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A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa (FREEDOM)

Primary Purpose

Hemophilia A, Severe

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Efanesoctocog alfa
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemophilia A, Severe focused on measuring Blood coagulation disorder, Coagulation protein disorder, Haemophilia, FVIII, Efanesoctocog alfa

Eligibility Criteria

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

Key Inclusion Criteria: Previous treatment for haemophilia A with any marketed recombinant and/or plasma-derived FVIII for at least 150 EDs. Having received prophylactic treatment with any marketed recombinant and/or plasma FVIII or emicizumab per local label for at least 12 months preceding enrolment. Having 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and 6 months data on bleeding episodes prior to baseline visit. Willingness and ability to complete training in the use of the study ePD and to use the ePD in their own smartphone throughout the study. Willingness and ability to use the activity tracker provided by the sponsor to measure physical activity and heart rate. Be able and willing to administer efanesoctocog alfa intravenously at home. Key Exclusion Criteria: Serious musculoskeletal and/or neurological impairment limiting the mobility and the physical ability to a degree that makes the patient unsuitable for the study as judged by the investigator. Other known coagulation disorder(s) in addition to haemophilia A. History and/or current positive inhibitor test defined as ≥0.6 BU/mL. Treatment with NSAIDs above the maximum dose specified in the prescribing information within 2 weeks prior to screening. Systematic treatment within 12 weeks prior to screening with chemotherapy and/or other immunosuppressive drugs. Treatment with an investigational product within 30 days or 5.5 half-lives prior to screening, whichever is longer. Major surgery within 12 weeks prior to screening or planned major orthopaedic surgery to occur during the study. At baseline visit, patients who have not been compliant in using the activity tracker.

Sites / Locations

  • Investigational Site
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  • Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Efanesoctocog alfa

Arm Description

All patients will be treated intravenously once weekly with 50 IU/kg efanesoctocog alfa

Outcomes

Primary Outcome Measures

Change from baseline in International Physical Activity Questionnaire (IPAQ) scoring
The IPAQ is a validated, 7-day recall questionnaire measuring current levels of physical activity. Scoring of the IPAQ results in a continuous variable in the form of total MET-minutes per week. Higher scores means higher physical activity level.

