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A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Primary Purpose

Haemophilia A, Haemophilia A With Inhibitors

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

NNC0365-3769 (Mim8)

About this trial

This is an interventional treatment trial for Haemophilia A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records.
Participant has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening.
Age above or equal to 12 years at the time of signing informed consent.
Body weight greater than or equal to 30 kg.
Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
Applicable to participants with FVIII activity ≥1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires.

Exclusion Criteria:

Previous participation in this study. Participation is defined as signed informed consent.
Participation (i.e., signed informed consent) in any interventional clinical study with receipt of the last dose within 6 months (or 5 half-lives of the investigational medicinal product, whichever is shorter) before planned randomisation.
Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before planned randomisation, for participants not included in the run-in.
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period.
Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products.
Receipt of gene therapy at any given time point.
Ongoing or planned immune tolerance induction (ITI) therapy.
Major surgery planned to take place after screening.
Known congenital or acquired coagulation disorders other than haemophilia A.
Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above1.5 times the upper limit measured at screening.
Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening.
Previous or current thromboembolic disease or events (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator.
Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

no PPX- no PPX - Mim8 PPXQW/QM

no PPX - Mim8 PPXQW - Mim8 PPXQW

no PPX - Mim8 PPXQM - Mim8 PPXQM

PPX - Mim8 PPXQW

PPX- Mim8 PPXQM

Arm Description

Participants not receiving prophylaxis will not enter the run-in period. In arm 1, participants will be randomised to continue no prophylaxis (on-demand treatment with their Standard of Care products) or Mim8 once-weekly or once-monthly prophylaxis in agreement with investigators in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) in agreement with the investigator, either weekly or monthly Mim8 prophylaxis regimen.

Participants not receiving prophylaxis will not enter the run-in period. In arm 2a, participants will be randomised to Mim8 once-weekly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.

Participants not receiving prophylaxis will not enter the run-in period. In arm 2b, participants will be randomised to Mim8 once-monthly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthy Mim8 prophylaxis regimen.

Participants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 3, participants will be randomised to once-weekly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.

Participants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 4, participants will be randomised to once-monthly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthly Mim8 prophylaxis regimen.

Outcomes

Primary Outcome Measures

Number of treated bleeds

Count

Number of treated bleeds

Count

Secondary Outcome Measures

Number of injection site reactions

Count

Occurrence of anti-Mim8 antibodies

Count

Number of treated spontaneous bleeds

Count

Number of treated joint bleeds

Count

Number of treated traumatic bleeds

Count

Number of target joint bleeds

Count

Consumption of factor product per bleed treatment (number of injections)

Count

Change in physical function domain of PEDS-QL (pediatric quality of life inventory)

Score points Minimum score per question (best) = 0 Maximum score per question (worst) = 4 Total score for 13 questions: 0 (best) to 92 (worst)

Change in patient's treatment burden using the Hemo-TEM (haemophilia treatment experience measure)

Score points Ranges from 0 (best) - 4 (worst) representing answers ranging: 'Not at all difficult' - 'Extremely difficult' 'Never' - 'always' 'Not at all bothered' - 'Extremely bothered' 'Not at all interfering' - 'Extremely interfering' 'Not at all burdened' - 'Extremely burdened'

Change in patient's joint pain score using Joint Pain Rating Scale

Score points ranges from 0 = 'not at all' (best) to 4 = 'extremely' (worst)

Full Information

NCT ID

NCT05053139

First Posted

September 13, 2021

Last Updated

September 23, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT05053139

Brief Title

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Official Title

A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 2, 2021 (Actual)

Primary Completion Date

March 11, 2024 (Anticipated)

Study Completion Date

February 7, 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 is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

6. Conditions and Keywords

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

Haemophilia A, Haemophilia A With Inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

267 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

no PPX- no PPX - Mim8 PPXQW/QM

Arm Type

Experimental

Arm Description

Arm Title

no PPX - Mim8 PPXQW - Mim8 PPXQW

Arm Type

Experimental

Arm Description

Arm Title

no PPX - Mim8 PPXQM - Mim8 PPXQM

Arm Type

Experimental

Arm Description

Arm Title

PPX - Mim8 PPXQW

Arm Type

Experimental

Arm Description

Arm Title

PPX- Mim8 PPXQM

Arm Type

Experimental

Arm Description

Participants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 4, participants will be randomised to once-monthly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthly Mim8 prophylaxis regimen.

Intervention Type

Drug

Intervention Name(s)

NNC0365-3769 (Mim8)

Intervention Description

Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

Primary Outcome Measure Information:

Title

Number of treated bleeds

Description

Count

Time Frame

No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (week 26)

Title

Number of treated bleeds

Description

Count

Time Frame

Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to end of main (week 26)

Secondary Outcome Measure Information:

Title

Number of injection site reactions

Description

Count

Time Frame

All participants receiving Mim8 (Arms 2a, 2b, 3 and 4): From randomisation (week 0) to end of main (week 26)

Title

Occurrence of anti-Mim8 antibodies

Description

Count

Time Frame

All participants receiving Mim8 (Arms 2a, 2b, 3 and 4): From randomisation (week 0) to end of extension (week 52)

