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An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa (JOIN-us)

Primary Purpose

Hemophilia A, Hemophilia B

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US)
Haemophilia Joint Health Score (HJHS)
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemophilia A focused on measuring Blood coagulation disorder, Coagulation protein disorder, Haemophilia, FVIII, FIX, Efmoroctocog alfa, Eftrenonacog alfa

Eligibility Criteria

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

Inclusion Criteria: Age ≥ 6 years Diagnosis of haemophilia A or B Having at least 6 months documented pre-study treatment data regarding treatment prescriptions and bleeding episodes prior to the baseline visit Previous treatment for haemophilia A or B with any marketed recombinant and/or plasma-derived FVIII or FIX concentrate for at least 6 months Start of prophylactic treatment with rFVIIIFc or rFIXFc prior to study enrollment or latest at the baseline visit, in accordance with local regulations Signed and dated informed consent provided by the patient, or the patient's legally authorized representative for patients under the legal age. Assent should be obtained from paediatric patients in accordance with local regulations Exclusion Criteria: Any medical condition which in the opinion of the investigator makes the subject patient unsuitable for inclusion Prophylactic treatment with non-factor therapy during the 6 months prior to enrolment Presence of factor VIII or FIX inhibitory antibodies (inhibitors) (≥0.60 Bethesda Units [BU]/mL) at the latest available inhibitor test Enrolment in a concurrent clinical interventional study, or intake of an IMP, within three months prior to inclusion in this study Foreseeable inability to cooperate with given instructions or study procedures

Sites / Locations

  • Study site 100
  • Study site 101Recruiting
  • Study site 102
  • Study site 103
  • Study site 108
  • Study site 107
  • Study site 104
  • Study site 105
  • Study site 106
  • Study site 115
  • Study site 129
  • Study site 125
  • Study site 110Recruiting
  • Study site 123
  • Study site 124
  • Study site 111
  • Study site 126
  • Study site 120
  • Study site 121
  • Study site 113
  • Study site 119
  • Study site 130
  • Study site 118
  • Study site 117
  • Sudy site 122
  • Study site 109
  • Study site 112
  • Study site 128
  • Study site 114
  • Study site 131
  • Study site 132Recruiting
  • Study site 133
  • Study site 136
  • Study site 134
  • Study site 138
  • Study site 140
  • Study site 137
  • Study site 135
  • Study site 139
  • Study site 145Recruiting
  • Study site 141Recruiting
  • Study site 143
  • Study site 146
  • Study site 142Recruiting
  • Study site 147Recruiting
  • Study site 150
  • Study site 152
  • Study site 151
  • Study site 149
  • Study site 154Recruiting
  • Study site 156
  • Study site 153
  • Study site 157
  • Study site 155
  • Study site 158Recruiting
  • Study site 159

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Efmoroctocog alfa or eftrenonacog alfa

Arm Description

Efmoroctocog alfa or eftrenonacog alfa is prescribed and used according to usual clinical practice.

Outcomes

Primary Outcome Measures

Change from baseline in total HEAD-US score up to month 18 (end of study - EOS)
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). 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. The 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.

