MedDataX Logo

A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A

NCT ID: NCT03528551

Last Updated: 2022-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2020-12-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Bleeding Disorder Haemophilia A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N8-GP, once weekly

All participants will receive turoctocog alfa pegol (N8-GP) once weekly.

Group Type EXPERIMENTAL

Turoctocog alfa pegol

Intervention Type DRUG

Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years.

N8-GP, twice weekly

All participants will receive N8-GP twice weekly.

Group Type EXPERIMENTAL

Turoctocog alfa pegol

Intervention Type DRUG

Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years.

N8-GP, three times weekly

All participants will receive N8-GP three times weekly.

Group Type EXPERIMENTAL

Turoctocog alfa pegol

Intervention Type DRUG

Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Turoctocog alfa pegol

Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years.

Intervention Type DRUG

Turoctocog alfa pegol

Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years.

Intervention Type DRUG

Turoctocog alfa pegol

Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male patients of all ages with the diagnosis of severe congenital haemophilia A (coagulation Factor VIII \[FVIII\] activity less than 1%) based on medical records
* On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of transfer

Exclusion Criteria

* Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
* Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved investigational medicinal product
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Reporting Anchor and Disclosure 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Long Beach, California, United States

Site Status

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Site Status

Novo Nordisk Investigational Site

New Orleans, Louisiana, United States

Site Status

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Detroit, Michigan, United States

Site Status

Novo Nordisk Investigational Site

East Lansing, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

New Hyde Park, New York, United States

Site Status

Novo Nordisk Investigational Site

Charlotte, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Cincinnati, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Dayton, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Portland, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Charleston, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

Nashville, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Norfolk, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Camperdown, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Parkville, Victoria, Australia

Site Status

Novo Nordisk Investigational Site

Campinas, São Paulo, Brazil

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Zagreb, , Croatia

Site Status

Novo Nordisk Investigational Site

Århus N, , Denmark

Site Status

Novo Nordisk Investigational Site

Bron, , France

Site Status

Novo Nordisk Investigational Site

Le Kremlin-Bicêtre, , France

Site Status

Novo Nordisk Investigational Site

Nantes, , France

Site Status

Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt/M., , Germany

Site Status

Novo Nordisk Investigational Site

Homburg, , Germany

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Debrecen, , Hungary

Site Status

Novo Nordisk Investigational Site

Tel Litwinsky, , Israel

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Vicenza, , Italy

Site Status

Novo Nordisk Investigational Site

Kitakyusyu-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Nara, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Vilnius, , Lithuania

Site Status

Novo Nordisk Investigational Site

Selangor Darul Ehsan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Groningen, , Netherlands

Site Status

Novo Nordisk Investigational Site

Rotterdam, , Netherlands

Site Status

Novo Nordisk Investigational Site

Oslo, , Norway

Site Status

Novo Nordisk Investigational Site

Porto, , Portugal

Site Status

Novo Nordisk Investigational Site

San Juan, , Puerto Rico

Site Status

Novo Nordisk Investigational Site

Daejeon, , South Korea

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Málaga, , Spain

Site Status

Novo Nordisk Investigational Site

Bellinzona, , Switzerland

Site Status

Novo Nordisk Investigational Site

Lausanne, , Switzerland

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Taipei, , Taiwan

Site Status

Novo Nordisk Investigational Site

Adana, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Antalya, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Bornova-IZMIR, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

İzmit, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Samsun, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Lviv, , Ukraine

Site Status

Novo Nordisk Investigational Site

Basingstoke, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Cardiff, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Oxford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Oxford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Brazil Canada Croatia Denmark France Germany Greece Hungary Israel Italy Japan Lithuania Malaysia Netherlands Norway Portugal Puerto Rico South Korea Spain Switzerland Taiwan Turkey (Türkiye) Ukraine United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1202-2780

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003788-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-183952

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN7088-4410

Identifier Type: -

Identifier Source: org_study_id