Title

Number of treated spontaneous bleeds

Description

Count

Time Frame

No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

Title

Number of treated joint bleeds

Description

Count

Time Frame

Title

Number of treated traumatic bleeds

Description

Count

Time Frame

Title

Number of target joint bleeds

Description

Count

Time Frame

Title

Consumption of factor product per bleed treatment (number of injections)

Description

Count

Time Frame

Title

Change in physical function domain of PEDS-QL (pediatric quality of life inventory)

Description

Score points Minimum score per question (best) = 0 Maximum score per question (worst) = 4 Total score for 13 questions: 0 (best) to 92 (worst)

Time Frame

All participants (Arms 1, 2a, 2b, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)

Title

Change in patient's treatment burden using the Hemo-TEM (haemophilia treatment experience measure)

Description

Time Frame

All participants (Arms 1, 2a, 2b, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)

Title

Change in patient's joint pain score using Joint Pain Rating Scale

Description

Score points ranges from 0 = 'not at all' (best) to 4 = 'extremely' (worst)

Time Frame

All participants (Arms 1, 2a, 2b, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records. Participant has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening. Age above or equal to 12 years at the time of signing informed consent. Body weight greater than or equal to 30 kg. Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed. Applicable to participants with FVIII activity ≥1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed. Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires. Exclusion Criteria: Previous participation in this study. Participation is defined as signed informed consent. Participation (i.e., signed informed consent) in any interventional clinical study with receipt of the last dose within 6 months (or 5 half-lives of the investigational medicinal product, whichever is shorter) before planned randomisation. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before planned randomisation, for participants not included in the run-in. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period. Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products. Receipt of gene therapy at any given time point. Ongoing or planned immune tolerance induction (ITI) therapy. Major surgery planned to take place after screening. Known congenital or acquired coagulation disorders other than haemophilia A. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above1.5 times the upper limit measured at screening. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening. Previous or current thromboembolic disease or events (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation. Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novo Nordisk

Phone

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Transparency (dept. 2834)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016-7710

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90007

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31404

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118-5720

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89135

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-2360

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19134

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Innsbruck

ZIP/Postal Code

A 6020

Country

Austria

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100045

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Ji'Nan

State/Province

Shandong

ZIP/Postal Code

250000

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Ji'Nan

State/Province

Shandong

ZIP/Postal Code

250000

Country

China

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610074

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650101

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Praha 2

ZIP/Postal Code

12000

Country

Czechia

Individual Site Status

Suspended

Facility Name

Novo Nordisk Investigational Site

City

København Ø

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bron Cedex

ZIP/Postal Code

69500

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Le Kremlin Bicetre Cedex

ZIP/Postal Code

94275

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75015

Country

France

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Rennes

ZIP/Postal Code

35033

Country

France

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

10249

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Mörfelden-Walldorf

ZIP/Postal Code

64546

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Surat

State/Province

Gujarat

ZIP/Postal Code

395002

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400012

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141008

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632004

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Noida

State/Province

Uttar Pradesh

ZIP/Postal Code

201303

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Dublin

State/Province

Leinster

ZIP/Postal Code

D08 A978

Country

Ireland

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

D12 N512

Country

Ireland

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Tel-Hashomer

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20089

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kitakyusyu-shi, Fukuoka

ZIP/Postal Code

807 8555

Country

Japan

Individual Site Status

Completed

Facility Name

Novo Nordisk Investigational Site

City

Okinawa

ZIP/Postal Code

901-1193

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Saitama

ZIP/Postal Code

330-8777

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

157-8535

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

167-0035

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Daejeon

ZIP/Postal Code

35233

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

05278

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV-1004

Country

Latvia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kaunas

ZIP/Postal Code

LT-50161

Country

Lithuania

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Vilnius

ZIP/Postal Code

08406

Country

Lithuania

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kota Kinabalu

State/Province

Sabah

ZIP/Postal Code

88586

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Selangor Darul Ehsan

ZIP/Postal Code

68000

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Merida

ZIP/Postal Code

97130

Country

Mexico

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50-556

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kraków

State/Province

Małopolskie

ZIP/Postal Code

30-688

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Coimbra

ZIP/Postal Code

3000-459

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200143

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200143

Country

Romania

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Timisoara

ZIP/Postal Code

300254

Country

Romania

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Krasnodar

ZIP/Postal Code

350007

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191186

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Riyadh

ZIP/Postal Code

12713

Country

Saudi Arabia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Rimavska Sobota

ZIP/Postal Code

979 12

Country

Slovakia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Vranov nad Toplou

ZIP/Postal Code

09327

Country

Slovakia

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Parktown, Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Parktown, Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Málaga

ZIP/Postal Code

29009

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

St. Gallen

ZIP/Postal Code

9008

Country

Switzerland

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Taichung City

ZIP/Postal Code

402

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Taichung City

ZIP/Postal Code

407

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Suspended

Facility Name

Novo Nordisk Investigational Site

City

Ankara

State/Province

Beşevler/Ankara

ZIP/Postal Code

06500

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Antalya

ZIP/Postal Code

01010

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bornova-IZMIR

ZIP/Postal Code

35100

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Capa-ISTANBUL

ZIP/Postal Code

34093

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Individual Site Status

Active, not recruiting

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

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

We'll reach out to this number within 24 hrs

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Haemophilia A, Haemophilia A With Inhibitors

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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