Secondary Outcome Measures

Change from baseline in International Physical Activity Questionnaire (IPAQ) scoring
The IPAQ is a validated, 7-day recall questionnaire measuring current levels of physical activity. Scoring of the IPAQ results in a continuous variable in the form of total MET-minutes per week. Higher scores means higher physical activity level.
International Physical Activity Questionnaire (IPAQ) score
The IPAQ is a validated, 7-day recall questionnaire measuring current levels of physical activity. Scoring of the IPAQ results in a continuous variable in the form of total MET-minutes per week. Higher scores means higher physical activity level.
Change in mean daily minutes in physical activity
Tracker-recorded
Mean daily minutes of physical activity
Tracker-recorded
Change in type of workouts
Patient and tracker reported
Change in frequency of workouts
Patient and tracker reported
Change in duration of workouts
Patient and tracker reported
Change in patient reported intensity of workouts
The patient will report workouts in a patient diary and rate the intensity on a 5 level scale. The levels are: 1 = easy, 2 = moderate, 3 = slightly challenging, 4 = exhausting, 5 = very exhausting. The changes will be calculated on a intra-patient basis
Change in tracker recorded intensity of workouts
The patient will be provided with an activity tracker that will automatically record workouts when the patient is wearing the tracker. The intensity levels will be based on the heart rate and will be presented on a 4 level scale. The levels are: 1 = out of range, 2 = fat burn, 3 = cardio, 4 = peak
Mean value of patient and tracker reported type of workouts
Type of workout will be transcribed into a risk level of participating in a given activity for a haemophilia patient. Risk levels are based on a rating of 1-3 where level 1 represents a low risk of causing a bleeding episode and level 3 represents a high risk. The mean value will be calculated per 6-month period
Mean value of frequency of workouts
Patient and tracker reported
Mean value of duration of workouts
Patient and tracker reported
Mean value of patient reported intensity of workouts
The patient will report workouts in a patient diary and rate the intensity on a 5 level scale. The levels are: 1 = easy, 2 = moderate, 3 = slightly challenging, 4 = exhausting, 5 = very exhausting. The mean value will be calculated per 6-month period
Mean value of tracker recorded intensity of workouts
The patient will be provided with an activity tracker that will automatically record workouts when the patient is wearing the tracker. The intensity levels will be based on the heart rate and will be presented on a 4 level scale. The levels are: 1 = out of range, 2 = fat burn, 3 = cardio, 4 = peak The mean value will be calculated per 6-month period
Change in mean daily number of steps
Tracker-recorded
Mean daily number of steps
Tracker-recorded
Achieving WHO-recommended levels of MVPA
Tracker-recorded
Occurrence of bleeds in relation to workouts
Occurrence of pain in relation to workouts
Occurrence of injuries in relation to workouts
Occurrence of bleeding episodes impacting daily activity
Change from baseline in Haemophilia Joint Health Score (HJHS) score
The six index joints (elbows, knees and ankles) will be examined and scored. The minimum score per joint is 0, the maximum score is 20. In addition, Gait is scored on a scale from 0 to 4 based on the number of skills that are not within the normal limits. The total score will be the sum of scores across all six joints plus the gait score (range from 0 to 124, with 0 being normal and 124 being the most severe disease).
Change from baseline in Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US)
The HEAD-US joint score will be calculated for six joints, the right and left ankle, knee, and elbow joints. The specific joint score is made up of three item scores, disease activity (synovitis), disease damage of articular surfaces, and disease damage of subchondral bone. Specific joint score is the sum of the three item scores for each specific joint. Its values range from 0 (minimum) to 8 (maximum).The total score represents the sum of item scores for abnormalities detected.
Change from baseline in haemophilic arthropathy assessed by the International Prophylaxis Study Group (IPSG) Magnetic Resonance Imaging (MRI) scale
The IPSG scale is made up of two subscores, one for soft-tissue changes and one for osteochondral changes. MRI joint score is the sum of the soft tissue and osteochondral subscores for each joint, ranging from 0-17 where 0 is absence of damage. MRI total score is the sum of joint scores across all joints.
Target joint development (three or more spontaneous bleeds into a single joint within a consecutive 6-month period)
The number and proportion of patients with target joint development and the total number of target joint developed will be assessed.
Target joint resolution ( ≤2 bleeds into the joint within a consecutive 12-month period the joint is no longer considered a target joint)
The number and proportion of patients with target joint resolution and the total number of target joint resolutions will be assessed
Target joint recurrence (≥3 spontaneous bleeds in a single joint within any consecutive 6-month period after target joint resolution)
The number and proportion of patients with target joint recurrence and the total number of target joint recurrence will be assessed
Number of bleeding episodes
Annualized bleeding rate (ABR)
Total annualized efanesoctocog alfa consumption
Number of injections and dose to treat a bleeding episode
Pain reported via electronic patient diary
The patient will report pain (cause of pain, location and intensity. The intensity will reported as mild, moderately low, moderately high, severe and worst possible.
Pain intensity reported in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale - Pain Intensity 3a
The PROMIS Pain Intensity instrument assesses pain intensity on a 5-point Likert scale, ranging from 1 (had no pain) to 5 (very severe)
Pain interference reported in the Patient-Reported Outcomes Measurement Information System (PROMIS) scale - Pain interference 6a
The PROMIS Pain Interference 6a is a patient-assessed instrument and is to measure pain interference on a 5-point Likert scale, ranging from 1 (not at all) to 5 (very much)
Quality of life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
EQ-5D-5L assess 5 dimensions of health outcome (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each of the dimensions in the EQ-5D-5L questionnaire is divided into 5 levels: Level 1: indicating no problem Level 2: indicating slight problems Level 3: indicating moderate problems Level 4: indicating severe problems Level 5: indicating unable to/extreme problems Patients will select a level for each dimension that best describes their health status for that dimension. A 5 digit code will be obtained, made up of the response for each dimension. This code will then be converted to an index score.The EQ-5D-5L VAS is an overall assessment of health on a scale from 1-100 that the patient provides at the end of the EQ-5D-5L questionnaire. 100 represents the best health you can imagine and 0 represents the worst health you can imagine.
Assessment of treatment preference
This will be assessed with the Treatment Preference Survey that consists of 2 questions on perceived impact of treatment.
The occurrence of adverse events and serious adverse events
The occurrence of clinically significant changes
Assessed by physical examination, vital signs and laboratory tests
Development of inhibitors (neutralizing antibodies directed against FVIII)
Determined via the Nijmegen modified Bethesda assay
The occurrence of thrombotic and embolic events
Number of non-study medical care encounters
The number and proportion of patients having non-study medical care encounter visits will be described, as well as the corresponding total number of visits.
Duration of non-study medical care encounters
The duration of non-study medical care encounter visits will be described.

