Clincosm LogoSign in Get a demo

explorer™6: A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03741881
Collaborator
(none)
231
Enrollment
143
Locations
34.2
Actual Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.

Condition or Disease Intervention/Treatment Phase
  • Other: No treatment given

Study Design

Study Type:
Observational
Actual Enrollment :
231 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)
Actual Study Start Date :
Dec 18, 2018
Actual Primary Completion Date :
Oct 25, 2021
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients with haemophilia

Patients with haemophilia A or B and with or without inhibitors

Other: No treatment given
Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).

Outcome Measures

Primary Outcome Measures

  1. The number of treated bleeding episodes [From enrolment (week 0) and up to a maximum of 115 weeks]

    Count of treated bleeding episodes

Secondary Outcome Measures

  1. The number of all bleeding episodes [From enrolment (week 0) and up to a maximum of 115 weeks]

    Count of bleeding episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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 eligibility for the study.

  2. Male, age equal to or above 12 years at the time of signing informed consent.

  3. Patients with congenital haemophilia with inhibitors treated with FEIBA® prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1).

(For Turkey only: Patients with congenital haemophilia with inhibitors treated with by-passing agents prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1)).

  1. Severe (FVIII activity below 1%) congenital haemophilia A or severe/moderate (FIX activity equal to or below 2%) congenital haemophilia B, or congenital haemophilia A or B of any severity, with a presence or history of inhibitor (equal to or above 0.6 Bethesda Unit (BU)), based on medical records

  2. Patients with CHwI treated on-demand: equal to or above 6 treated (with bypassing agent) bleeding episodes within 24 weeks (or equal to or above 12 during 52 weeks) before screening (visit 1) and patients with severe congenital HA/HB treated on-demand: equal to or above 5 treated (with factor product) bleeding episodes within 24 weeks (or equal to or above 10 during 52 weeks) before screening (visit 1).

Exclusion Criteria:

  1. Known or suspected hypersensitivity to monoclonal antibodies.

  2. Previous participation in this study. Participation is defined as signed informed consent.

  3. Any disorder, except for conditions associated with congenital haemophilia, which in the physician's opinion might jeopardise patient's safety or compliance with the protocol.

  4. Previous treatment with concizumab. Previous treatment is defined as two or more doses administered.

  5. Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.

  6. Current or planned treatment with emicizumab.

  7. Any known congenital or acquired coagulation disorder other than congenital haemophilia.

  8. History of thromboembolic disease, current clinical signs of or treatment for thromboembolic disease, or at high risk of thromboembolic disease as judged by the investigator.