Secondary Outcome Measures

Change from baseline in HEAD-US score for hypertrophic synovium
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). The disease activity (synovitis) score rates the status of the hypertrophic synovium. Hypertrophic synovium is graded in three steps (0: absent/minimal; 1: mild/moderate [score=1], 2: severe [score=2]) based on the comprehensive evaluation of the joint recesses and the mean amount of synovial tissue contained in them.
Change from baseline in HEAD-US score for cartilage
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). Concerning the articular cartilage, the damage is graded in five steps (0: normal; 1: echotexture abnormalities and focal loss involving <25% of the target surface [score=1]; 2: partial/full-thickness loss of the cartilage involving at least 50% of the target surface [score=2]; 3: partial/full-thickness loss of the cartilage involving >50% of the target surface [score=3]; 4: complete cartilage destruction or absent visualization of the articular cartilage on the target surface [score=4]).
Change from baseline in HEAD-US score for bone
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). Damage of subchondral bone is scored using a three-grade scale (0: normal; 1: mild irregularities of the subchondral bone with/without initial osteophytes around the joint [score=1]; 2: deranged subchondral bone with/without erosions and presence of prominent osteophytes around the joint [score=2]).
Change from baseline in total Hemophilia Joint Health Score (HJHS) at month 18 (EOS)
The HJHS measures joint health, in the domain of body structure and function (i.e., impairment). 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).
Number of target joints
A target joint is defined as a joint with three or more spontaneous bleeds into the joint within a consecutive 6-month period. The study will evaluate the presence, resolution, recurrence, and new development of target joints.
Location of target joints
A target joint is defined as a joint with three or more spontaneous bleeds into the joint within a consecutive 6-month period. The study will evaluate the presence, resolution, recurrence, and new development of target joints.
Total annualized bleeding rate (ABR)
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location (e.g., muscle, joint, other), date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
Joint ABR
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location, date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
Target joint ABR
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location, date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
Traumatic/spontaneous ABR
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location (e.g., muscle, joint, other), date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
PROMIS physical function/activity short form 6b and 8a scores
Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated system of reliable and precise measures of patient-reported health status. PROMIS measures cover physical, mental, and social health, use a 5-point Likert response scale and a recall period of the past 7 days. The Numeric Rating Scale measures for adults (6b) consist of a single item rating physical function on average over the past 7 days, ranging from 5 (without any difficulty) to 1 (unable to do). Lower scores mean a worse outcome. The Numeric Rating Scale measures for pediatric and parent proxy (8a) each consist of a single item rating physical activity on average over the past 7 days, ranging from 1 (no days) to 5 (6-7 days). Lower scores mean a worse outcome.
PROMIS pain intensity 3a and 1a scores
Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated system of reliable and precise measures of patient-reported health status. PROMIS measures cover physical, mental, and social health, use a 5-point Likert response scale and a recall period of the past 7 days. The Numeric Rating Scale measures for adults (3a) consist of a single item rating pain over the past 7 days from 1 (had no pain) to 5 (very severe). Higher scores mean a worse outcome. The Numeric Rating Scale measures for pediatric and parent proxy (1a) each consist of a single item rating pain over the past 7 days, ranging from 0 (no pain) to 10 (worst pain you can think of). Higher scores mean a worse outcome.
PROMIS pain interference short form 6a and 8a scores
Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated system of reliable and precise measures of patient-reported health status. PROMIS measures cover physical, mental, and social health, use a 5-point Likert response scale and a recall period of the past 7 days. The Numeric Rating Scale measures (adult, pediatric, parent proxy) each consist of a single item rating pain interference with different activities over the past 7 days, ranging from 1 (not at all/never) to 5 (very much/almost always). Higher scores mean a worse outcome.
IPAQ-SF scores
International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF 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, as well as categorization into high, moderate, or low physical activity level. Higher scores mean higher physical activity level (better outcome).

Full Information

First Posted
April 24, 2023
Last Updated
September 11, 2023
Sponsor
Swedish Orphan Biovitrum
Collaborators
IQVIA Pvt. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05856266
Brief Title
An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
Acronym
JOIN-us
Official Title
An 18-month Low-interventional Prospective, Multicentre Study to Assess Joint Outcomes in Patients With Haemophilia A or B on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum
Collaborators
IQVIA Pvt. Ltd

