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Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (explorer7)

Primary Purpose

Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Concizumab

About this trial

This is an interventional treatment trial for Haemophilia A With Inhibitors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
Male aged 12 years or older at the time of signing informed consent.
Congenital Haemophilia A or B of any severity with documented history of inhibitor (equal to or above 0.6 Bethesda Units (BU).
Patient has been prescribed, or in need of, treatment with bypassing agents in the last 24 weeks prior to screening (for patients not previously enrolled in NN7415-4310 (explorer 4)).

Exclusion Criteria:

Known or suspected hypersensitivity to any constituent of the trial product or related products.
Known inherited or acquired coagulation disorder other than congenital haemophilia.
Ongoing or planned Immune Tolerance Induction treatment.
History of thromboembolic disease (includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion). Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events.)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm 1: No prophylaxis

Arm 2: Concizumab prophylaxis

Arm 3: Concizumab prophylaxis

Arm 4: Concizumab prophylaxis

Arm Description

Haemophilia A with inhibitors (HAwI) and haemophilia B with inhibitors (HBwI) patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis. In the extension part, patients in arm 1 will receive daily concizumab subcutaneous (s.c., under the skin) injections.

HAwI and HBwI patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis.

The HAwI and HBwI patients enrolled into the concizumab phase 2 trial (NN7415-4310) at time of transfer will be offered enrolment into this trial. It is required that these patients are on concizumab prophylaxis up until enrolment into the trial. These patients will continue concizumab prophylaxis.

Patients previously on prophylaxis with by-passing agents and on-demand patients who are screened at a timepoint where the required number of patients in arms 1 and 2 have been randomised. These patients will, if eligible, be enrolled into the trial and will initiate concizumab prophylaxis at visit 2a (week 0).

Outcomes

Primary Outcome Measures

The number of treated spontaneous and traumatic bleeding episodes

This will be presented as 'count of episodes'.

Secondary Outcome Measures

Change in 36 Item short form health survey version 2 (SF36v2) bodily pain

This will be presented as 'score on a scale'. The bodily pain subscale of the SF-36v2 questionnaire consists of 2 items. Subscale scores range from 0-100 and are transformed into population norm adjusted T-scores. A higher score indicates a better outcome on this subscale.

Change in SF36v2 physical functioning

This will be presented as 'score on a scale'. The physical function subscale of the SF-36v2 questionnaire consists of 1 item with 10 subitems. Subscale scores range from 0-100 and are transformed into population norm adjusted T-scores. A higher score indicates a better outcome on this subscale.

Number of treated spontaneous bleeding episodes

This will be presented as 'count of episodes'.

Number of treated spontaneous and traumatic joint bleeds

This will be presented as 'count of episodes'.

Number of treated spontaneous and traumatic target joint bleeds

This will be presented as 'count of episodes'.

Number of thromboembolic events

This will be presented as 'count of thromboembolic events'. On demand (arm 1 main part): From randomisation to on demand treatment up until start of concizumab treatment. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Number of thromboembolic events

This will be presented as 'count of thromboembolic events'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).

Number of hypersensitivity type reactions

This will be presented as 'count of hypersensitivity type reactions'. On demand (arm 1 main part): From randomisation to on demand treatment up until start of concizumab treatment. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Number of hypersensitivity type reactions

This will be presented as 'count of hypersensitivity type reactions'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).

Number of injection site reactions

This will be presented as 'count of injection site reactions'. On demand (arm 1 main part): From randomisation to on demand treatment up until start of concizumab treatment. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Number of injection site reactions

This will be presented as 'count of injection site reactions'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).

Number of patients with antibodies to concizumab

This will be presented as 'count of patients'. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Number of patients with antibodies to concizumab

This will be presented as 'count of patients'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).

Pre-dose (trough) concizumab plasma concentration (Ctrough)

This will be measured in 'ng/mL'.