  9. Presence or history of malignant neoplasm within 5 years prior to the day of screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Los Angeles California United States 90027
2 Novo Nordisk Investigational Site Sacramento California United States 95817
3 Novo Nordisk Investigational Site Aurora Colorado United States 80045
4 Novo Nordisk Investigational Site Washington District of Columbia United States 20007
5 Novo Nordisk Investigational Site Atlanta Georgia United States 30322
6 Novo Nordisk Investigational Site Augusta Georgia United States 30912
7 Novo Nordisk Investigational Site Macon Georgia United States 31201
8 Novo Nordisk Investigational Site Chicago Illinois United States 60612
9 Novo Nordisk Investigational Site Indianapolis Indiana United States 46260
10 Novo Nordisk Investigational Site Detroit Michigan United States 48201
11 Novo Nordisk Investigational Site East Lansing Michigan United States 48823
12 Novo Nordisk Investigational Site Saint Louis Missouri United States 63110
13 Novo Nordisk Investigational Site Las Vegas Nevada United States 89135
14 Novo Nordisk Investigational Site Newark New Jersey United States 07102
15 Novo Nordisk Investigational Site Albuquerque New Mexico United States 87131
16 Novo Nordisk Investigational Site Charlotte North Carolina United States 28203
17 Novo Nordisk Investigational Site Charlotte North Carolina United States 28204
18 Novo Nordisk Investigational Site Cleveland Ohio United States 44106
19 Novo Nordisk Investigational Site Dayton Ohio United States 45404
20 Novo Nordisk Investigational Site Hershey Pennsylvania United States 17033
21 Novo Nordisk Investigational Site Philadelphia Pennsylvania United States 19104
22 Novo Nordisk Investigational Site Philadelphia Pennsylvania United States 19134
23 Novo Nordisk Investigational Site Charleston South Carolina United States 29425
24 Novo Nordisk Investigational Site Nashville Tennessee United States 37232-9830
25 Novo Nordisk Investigational Site Houston Texas United States 77030
26 Novo Nordisk Investigational Site San Antonio Texas United States 78229
27 Novo Nordisk Investigational Site Salt Lake City Utah United States 84113
28 Novo Nordisk Investigational Site Charlottesville Virginia United States 22908
29 Novo Nordisk Investigational Site Milwaukee Wisconsin United States 53226
30 Novo Nordisk Investigational Site Algiers Algeria 16000
31 Novo Nordisk Investigational Site Constantine Algeria 25000
32 Novo Nordisk Investigational Site Melbourne Victoria Australia 3004
33 Novo Nordisk Investigational Site Parkville Victoria Australia 3052
34 Novo Nordisk Investigational Site Murdoch Western Australia Australia 6150
35 Novo Nordisk Investigational Site Amstetten Austria A 3300
36 Novo Nordisk Investigational Site Banja Luka Bosnia and Herzegovina 78000
37 Novo Nordisk Investigational Site Plovdiv Bulgaria 4002
38 Novo Nordisk Investigational Site Sofia Bulgaria 1527
39 Novo Nordisk Investigational Site Varna Bulgaria 9010
40 Novo Nordisk Investigational Site Calgary Alberta Canada T2N 2T9
41 Novo Nordisk Investigational Site Saint John New Brunswick Canada E2L 4L4
42 Novo Nordisk Investigational Site St. John's Newfoundland and Labrador Canada A1B 3V6
43 Novo Nordisk Investigational Site Hamilton Ontario Canada L8N 3Z5
44 Novo Nordisk Investigational Site Hamilton Ontario Canada L8S 4K1
45 Novo Nordisk Investigational Site Zagreb Croatia 10 000
46 Novo Nordisk Investigational Site Zagreb Croatia 10000
47 Novo Nordisk Investigational Site Tallinn Estonia 13419
48 Novo Nordisk Investigational Site Helsinki Finland 00290
49 Novo Nordisk Investigational Site Brest France 29609
50 Novo Nordisk Investigational Site Bron Cedex France 69677
51 Novo Nordisk Investigational Site Caen France 14033
52 Novo Nordisk Investigational Site Kremlin-Bicêtre France 94270
53 Novo Nordisk Investigational Site Lille France 59037
54 Novo Nordisk Investigational Site Nantes Cedex 1 France 44093
55 Novo Nordisk Investigational Site Paris France 75015
56 Novo Nordisk Investigational Site Rennes France 35033
57 Novo Nordisk Investigational Site Saint Etienne France 42055
58 Novo Nordisk Investigational Site Bonn Germany 53127
59 Novo Nordisk Investigational Site Homburg Germany 66421
60 Novo Nordisk Investigational Site Athens Greece GR-11527
61 Novo Nordisk Investigational Site Thessaloniki Greece GR 54642
62 Novo Nordisk Investigational Site Budapest Hungary H-1134
63 Novo Nordisk Investigational Site Bangalore Karnataka India 560034
64 Novo Nordisk Investigational Site Pune Maharashtra India 411004
65 Novo Nordisk Investigational Site New Dehli New Delhi India 110029
66 Novo Nordisk Investigational Site Vellore Tamil Nadu India 632004
67 Novo Nordisk Investigational Site Kolkatta West Bengal India 70014
68 Novo Nordisk Investigational Site Tel-Hashomer Israel 52621
69 Novo Nordisk Investigational Site Castelfranco Veneto Italy 31033
