NCT03741881|Completed

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

explorer™6

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)

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN7415-4322U1111-1182-3359

Study Type

observational

Target

231

Locations

33 countries

Sites

137

Timeline

RegisteredNov 2018

StartedDec 2018

CompletionOct 2021

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

231

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach

33 countries

137 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

November 13, 2018

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed

1 month until next milestone

Study Start

First participant enrolled

December 18, 2018

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed

Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

November 13, 2018

Last Update Submit

November 22, 2021

Conditions

Haemophilia A Haemophilia A With Inhibitors Haemophilia B Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (1)

The number of treated bleeding episodes
Count of treated bleeding episodes
From enrolment (week 0) and up to a maximum of 115 weeks

Secondary Outcomes (1)

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

Study Arms (1)

Patients with haemophilia

Patients with haemophilia A or B and with or without inhibitors

Other: No treatment given

Interventions

No treatment givenOTHER

Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).

Patients with haemophilia

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with haemophilia A or B and with or without inhibitors

You may qualify if:

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

You may not qualify if:

Known or suspected hypersensitivity to monoclonal antibodies.
Previous participation in this study. Participation is defined as signed informed consent.
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.
Previous treatment with concizumab. Previous treatment is defined as two or more doses administered.
Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.
Current or planned treatment with emicizumab.
Any known congenital or acquired coagulation disorder other than congenital haemophilia.
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.
Presence or history of malignant neoplasm within 5 years prior to the day of screening.

Contact the study team to confirm eligibility.