|---|---|
| prior to surgery | 8.98 ± 0.67 |
| 1 hour post-surgery | 8.37 ± 0.78 |
| 24 hours post surgery | 7.99 ± 1.13 |
The number of adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.
| events per patient year of exposure | Nonacog Beta Pegol |
|---|---|
| Incidence of Adverse Events (AEs) | 12.12 |
The number of serious adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.
| Events per patient year of exposure | Nonacog Beta Pegol |
|---|---|
| Incidence of Serious Adverse Events (SAE) | 0 |
Number of patients with inhibitory antibodies
| patients | Nonacog Beta Pegol |
|---|---|
| Incidence of Inhibitors Against FIX (Coagulation Factor Nine) | 0 |
Collected over AEs from screening visit (day 0) and until post treatment follow-up period. Patients not continuing in the extension trial attended a follow-up visit 4 weeks ± 2 weeks after the last dose of nonacog beta pegol.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nonacog Beta Pegol | — | 0/13 (0%) | 9/13 (69.2%) |
| Event | Nonacog Beta Pegol |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/13 |
| Conjunctival haemorrhageEye disorders | 1/13 |
| Epigastric discomfortGastrointestinal disorders | 1/13 |
| ExcoriationInjury, poisoning and procedural complications | 1/13 |
| Face oedemaGeneral disorders | 1/13 |
| FallInjury, poisoning and procedural complications | 1/13 |
| HaemorrhageVascular disorders | 1/13 |
| HypertensionVascular disorders | 1/13 |
| Musculoskeletal discomfortMusculoskeletal and connective tissue disorders | 1/13 |
| NauseaGastrointestinal disorders | 1/13 |
The full analysis set consists of all patients exposed to nonacog beta pegol.
| Age, Categorical(Participants) | Nonacog Beta Pegol |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Age, Continuous(years) | Nonacog Beta Pegol |
|---|---|
| Median | 39 ± 12.6 |
| Sex: Female, Male(Participants) | Nonacog Beta Pegol |
|---|---|
| Female | 0 |
| Male | 13 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S