70 Novo Nordisk Investigational Site Firenze Italy 50134
71 Novo Nordisk Investigational Site Roma Italy 00161
72 Novo Nordisk Investigational Site Udine Italy 33100
73 Novo Nordisk Investigational Site Verona Italy 37126
74 Novo Nordisk Investigational Site Aichi Japan 466-8560
75 Novo Nordisk Investigational Site Hiroshima Japan 734-8551
76 Novo Nordisk Investigational Site Hyogo Japan 654-0047
77 Novo Nordisk Investigational Site Kagoshima Japan 890-8760
78 Novo Nordisk Investigational Site Kanagawa Japan 216-8511
79 Novo Nordisk Investigational Site Kyoto Japan 602-8566
80 Novo Nordisk Investigational Site Mie Japan 514-8507
81 Novo Nordisk Investigational Site Nara Japan 634-8522
82 Novo Nordisk Investigational Site Niigata Japan 941-8502
83 Novo Nordisk Investigational Site Osaka Japan 546-0006
84 Novo Nordisk Investigational Site Saitama Japan 330-8777
85 Novo Nordisk Investigational Site Saitama Japan 350-0495
86 Novo Nordisk Investigational Site Shizuoka Japan 420-8660
87 Novo Nordisk Investigational Site Tokyo Japan 157-8535
88 Novo Nordisk Investigational Site Tokyo Japan 167-0035
89 Novo Nordisk Investigational Site Busan Korea, Republic of 49241
90 Novo Nordisk Investigational Site Daejeon Korea, Republic of 302-799
91 Novo Nordisk Investigational Site Daejeon Korea, Republic of 361-711
92 Novo Nordisk Investigational Site Jeju-do Korea, Republic of 63241
93 Novo Nordisk Investigational Site Seoul Korea, Republic of 03722
94 Novo Nordisk Investigational Site Seoul Korea, Republic of 05278
95 Novo Nordisk Investigational Site Vilnius Lithuania 08406
96 Novo Nordisk Investigational Site Vilnius Lithuania LT-08661
97 Novo Nordisk Investigational Site Selangor Darul Ehsan Malaysia 68000
98 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64460
99 Novo Nordisk Investigational Site Groningen Netherlands 9713 GZ
100 Novo Nordisk Investigational Site Oslo Norway 0027
101 Novo Nordisk Investigational Site Krakow Poland 31-501
102 Novo Nordisk Investigational Site Lublin Poland 20-081
103 Novo Nordisk Investigational Site Lublin Poland 20-093
104 Novo Nordisk Investigational Site Warszawa Poland 02-776
105 Novo Nordisk Investigational Site Porto Portugal 4200-319
106 Novo Nordisk Investigational Site Krasnodar Russian Federation 350007
107 Novo Nordisk Investigational Site Moscow Russian Federation 119049
108 Novo Nordisk Investigational Site Moscow Russian Federation 125167
109 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 191186
110 Novo Nordisk Investigational Site Belgrade Serbia 11000
111 Novo Nordisk Investigational Site Belgrade Serbia 11070
112 Novo Nordisk Investigational Site Kragujevac Serbia 34000
113 Novo Nordisk Investigational Site Novi Sad Serbia 21000
114 Novo Nordisk Investigational Site Bratislava Slovakia 851 07
115 Novo Nordisk Investigational Site Parktown, Johannesburg Gauteng South Africa 2193
116 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4013
117 Novo Nordisk Investigational Site Polokwane Limpopo South Africa 0699
118 Novo Nordisk Investigational Site Madrid Spain 28046
119 Novo Nordisk Investigational Site Málaga Spain 29010
120 Novo Nordisk Investigational Site Oviedo Spain 33011
121 Novo Nordisk Investigational Site Sevilla Spain 41013
122 Novo Nordisk Investigational Site Valencia Spain 46026
123 Novo Nordisk Investigational Site Malmö Sweden 205 02
124 Novo Nordisk Investigational Site Solna Sweden 171 64
125 Novo Nordisk Investigational Site Zürich Switzerland 8091
126 Novo Nordisk Investigational Site Adana Turkey 01130
127 Novo Nordisk Investigational Site Ankara Turkey 06230
128 Novo Nordisk Investigational Site Ankara Turkey 06500
129 Novo Nordisk Investigational Site Antalya Turkey 01010
130 Novo Nordisk Investigational Site Bornova-IZMIR Turkey 35100
131 Novo Nordisk Investigational Site Capa-ISTANBUL Turkey 35100
132 Novo Nordisk Investigational Site Edirne Turkey 22030
133 Novo Nordisk Investigational Site Istanbul Turkey 34098
134 Novo Nordisk Investigational Site Samsun Turkey
135 Novo Nordisk Investigational Site Kyiv Ukraine 01135
136 Novo Nordisk Investigational Site Lviv Ukraine 79044
137 Novo Nordisk Investigational Site Belfast United Kingdom BT9 7AB
138 Novo Nordisk Investigational Site Birmingham United Kingdom B15 2TH
139 Novo Nordisk Investigational Site London United Kingdom NW3 2QG
140 Novo Nordisk Investigational Site London United Kingdom WC1N 3HR
141 Novo Nordisk Investigational Site Manchester United Kingdom M13 9WL
142 Novo Nordisk Investigational Site Nottingham United Kingdom NG7 2UH
143 Novo Nordisk Investigational Site Sheffield United Kingdom S10 2JF

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03741881
Other Study ID Numbers:
  • NN7415-4322
  • U1111-1182-3359
First Posted:
Nov 15, 2018
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hemophilia A
Hemophilia B

Study Results

No Results Posted as of Nov 23, 2021