Pre-dose thrombin peak

This will be measured in 'nmol/L'.

Pre-dose free tissue factor pathway inhibitor (TFPI) concentration

This will be measured in 'ng/mL'.

Maximum concizumab plasma concentration (Cmax)

This will be measured in 'ng/mL'.

Area under the concizumab plasma concentration-time curve (AUC)

This will be measured in 'ng*hr/mL'.

Full Information

NCT ID

NCT04083781

First Posted

September 6, 2019

Last Updated

September 26, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04083781

Brief Title

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

Acronym

explorer7

Official Title

Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 21, 2019 (Actual)

Primary Completion Date

December 27, 2021 (Actual)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about six years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (12 November 2025 at the latest). Participants will have to come to the clinic for up to 41 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomised to concizumab prophylaxis (ppx) or no ppx or assigned into non-randomised treatment arms, based on their treatment regimen before entering the trial. Main part of trial is completed when participant has completed at least 24 weeks of participation in arm 1 or 32 weeks in arms 2, 3 and 4. After main part, all participants will be offered to continue in extension part and receive treatment until concizumab is commercially available in their countries or until 12 Nov 2025 for up to 241 weeks (arms 1-4) or up to 265 weeks (randomised to arm 1 before the pause). After extension part, participant will enter safety follow-up part on visit 26a, which defines end-of-treatment. Participant will receive last dose of trial drug at home on day prior to visit 26a. On visit 26a, participants will either start up commercially available concizumab or revert to previous ppx schedule or on-demand regimen. Follow-up part will start on visit 26a and lasts for 7 weeks.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: No prophylaxis

Arm Type

Experimental

Arm Description

Arm Title

Arm 2: Concizumab prophylaxis

Arm Type

Experimental

Arm Description

HAwI and HBwI patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis.

Arm Title

Arm 3: Concizumab prophylaxis

Arm Type

Experimental

Arm Description

Arm Title

Arm 4: Concizumab prophylaxis

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Concizumab

Intervention Description

Concizumab will be administered daily subcutaneously (s.c., under the skin). When patients are randomised to concizumab prophylaxis they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week 0: arm 2, 3 & 4) or visit 9a (week 24: arm 1) followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week dose adjustment period on 0.20 mg/kg concizumab, the patients can be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab. A potential dose adjustment will take place at visit 4a.1 (week 6: arm 2, 3 & 4) or 9a.3 (week 30: arm 1) and will be based on the concizumab exposure level measured at the previous visit 4a (week 4) or 9a.2 (week 28). Patients who have concizumab exposure levels of 200-4000 ng/mL will stay at 0.20 mg/kg concizumab. Patients in arm 1 will continue on-demand treatment with their usual bypassing product until visit 9a (week 24: end of main part for arm 1).

Primary Outcome Measure Information:

Title

The number of treated spontaneous and traumatic bleeding episodes

Description

This will be presented as 'count of episodes'.

Time Frame

On demand (arm 1): From randomisation (week 0) up until start of concizumab treatment (at least 24 weeks). Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)

Secondary Outcome Measure Information:

Title

Change in 36 Item short form health survey version 2 (SF36v2) bodily pain

Description

Time Frame

From start of treatment (week 0) until week 24. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Title

Change in SF36v2 physical functioning

Description

Time Frame

From start of treatment (week 0) until week 24. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Title

Number of treated spontaneous bleeding episodes

Description

This will be presented as 'count of episodes'.

Time Frame

On demand (arm 1): From randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)

Title

Number of treated spontaneous and traumatic joint bleeds

Description

This will be presented as 'count of episodes'.

Time Frame

Title

Number of treated spontaneous and traumatic target joint bleeds

Description

This will be presented as 'count of episodes'.

Time Frame

Title

Number of thromboembolic events

Description

Time Frame

Timeframe is presented under 'outcome measure description'

Title

Number of thromboembolic events

Description

Time Frame

Concizumab: Before the pause: From start of treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment up until the end of trial (up to 280 weeks).

