A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
Public ClinicalTrials.gov record NCT03528551. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.
Study identification
- NCT ID
- NCT03528551
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2018 (Actual)
- Primary completion
- Dec 3, 2020 (Actual)
- Completion
- Dec 3, 2020 (Actual)
- Last update posted
- Dec 22, 2022
2018 – 2020
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85016-7710 | — |
| Novo Nordisk Investigational Site | Long Beach | California | 90806 | — |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | — |
| Novo Nordisk Investigational Site | New Orleans | Louisiana | 70118-5720 | — |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21205 | — |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48201 | — |
| Novo Nordisk Investigational Site | East Lansing | Michigan | 48824 | — |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55404 | — |
| Novo Nordisk Investigational Site | New Hyde Park | New York | 11040 | — |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28204 | — |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45229 | — |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45404 | — |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239 | — |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| Novo Nordisk Investigational Site | Charleston | South Carolina | 29425 | — |
| Novo Nordisk Investigational Site | Nashville | Tennessee | 37232-9830 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | — |
| Novo Nordisk Investigational Site | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03528551, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03528551 live on ClinicalTrials.gov.