4. Oversight

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

5. Study Description

Brief Summary
The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc. The main question it aims to answer is the: • Evaluation of the overall joint status as detected by ultrasound in haemophilia A and B patients treated with rFVIIIFc or rFIXFc prophylaxis over the 18-month study period. Participants will come to 6-monthly visits during the 18-month long study period and will perform an ultrasound with the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol at each visit. At baseline and end of study visits, the patients will be assessed with the clinical scoring system Haemophilia Joint Health Score (HJHS) and complete patient questionnaires. Retrospective data from patient medical records will also be collected for at least 6 months before enrolment in the study.
Detailed Description
The main purpose of this study is to prospectively describe the joint health over an 18-month period of prophylactic treatment with rFVIIIFc or rFIXFc in patients with haemophilia A or haemophilia B in a real-world setting in Europe. This is a low-interventional, multicentre study using point-of-care US examination for regular monitoring of joint health and detection of hypertrophic synovium, cartilage and bone damage. At the same time, clinical joint status will also be examined by HJHS. This study will evaluate the presence, resolution, recurrence, and new development of target joints. It will also describe bleeding episodes and evaluate the quality of life and physical activity with PROs. If patients are using the CE marked Florio HAEMO app in their routine clinical practice, they will be offered to participate in an optional sub-study that aims to explore possible correlations between the levels of physical activity, the estimated FVIII/FIX levels and bleeding occurrence.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This is a low-interventional study, with the drugs being prescribed and used according to clinical practice. The interventions in the study are the addition of the mandatory joint examinations HEAD-US (ultrasound) and HJHS (functional joint assessment).
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efmoroctocog alfa or eftrenonacog alfa
Arm Type
Other
Arm Description
Efmoroctocog alfa or eftrenonacog alfa is prescribed and used according to usual clinical practice.
Intervention Type
Procedure
Intervention Name(s)
Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US)
Intervention Description
Ultrasound examination
Intervention Type
Other
Intervention Name(s)
Haemophilia Joint Health Score (HJHS)
Intervention Description
Functional joint examination
Primary Outcome Measure Information:
Title
Change from baseline in total HEAD-US score up to month 18 (end of study - EOS)
Description
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). 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. The 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 and month 18
Secondary Outcome Measure Information:
Title
Change from baseline in HEAD-US score for hypertrophic synovium
Description
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). The disease activity (synovitis) score rates the status of the hypertrophic synovium. Hypertrophic synovium is graded in three steps (0: absent/minimal; 1: mild/moderate [score=1], 2: severe [score=2]) based on the comprehensive evaluation of the joint recesses and the mean amount of synovial tissue contained in them.
Time Frame
Baseline, month 6, 12 and 18
Title
Change from baseline in HEAD-US score for cartilage
Description
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). Concerning the articular cartilage, the damage is graded in five steps (0: normal; 1: echotexture abnormalities and focal loss involving <25% of the target surface [score=1]; 2: partial/full-thickness loss of the cartilage involving at least 50% of the target surface [score=2]; 3: partial/full-thickness loss of the cartilage involving >50% of the target surface [score=3]; 4: complete cartilage destruction or absent visualization of the articular cartilage on the target surface [score=4]).
Time Frame
Baseline, month 6, 12 and 18
Title
Change from baseline in HEAD-US score for bone
Description
HEAD-US is a standardized, fast, repeatable, and simple ultrasound scoring protocol for hemophiliac joints. The HEAD-US joint score will be calculated for the six index joints (elbows, knees, and ankles). Damage of subchondral bone is scored using a three-grade scale (0: normal; 1: mild irregularities of the subchondral bone with/without initial osteophytes around the joint [score=1]; 2: deranged subchondral bone with/without erosions and presence of prominent osteophytes around the joint [score=2]).
Time Frame
Baseline, month 6, 12 and 18
Title
Change from baseline in total Hemophilia Joint Health Score (HJHS) at month 18 (EOS)
Description
The HJHS measures joint health, in the domain of body structure and function (i.e., impairment). 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 and month 18
Title
Number of target joints
Description
A target joint is defined as a joint with three or more spontaneous bleeds into the joint within a consecutive 6-month period. The study will evaluate the presence, resolution, recurrence, and new development of target joints.
Time Frame
Baseline, month 6, 12 and 18
Title
Location of target joints
Description
A target joint is defined as a joint with three or more spontaneous bleeds into the joint within a consecutive 6-month period. The study will evaluate the presence, resolution, recurrence, and new development of target joints.
Time Frame
Baseline, month 6, 12 and 18
Title
Total annualized bleeding rate (ABR)
Description
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location (e.g., muscle, joint, other), date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
Time Frame
6 months retrospective period to baseline, baseline to 6 months, 6-12 months, 12-18 months and entire study period
Title
Joint ABR
Description
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location, date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
Time Frame
6 months retrospective period to baseline, baseline to 6 months, 6-12 months, 12-18 months and entire study period
Title
Target joint ABR
Description
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location, date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
Time Frame
6 months retrospective period to baseline, baseline to 6 months, 6-12 months, 12-18 months and entire study period
Title
Traumatic/spontaneous ABR
Description
For any bleeding episode, the following will be collected: bleeding episode circumstance (e.g., spontaneous, traumatic), bleeding episode location (e.g., muscle, joint, other), date of bleeding episode, dose (IU) and number of injections used to treat the bleed.
Time Frame
6 months retrospective period to baseline, baseline to 6 months, 6-12 months, 12-18 months and entire study period
Title
PROMIS physical function/activity short form 6b and 8a scores