Full Information

First Posted
March 21, 2023
Last Updated
October 2, 2023
Sponsor
Swedish Orphan Biovitrum
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT05817812
Brief Title
A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa
Acronym
FREEDOM
Official Title
A Phase 3b Open-label Study Evaluating Physical Activity and Joint Health in Previously Treated Patients ≥12 Years With Severe Haemophilia A Treated With Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (Efanesoctocog Alfa) for 24 Months
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum
Collaborators
Syneos Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study. The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24. Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A, Severe
Keywords
Blood coagulation disorder, Coagulation protein disorder, Haemophilia, FVIII, Efanesoctocog alfa

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efanesoctocog alfa
Arm Type
Experimental
Arm Description
All patients will be treated intravenously once weekly with 50 IU/kg efanesoctocog alfa
Intervention Type
Drug
Intervention Name(s)
Efanesoctocog alfa
Other Intervention Name(s)
BIVV001
Intervention Description
Recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN)
Primary Outcome Measure Information:
Title
Change from baseline in International Physical Activity Questionnaire (IPAQ) scoring
Description
The IPAQ is a validated, 7-day recall questionnaire measuring current levels of physical activity. Scoring of the IPAQ results in a continuous variable in the form of total MET-minutes per week. Higher scores means higher physical activity level.
Time Frame
Baseline and month 24
Secondary Outcome Measure Information:
Title
Change from baseline in International Physical Activity Questionnaire (IPAQ) scoring
Description
The IPAQ is a validated, 7-day recall questionnaire measuring current levels of physical activity. Scoring of the IPAQ results in a continuous variable in the form of total MET-minutes per week. Higher scores means higher physical activity level.
Time Frame
Baseline and month 12
Title
International Physical Activity Questionnaire (IPAQ) score
Description
The IPAQ is a validated, 7-day recall questionnaire measuring current levels of physical activity. Scoring of the IPAQ results in a continuous variable in the form of total MET-minutes per week. Higher scores means higher physical activity level.
Time Frame
Baseline, month 6, 12, 18 and 24
Title
Change in mean daily minutes in physical activity
Description
Tracker-recorded
Time Frame
Run-in month, month 12 and 24
Title
Mean daily minutes of physical activity
Description
Tracker-recorded
Time Frame
Per 6-month period
Title
Change in type of workouts
Description
Patient and tracker reported
Time Frame
Run-in month, month 12 and 24
Title
Change in frequency of workouts
Description
Patient and tracker reported
Time Frame
Run-in month, month 12 and 24
Title
Change in duration of workouts
Description
Patient and tracker reported
Time Frame
Run-in month, month 12 and 24
Title
Change in patient reported intensity of workouts
Description
The patient will report workouts in a patient diary and rate the intensity on a 5 level scale. The levels are: 1 = easy, 2 = moderate, 3 = slightly challenging, 4 = exhausting, 5 = very exhausting. The changes will be calculated on a intra-patient basis
Time Frame
Run-in month, month 12 and 24
Title
Change in tracker recorded intensity of workouts
Description
The patient will be provided with an activity tracker that will automatically record workouts when the patient is wearing the tracker. The intensity levels will be based on the heart rate and will be presented on a 4 level scale. The levels are: 1 = out of range, 2 = fat burn, 3 = cardio, 4 = peak
Time Frame
Run-in month, month 12 and 24
Title
Mean value of patient and tracker reported type of workouts
Description
Type of workout will be transcribed into a risk level of participating in a given activity for a haemophilia patient. Risk levels are based on a rating of 1-3 where level 1 represents a low risk of causing a bleeding episode and level 3 represents a high risk. The mean value will be calculated per 6-month period
Time Frame
Per 6-month period
Title
Mean value of frequency of workouts
Description
Patient and tracker reported
Time Frame
Per 6-month period
Title
Mean value of duration of workouts
Description
Patient and tracker reported
Time Frame
Per 6-month period
Title
Mean value of patient reported intensity of workouts
Description
The patient will report workouts in a patient diary and rate the intensity on a 5 level scale. The levels are: 1 = easy, 2 = moderate, 3 = slightly challenging, 4 = exhausting, 5 = very exhausting. The mean value will be calculated per 6-month period
Time Frame
Per 6-month period
Title
Mean value of tracker recorded intensity of workouts
Description
The patient will be provided with an activity tracker that will automatically record workouts when the patient is wearing the tracker. The intensity levels will be based on the heart rate and will be presented on a 4 level scale. The levels are: 1 = out of range, 2 = fat burn, 3 = cardio, 4 = peak The mean value will be calculated per 6-month period
