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A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4) (FRONTIER4)

Primary Purpose

Haemophilia A, Haemophilia A With Inhibitors

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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

1 Year - 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 with diagnosis of congenital haemophilia A based on medical records Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728 at the time of transfer. Participant should qualify either of the following criteria: Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or, Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728. Participant and/or participant's parent(s)/participant's Legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary. Exclusion Criteria: Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728. Previous participation in this study. Participation is defined as signed informed consent. Female who is pregnant, breast-feeding or intends to become pregnant. Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures or as required by local regulation or practice). Participation (i.e., signed informed consent) in any interventional, clinical study (except from study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) of an approved or non-approved investigational medicinal product. Any planned major surgery, during part 1 of the study. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational SiteRecruiting
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) once every two weeks (Q2W) with subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX once-weekly (QW), Q2W or once-monthly (QM) with s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved.

Participants entering from study NN7769-4514 or NN7769-4516. In part 1, participants will receive Mim8 PPX QW or QM with s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX QW, Q2W or QM with s.c. administration using DV3407 pen-injector.

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events
Measured as count of events.

Secondary Outcome Measures

Number of injection site reactions
Measured as count of reactions.
Occurrence of anti Mim8 antibodies
Measured as count of participants.
Number of treated bleeding episodes
Measured as count of bleeds.
Number of treated spontaneous bleeding episodes
Measured as count of bleeds.
Number of treated traumatic bleeding episodes
Measured as count of bleeds.
Number of treated joint bleeding episodes
Measured as count of bleeds.
Number of treated target joint bleeding episodes (arm 2)
Measured as count of bleeds.
Mim8 plasma concentration
Measured as micrograms per milliliter (µg/mL).
Device handling using haemophilia device assessment tool (HDAT) (applicable for participants in arm 2 only)
Measured as percentage of participants.

Full Information

First Posted
January 4, 2023
Last Updated
October 11, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05685238
Brief Title
A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)
Acronym
FRONTIER4
Official Title
Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
April 28, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (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 looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often the participants will receive Mim8 in this study depends on the treatment participant receives in the current Mim8 study participant is taking part in. The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in 2028, whichever comes first. Mim8 will be injected under the skin with a thin needle either once a week, once every two weeks or once a month. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

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
Non-Randomized
Enrollment
425 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) once every two weeks (Q2W) with subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX once-weekly (QW), Q2W or once-monthly (QM) with s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Participants entering from study NN7769-4514 or NN7769-4516. In part 1, participants will receive Mim8 PPX QW or QM with s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX QW, Q2W or QM with s.c. administration using DV3407 pen-injector.
Intervention Type
Drug
Intervention Name(s)
Mim8
Intervention Description
Participants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 will use the DV3407 pen injector.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events
Description
Measured as count of events.
Time Frame
From visit 1 (week 0) until end of study (up to 283 weeks)
Secondary Outcome Measure Information:
Title
Number of injection site reactions
Description
Measured as count of reactions.
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Occurrence of anti Mim8 antibodies
Description
Measured as count of participants.
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Number of treated bleeding episodes
Description
Measured as count of bleeds.
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Number of treated spontaneous bleeding episodes
Description
Measured as count of bleeds.
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Number of treated traumatic bleeding episodes
Description
Measured as count of bleeds.
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Number of treated joint bleeding episodes
Description
Measured as count of bleeds.
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Number of treated target joint bleeding episodes (arm 2)
Description
Measured as count of bleeds.
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Mim8 plasma concentration
Description
Measured as micrograms per milliliter (µg/mL).
Time Frame
From visit 1 (week 0) until end of treatment (up to 262 weeks)
Title
Device handling using haemophilia device assessment tool (HDAT) (applicable for participants in arm 2 only)
Description
Measured as percentage of participants.
Time Frame
From visit 8 (week 26) until end of treatment (up to 262 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
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 with diagnosis of congenital haemophilia A based on medical records Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728 at the time of transfer. Participant should qualify either of the following criteria: Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or, Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728. Participant and/or participant's parent(s)/participant's Legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary. Exclusion Criteria: Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728. Previous participation in this study. Participation is defined as signed informed consent. Female who is pregnant, breast-feeding or intends to become pregnant. Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures or as required by local regulation or practice). Participation (i.e., signed informed consent) in any interventional, clinical study (except from study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) of an approved or non-approved investigational medicinal product. Any planned major surgery, during part 1 of the study. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
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
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Innsbruck
ZIP/Postal Code
A 6020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bron Cedex
ZIP/Postal Code
69500
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Le Kremlin Bicetre Cedex
ZIP/Postal Code
94275
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nantes cedex 1
ZIP/Postal Code
44093
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
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Mörfelden-Walldorf
ZIP/Postal Code
64546
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Noida
State/Province
Uttar Pradesh
ZIP/Postal Code
201303
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Dublin
State/Province
Leinster
ZIP/Postal Code
D08 A978
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Napoli
ZIP/Postal Code
80122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Saitama
ZIP/Postal Code
330-8777
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
167-0035
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
35233
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88586
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ampang, Selangor
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Merida
ZIP/Postal Code
97130
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-776
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Coimbra
ZIP/Postal Code
3000-459
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1169-045
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4050-651
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Poto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Not yet 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
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Vranov nad Toplou
ZIP/Postal Code
09327
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Individual Site Status
Not yet 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
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Esplugues Llobregat
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
St. Gallen
ZIP/Postal Code
9008
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Taichung City
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ankara
State/Province
Beşevler/Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06100
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
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bornova-IZMIR
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Capa-ISTANBUL
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Edirne
ZIP/Postal Code
22030
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
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Not yet 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 Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)

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