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A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

NCT ID: NCT03196297

Last Updated: 2021-11-16

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2020-06-03

Brief Summary

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This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.

Detailed Description

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Conditions

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Haemostasis Haemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concizumab

Daily administration of concizumab to both on-demand and prophylaxis patients

Group Type EXPERIMENTAL

Concizumab

Intervention Type DRUG

0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase

Turoctocog alfa

Intervention Type DRUG

Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels

Interventions

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Concizumab

0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase

Intervention Type DRUG

Turoctocog alfa

Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Informed consent obtained before any trial-related activities.

Exclusion Criteria

Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia A (FVIII activity below 1%), based on medical records or results at screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia A - Presence of inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units) at screening measured by the Nijmegen method
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Los Angeles, California, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Novo Nordisk Investigational Site

Nashville, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Salt Lake City, Utah, United States

Site Status

Novo Nordisk Investigational Site

Brest, , France

Site Status

Novo Nordisk Investigational Site

Caen, , France

Site Status

Novo Nordisk Investigational Site

Nantes, , France

Site Status

Novo Nordisk Investigational Site

Bonn, , Germany

Site Status

Novo Nordisk Investigational Site

Homburg, , Germany

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Rome, , Italy

Site Status

Novo Nordisk Investigational Site

Aichi, , Japan

Site Status

Novo Nordisk Investigational Site

Nara, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Málaga, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Solna, , Sweden

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Bornova-IZMIR, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Edirne, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Lviv, , Ukraine

Site Status

Novo Nordisk Investigational Site

Belfast, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Cambridge, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Countries

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United States France Germany Italy Japan Spain Sweden Thailand Turkey (Türkiye) Ukraine United Kingdom

References

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Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J, Chowdary P. Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. Blood Adv. 2022 Jun 14;6(11):3422-3432. doi: 10.1182/bloodadvances.2021006403.

Reference Type DERIVED
PMID: 35290453 (View on PubMed)

Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.

Reference Type DERIVED
PMID: 31444162 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1179-3872

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000614-29

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-173682

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN7415-4255

Identifier Type: -

Identifier Source: org_study_id