Time Frame
Per 6-month period
Title
Change in mean daily number of steps
Description
Tracker-recorded
Time Frame
Run-in month, month 12 and 24
Title
Mean daily number of steps
Description
Tracker-recorded
Time Frame
Per 6-month period
Title
Achieving WHO-recommended levels of MVPA
Description
Tracker-recorded
Time Frame
Run-in month, month 12 and 24
Title
Occurrence of bleeds in relation to workouts
Time Frame
Baseline to month 24
Title
Occurrence of pain in relation to workouts
Time Frame
Baseline to month 24
Title
Occurrence of injuries in relation to workouts
Time Frame
Baseline to month 24
Title
Occurrence of bleeding episodes impacting daily activity
Time Frame
Baseline to month 24
Title
Change from baseline in Haemophilia Joint Health Score (HJHS) score
Description
The six index joints (elbows, knees and ankles) will be examined and scored. The minimum score per joint is 0, the maximum score is 20. In addition, Gait is scored on a scale from 0 to 4 based on the number of skills that are not within the normal limits. The total score will be the sum of scores across all six joints plus the gait score (range from 0 to 124, with 0 being normal and 124 being the most severe disease).
Time Frame
Baseline, month 6, 12, 18, 24
Title
Change from baseline in Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US)
Description
The HEAD-US joint score will be calculated for six joints, the right and left ankle, knee, and elbow joints. The specific joint score is made up of three item scores, disease activity (synovitis), disease damage of articular surfaces, and disease damage of subchondral bone. Specific joint score is the sum of the three item scores for each specific joint. Its values range from 0 (minimum) to 8 (maximum).The total score represents the sum of item scores for abnormalities detected.
Time Frame
Baseline, month 12 and 24
Title
Change from baseline in haemophilic arthropathy assessed by the International Prophylaxis Study Group (IPSG) Magnetic Resonance Imaging (MRI) scale
Description
The IPSG scale is made up of two subscores, one for soft-tissue changes and one for osteochondral changes. MRI joint score is the sum of the soft tissue and osteochondral subscores for each joint, ranging from 0-17 where 0 is absence of damage. MRI total score is the sum of joint scores across all joints.
Time Frame
Baseline, month 24
Title
Target joint development (three or more spontaneous bleeds into a single joint within a consecutive 6-month period)
Description
The number and proportion of patients with target joint development and the total number of target joint developed will be assessed.
Time Frame
Month 6, 12, 18, 24
Title
Target joint resolution ( ≤2 bleeds into the joint within a consecutive 12-month period the joint is no longer considered a target joint)
Description
The number and proportion of patients with target joint resolution and the total number of target joint resolutions will be assessed
Time Frame
Month 6, 12, 18, 24
Title
Target joint recurrence (≥3 spontaneous bleeds in a single joint within any consecutive 6-month period after target joint resolution)
Description
The number and proportion of patients with target joint recurrence and the total number of target joint recurrence will be assessed
Time Frame
Month 6, 12, 18, 24
Title
Number of bleeding episodes
Time Frame
Per 6-month period and cumulative
Title
Annualized bleeding rate (ABR)
Time Frame
Baseline to month 24
Title
Total annualized efanesoctocog alfa consumption
Time Frame
Baseline to month 24
Title
Number of injections and dose to treat a bleeding episode
Time Frame
Baseline to month 24
Title
Pain reported via electronic patient diary
Description
The patient will report pain (cause of pain, location and intensity. The intensity will reported as mild, moderately low, moderately high, severe and worst possible.
Time Frame
Baseline to month 24
Title
Pain intensity reported in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale - Pain Intensity 3a
Description
The PROMIS Pain Intensity instrument assesses pain intensity on a 5-point Likert scale, ranging from 1 (had no pain) to 5 (very severe)
Time Frame
Baseline, month 6, 12, 18, 24
Title
Pain interference reported in the Patient-Reported Outcomes Measurement Information System (PROMIS) scale - Pain interference 6a
Description
The PROMIS Pain Interference 6a is a patient-assessed instrument and is to measure pain interference on a 5-point Likert scale, ranging from 1 (not at all) to 5 (very much)
Time Frame
Baseline, month 6, 12, 18, 24
Title
Quality of life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
Description
EQ-5D-5L assess 5 dimensions of health outcome (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each of the dimensions in the EQ-5D-5L questionnaire is divided into 5 levels: Level 1: indicating no problem Level 2: indicating slight problems Level 3: indicating moderate problems Level 4: indicating severe problems Level 5: indicating unable to/extreme problems Patients will select a level for each dimension that best describes their health status for that dimension. A 5 digit code will be obtained, made up of the response for each dimension. This code will then be converted to an index score.The EQ-5D-5L VAS is an overall assessment of health on a scale from 1-100 that the patient provides at the end of the EQ-5D-5L questionnaire. 100 represents the best health you can imagine and 0 represents the worst health you can imagine.
Time Frame
Baseline, month 6, 12, 18, 24
Title
Assessment of treatment preference
Description
This will be assessed with the Treatment Preference Survey that consists of 2 questions on perceived impact of treatment.
Time Frame
24 months
Title
The occurrence of adverse events and serious adverse events
Time Frame
From screening to month 24
Title
The occurrence of clinically significant changes
Description
Assessed by physical examination, vital signs and laboratory tests
Time Frame
Baseline, month 6, 12, 18, 24
Title
Development of inhibitors (neutralizing antibodies directed against FVIII)
Description
Determined via the Nijmegen modified Bethesda assay
Time Frame
Baseline, month 6, 12, 18, 24
Title
The occurrence of thrombotic and embolic events
Time Frame
From screening to month 24
Title
Number of non-study medical care encounters
Description
The number and proportion of patients having non-study medical care encounter visits will be described, as well as the corresponding total number of visits.
Time Frame
From baseline to month 24
Title
Duration of non-study medical care encounters
Description
The duration of non-study medical care encounter visits will be described.
Time Frame
From baseline to month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Previous treatment for haemophilia A with any marketed recombinant and/or plasma-derived FVIII for at least 150 EDs. Having received prophylactic treatment with any marketed recombinant and/or plasma FVIII or emicizumab per local label for at least 12 months preceding enrolment. Having 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and 6 months data on bleeding episodes prior to baseline visit. Willingness and ability to complete training in the use of the study ePD and to use the ePD in their own smartphone throughout the study. Willingness and ability to use the activity tracker provided by the sponsor to measure physical activity and heart rate. Be able and willing to administer efanesoctocog alfa intravenously at home. Key Exclusion Criteria: Serious musculoskeletal and/or neurological impairment limiting the mobility and the physical ability to a degree that makes the patient unsuitable for the study as judged by the investigator. Other known coagulation disorder(s) in addition to haemophilia A. History and/or current positive inhibitor test defined as ≥0.6 BU/mL. Treatment with NSAIDs above the maximum dose specified in the prescribing information within 2 weeks prior to screening. Systematic treatment within 12 weeks prior to screening with chemotherapy and/or other immunosuppressive drugs. Treatment with an investigational product within 30 days or 5.5 half-lives prior to screening, whichever is longer. Major surgery within 12 weeks prior to screening or planned major orthopaedic surgery to occur during the study. At baseline visit, patients who have not been compliant in using the activity tracker.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Program Leader
Phone
+46 8 697 20 00
Email
Sofia.Bergenstrale@sobi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Study Manager
Phone
+46 8 697 20 00
Email
Hanna.Jorbrink@sobi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silke Ehrenforth, MD, PhD
Organizational Affiliation
Swedish Orphan Biovitrum AB
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Vienna
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Brno
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Praha
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Le Kremlin-Bicêtre
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Berlin
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Gießen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Hamburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Homburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Munich
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Catanzaro
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Florence
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Naples
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Parma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Rome
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Oslo
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Solna
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Canterbury
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Newcastle Upon Tyne
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Investigational Site
City
Sheffield
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sobi's data sharing criteria and process for requesting access can be found at: https://www.sobi.com/en/policies
IPD Sharing URL
https://www.sobi.com/en/policies

Learn more about this trial

A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa

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