Title

Number of hypersensitivity type reactions

Description

Time Frame

Timeframe is presented under 'outcome measure description'

Title

Number of hypersensitivity type reactions

Description

Time Frame

Title

Number of injection site reactions

Description

Time Frame

Timeframe is presented under 'outcome measure description'

Title

Number of injection site reactions

Description

Time Frame

Title

Number of patients with antibodies to concizumab

Description

Time Frame

Timeframe is presented under 'outcome measure description'

Title

Number of patients with antibodies to concizumab

Description

Time Frame

Title

Pre-dose (trough) concizumab plasma concentration (Ctrough)

Description

This will be measured in 'ng/mL'.

Time Frame

Prior to the concizumab administration at week 24 (after restart)

Title

Pre-dose thrombin peak

Description

This will be measured in 'nmol/L'.

Time Frame

Prior to the concizumab administration at week 24 (after restart)

Title

Pre-dose free tissue factor pathway inhibitor (TFPI) concentration

Description

This will be measured in 'ng/mL'.

Time Frame

Prior to the concizumab administration at week 24 (after restart)

Title

Maximum concizumab plasma concentration (Cmax)

Description

This will be measured in 'ng/mL'.

Time Frame

From 0 to 24 hours where 0 is time of the concizumab dose at week 24 (after restart)

Title

Area under the concizumab plasma concentration-time curve (AUC)

Description

This will be measured in 'ng*hr/mL'.

Time Frame

From 0 to 24 hours where 0 is time of the concizumab dose at week 24 (after restart)

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male aged 12 years or older at the time of signing informed consent. Congenital Haemophilia A or B of any severity with documented history of inhibitor (equal to or above 0.6 Bethesda Units (BU). Patient has been prescribed, or in need of, treatment with bypassing agents in the last 24 weeks prior to screening (for patients not previously enrolled in NN7415-4310 (explorer 4)). Exclusion Criteria: Known or suspected hypersensitivity to any constituent of the trial product or related products. Known inherited or acquired coagulation disorder other than congenital haemophilia. Ongoing or planned Immune Tolerance Induction treatment. History of thromboembolic disease (includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion). Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Algiers

ZIP/Postal Code

16000

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Constantine

ZIP/Postal Code

25000

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Praha 2

ZIP/Postal Code

12000

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha

ZIP/Postal Code

150 18

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Bron Cedex

ZIP/Postal Code

69500

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Clermont-Ferrand

ZIP/Postal Code

63100

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Le Kremlin Bicetre Cedex

ZIP/Postal Code

94275

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560034

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Dehli

State/Province

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ranipet

State/Province

Tamil Nadu

ZIP/Postal Code

632 517

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Castelfranco Veneto

ZIP/Postal Code

31033

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20124

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kagoshima

ZIP/Postal Code

890-8760

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Nara

ZIP/Postal Code

634-8522

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Saitama

ZIP/Postal Code

350-0495

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

167-0035

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Daejeon

ZIP/Postal Code

35233

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Kota Kinabalu

State/Province

Sabah

ZIP/Postal Code

88586

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Ampang, Selangor

ZIP/Postal Code

68000

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Georgetown, Penang

ZIP/Postal Code

10450

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0027

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Kraków

State/Province

Małopolskie

ZIP/Postal Code

30-688

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Krasnodar

ZIP/Postal Code

350007

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191186

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Parktown, Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4013

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Polokwane

State/Province

Limpopo

ZIP/Postal Code

0699

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Solna

ZIP/Postal Code

171 64

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Ubon Ratchathani

ZIP/Postal Code

34000

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Antalya

ZIP/Postal Code

01010

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Capa-ISTANBUL

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

01135

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Lviv

ZIP/Postal Code

79044

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

WC1N 3HR

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

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Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (explorer7)

Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial