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Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (explorer8)

Primary Purpose

Haemophilia A Without Inhibitors, Haemophilia B Without 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 Without Inhibitors

Eligibility Criteria

12 Years - 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 severe haemophilia A (FVIII below 1%) or B (FIX equal to or below 2%).

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.
Presence of confirmed inhibitors 0.6 BU or greater at screening.
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 (PPX)

Arm 2: Concizumab prophylaxis

Arm 3: Concizumab prophylaxis

Arm 4: Concizumab prophylaxis

Arm Description

Haemophilia A (HA) and haemophilia B (HB) patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis. In the extension phase, this group will receive treatment with concizumab.

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

The HA patients enrolled into the concizumab phase 2 trial NN7415-4255 (explorer 5) will be offered enrolment into this arm.

Arm 4 will include patients previously on prophylaxis with factor products with a minimum of 24 weeks observation in NN7415-4322 (explorer 6) (at least 30 HA and 30 HB patients). In addition, arm 4 will also include: 1) Patients who were randomised to arms 1 and 2 before the treatment pause. 2) HA patients who were in NN7415-4255 (explorer 5) at the time of the treatment pause, and who have now completed explorer 5. 3) On demand patients included after arms 1 and 2 are closed.

Outcomes

Primary Outcome Measures

For haemophilia A patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes

This will be presented as 'count of episodes'.

For haemophilia B patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes

This will be presented as 'count of episodes'.

Secondary Outcome Measures

For haemophilia A patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes

This will be presented as 'count of episodes'. Arm 4 patients who have been on stable PPX at least 24 weeks in study 4322. For previous PPX (study 4322): From the point in time where PPX is stable and up until the end of study. Stable is defined as the time after an initial period on PPX treatment of at least 24 weeks. For concizumab PPX (trial 4307): From the point in time where the concizumab maintenance dose is confirmed, increased or decreased and up until the confirmatory analyses cut-off (at least 24 weeks).

For haemophilia B patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes

For haemophilia A patients without inhibitors: Number of treated spontaneous bleeding episodes

This will be presented as 'count of episodes'.

For haemophilia B patients without inhibitors: Number of treated spontaneous bleeding episodes

This will be presented as 'count of episodes'.

For haemophilia A patients without inhibitors: Number of treated spontaneous and traumatic joint bleeds

This will be presented as 'count of episodes'.

For haemophilia B patients without inhibitors: Number of treated spontaneous and traumatic joint bleeds

This will be presented as 'count of episodes'.

For haemophilia A patients without inhibitors: Number of treated spontaneous and traumatic target joint bleeds

This will be presented as 'count of episodes'.

For haemophilia B patients without inhibitors: 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 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 confirmatory analyses cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of concizumab treatment (week 25) up until the confirmatory analysis cut-off. Week 0 before the pause is defined as the time of the initial randomisation to on-demand administration or time of start of the previous concizumab dosing regimen (0.25 mg/kg/day). Week 0 after the pause is defined as the time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.

Number of thromboembolic events

This will be presented as 'count of events'. Week 0 before the pause is defined as the time of the initial randomisation to on-demand administration or time of start of the previous 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 confirmatory analyses cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of concizumab treatment (week 25) up until the confirmatory analysis cut-off. Week 0 before the pause is defined as the time of the initial randomisation to on-demand administration or time of start of the previous concizumab dosing regimen (0.25 mg/kg/day). Week 0 after the pause is defined as the time of randomisation to on-demand administration after the pause 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 the initial randomisation to on-demand administration or time of start of the previous 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 confirmatory analyses cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of concizumab treatment (week 25) up until the confirmatory analysis cut-off. Week 0 before the pause is defined as the time of the initial randomisation to on-demand administration or time of start of the previous concizumab dosing regimen (0.25 mg/kg/day). Week 0 after the pause is defined as the time of randomisation to on-demand administration after the pause 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 the initial randomisation to on-demand administration or time of start of the previous concizumab dosing regimen (0.25 mg/kg/day).

Number of patients with antibodies to concizumab

This will be presented as 'count of participants'. 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 confirmatory analyses cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of concizumab treatment (week 25) up until the confirmatory analysis cut-off. Week 0 before the pause is defined as the time of the initial randomisation to on-demand administration or time of start of the previous concizumab dosing regimen (0.25 mg/kg/day). Week 0 after the pause is defined as the time of randomisation to on-demand administration after the pause or time of start of the new concizumab dosing regimen.

Number of patients with antibodies to concizumab

This will be presented as 'count of participants'. Week 0 before the pause is defined as the time of the initial randomisation to on-demand administration or time of start of the previous 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

NCT04082429

First Posted

September 5, 2019

Last Updated

October 11, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04082429

Brief Title

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

Acronym

explorer8

Official Title

Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 13, 2019 (Actual)

Primary Completion Date

July 12, 2022 (Actual)

Study Completion Date

June 9, 2026 (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 without 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 have to inject themselves with the study medicine 1 time every day under the skin. This 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 up to 6.5 years. The length of time the participant will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (21 April 2026 at the latest). Participants will have to come to the clinic for up to 40 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. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in 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 Without Inhibitors, Haemophilia B Without Inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomised to concizumab PPX/no PPX/ assigned into non-randomised arms, based on treatment before trial. Upon restart, patients randomised to arms 1/2 before pause will enter arm 4. Patients allocated to arms 3 & 4 before pause will re-enter initially allocated arm. Randomisation into arms 1/2 will be restarted with new patients. Main part is completed when patient completed 24 wks (excluding screening) in arm 1 or 32 wks (excluding screening) in arms 2-4. After main part, patients will have offer to continue in extension (ext.) part and receive treatment with product until concizumab is commercially available in their countries or until 21-Apr-26 at latest. Patients will be in ext. part for up to 257 (arms 2-4) or 265 wks (arm 1) for up to additional 128 (arms 2-4) or 136 wks (arm 1). Patient will receive last dose at home on day prior to visit 26a. Follow-up part will start on visit 26a and lasts for 7 wks and include reporting of bleeding episodes until visit 27a.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: No prophylaxis (PPX)

Arm Type

Experimental

Arm Description

Arm Title

Arm 2: Concizumab prophylaxis

Arm Type

Experimental

Arm Description

HA and HB 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

The HA patients enrolled into the concizumab phase 2 trial NN7415-4255 (explorer 5) will be offered enrolment into this arm.

Arm Title

Arm 4: Concizumab prophylaxis

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Concizumab

Intervention Description

When patients are randomised/allocated to concizumab prophylaxis, they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week (Wk) 0) (arm 2, 3 and 4) or visit 9a (Wk 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 (Wk 6) or 9a.3 (Wk 30) and will be based on the concizumab exposure level measured at the previous visit 4a (Wk 6) or 9a.2 (Wk 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 replacement therapy until visit 9a (week 24; end of main part). In the extension part, patients in arm 1 will receive daily concizumab subcutaneous injections.

Primary Outcome Measure Information:

Title

For haemophilia A patients without inhibitors: 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 after the pause (Wk 0) up until start of concizumab treatment (Wk 24). Concizumab (arm 2): From start of the new concizumab dosing regimen (Wk 0) up until the confirmatory analyses cut-off (at least 32 weeks)

Title

For haemophilia B patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes

Description

This will be presented as 'count of episodes'.

Time Frame

Secondary Outcome Measure Information:

Title

For haemophilia A patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes

Description

Time Frame

Time frame is presented under 'outcome measure description'

Title

For haemophilia B patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes

Description

Time Frame

Time frame is presented under 'outcome measure description'

Title

For haemophilia A patients without inhibitors: Number of treated spontaneous bleeding episodes

Description

This will be presented as 'count of episodes'.

Time Frame

Title

For haemophilia B patients without inhibitors: Number of treated spontaneous bleeding episodes

Description

This will be presented as 'count of episodes'.

Time Frame

Title

For haemophilia A patients without inhibitors: Number of treated spontaneous and traumatic joint bleeds

Description

This will be presented as 'count of episodes'.

Time Frame

Title

For haemophilia B patients without inhibitors: Number of treated spontaneous and traumatic joint bleeds

Description

This will be presented as 'count of episodes'.

Time Frame

Title

For haemophilia A patients without inhibitors: Number of treated spontaneous and traumatic target joint bleeds

Description

This will be presented as 'count of episodes'.

Time Frame

Title

For haemophilia B patients without inhibitors: 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

Time frame 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 296 weeks).

Title

Number of hypersensitivity type reactions

Description

Time Frame

Time frame is presented under 'outcome measure description'.

Title

Number of hypersensitivity type reactions

Description

Time Frame

Title

Number of injection site reactions

Description

Time Frame

Time frame 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

Time frame 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

Minimum Age & Unit of Time

12 Years

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 severe haemophilia A (FVIII below 1%) or B (FIX equal to or below 2%). 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. Presence of confirmed inhibitors 0.6 BU or greater at screening. 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

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

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

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

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

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

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

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

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

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

København

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Brest

ZIP/Postal Code

29609

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Le Kremlin Bicetre

ZIP/Postal Code

94270

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

H-1134

Country

Hungary

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

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302004

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Tel-Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hyogo

ZIP/Postal Code

654-0047

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka

ZIP/Postal Code

546-0006

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Saitama

ZIP/Postal Code

330-8777

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Saitama

ZIP/Postal Code

350-0495

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shizuoka

ZIP/Postal Code

420-8660

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

157-8535

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

Jeju-do

ZIP/Postal Code

63241

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

Vilnius

ZIP/Postal Code

08406

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Ampang, Selangor

ZIP/Postal Code

68000

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

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

Poznań

State/Province

Wielkopolskie

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-081

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

Belgrade

ZIP/Postal Code

11070

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

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

Polokwane

State/Province

Limpopo

ZIP/Postal Code

0699

Country

South Africa

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

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valencia

ZIP/Postal Code

46026

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

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Ankara

State/Province

Beşevler/Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Capa-ISTANBUL

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Samsun

ZIP/Postal Code

55139

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

Belfast

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

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 Without Inhibitors

We'll reach out to this number within 24 hrs

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (explorer8)

Haemophilia A Without Inhibitors, Haemophilia B Without 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