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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)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  1. 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.
  2. Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records.
  3. Participant has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening.
  4. Age above or equal to 12 years at the time of signing informed consent.
  5. Body weight greater than or equal to 30 kg.
  6. 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.
  7. 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.
  8. Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires.

Exclusion Criteria:

  1. Previous participation in this study. Participation is defined as signed informed consent.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products.
  7. Receipt of gene therapy at any given time point.
  8. Ongoing or planned immune tolerance induction (ITI) therapy.
  9. Major surgery planned to take place after screening.
  10. Known congenital or acquired coagulation disorders other than haemophilia A.
  11. 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.
  12. 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.
  13. 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.
  14. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
  15. Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

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

First Posted
September 13, 2021
Last Updated
September 23, 2023
Sponsor
Novo Nordisk A/S
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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
No
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
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.
Arm Title
no PPX - Mim8 PPXQW - Mim8 PPXQW
Arm Type
Experimental
Arm Description
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.
Arm Title
no PPX - Mim8 PPXQM - Mim8 PPXQM
Arm Type
Experimental
Arm Description
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.
Arm Title
PPX - Mim8 PPXQW
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 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.
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
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 traumatic 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 target joint 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
Consumption of factor product per bleed treatment (number of injections)
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
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
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'
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
No
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
Email
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

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