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated system of reliable and precise measures of patient-reported health status. PROMIS measures cover physical, mental, and social health, use a 5-point Likert response scale and a recall period of the past 7 days. The Numeric Rating Scale measures for adults (6b) consist of a single item rating physical function on average over the past 7 days, ranging from 5 (without any difficulty) to 1 (unable to do). Lower scores mean a worse outcome. The Numeric Rating Scale measures for pediatric and parent proxy (8a) each consist of a single item rating physical activity on average over the past 7 days, ranging from 1 (no days) to 5 (6-7 days). Lower scores mean a worse outcome.
Time Frame
Baseline and 18 months
Title
PROMIS pain intensity 3a and 1a scores
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated system of reliable and precise measures of patient-reported health status. PROMIS measures cover physical, mental, and social health, use a 5-point Likert response scale and a recall period of the past 7 days. The Numeric Rating Scale measures for adults (3a) consist of a single item rating pain over the past 7 days from 1 (had no pain) to 5 (very severe). Higher scores mean a worse outcome. The Numeric Rating Scale measures for pediatric and parent proxy (1a) each consist of a single item rating pain over the past 7 days, ranging from 0 (no pain) to 10 (worst pain you can think of). Higher scores mean a worse outcome.
Time Frame
Baseline and month 18
Title
PROMIS pain interference short form 6a and 8a scores
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated system of reliable and precise measures of patient-reported health status. PROMIS measures cover physical, mental, and social health, use a 5-point Likert response scale and a recall period of the past 7 days. The Numeric Rating Scale measures (adult, pediatric, parent proxy) each consist of a single item rating pain interference with different activities over the past 7 days, ranging from 1 (not at all/never) to 5 (very much/almost always). Higher scores mean a worse outcome.
Time Frame
Baseline and month 18
Title
IPAQ-SF scores
Description
International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF 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, as well as categorization into high, moderate, or low physical activity level. Higher scores mean higher physical activity level (better outcome).
Time Frame
Baseline and month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 6 years Diagnosis of haemophilia A or B Having at least 6 months documented pre-study treatment data regarding treatment prescriptions and bleeding episodes prior to the baseline visit Previous treatment for haemophilia A or B with any marketed recombinant and/or plasma-derived FVIII or FIX concentrate for at least 6 months Start of prophylactic treatment with rFVIIIFc or rFIXFc prior to study enrollment or latest at the baseline visit, in accordance with local regulations Signed and dated informed consent provided by the patient, or the patient's legally authorized representative for patients under the legal age. Assent should be obtained from paediatric patients in accordance with local regulations Exclusion Criteria: Any medical condition which in the opinion of the investigator makes the subject patient unsuitable for inclusion Prophylactic treatment with non-factor therapy during the 6 months prior to enrolment Presence of factor VIII or FIX inhibitory antibodies (inhibitors) (≥0.60 Bethesda Units [BU]/mL) at the latest available inhibitor test Enrolment in a concurrent clinical interventional study, or intake of an IMP, within three months prior to inclusion in this study Foreseeable inability to cooperate with given instructions or study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rolf Schlosshauer, MSc
Phone
+46 8 697 20 00
Email
rolf.schlosshauer@sobi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Idah Larsson, MSc
Phone
+46 760 011 804
Email
idah.larsson@sobi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Lethagen, MD, PhD
Organizational Affiliation
Swedish Orphan Biovitrum AB (publ)
Official's Role
Study Director
Facility Information:
Facility Name
Study site 100
City
Sofia
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinov
Facility Name
Study site 101
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lissitchkov
Facility Name
Study site 102
City
Zagreb
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boban
Facility Name
Study site 103
City
Zagreb
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilic
Facility Name
Study site 108
City
Brno
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blatny
Facility Name
Study site 107
City
Liberec
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drbohlavova
Facility Name
Study site 104
City
Olomouc
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hlusi
Facility Name
Study site 105
City
Praha
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zapotocka
Facility Name
Study site 106
City
Praha
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salaj
Facility Name
Study site 115
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Castet
Facility Name
Study site 129
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Repesse
Facility Name
Study site 125
City
Chambéry
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jailler
Facility Name
Study site 110
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lebreton
Facility Name
Study site 123
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volot
Facility Name
Study site 124
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susen
Facility Name
Study site 111
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dargaud
Facility Name
Study site 126
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chambost
Facility Name
Study site 120
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frotscher
Facility Name
Study site 121
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drillaud
Facility Name
Study site 113
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lavigne Lissalde
Facility Name
Study site 119
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frenzel
Facility Name
Study site 130
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
d'Oiron
Facility Name
Study site 118
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Puyade
Facility Name
Study site 117
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colinart-Thomas
Facility Name
Sudy site 122
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bayart
Facility Name
Study site 109
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbay
Facility Name
Study site 112
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desprez
Facility Name
Study site 128
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oudot-Challard
Facility Name
Study site 114
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentin
Facility Name
Study site 131
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nemes
Facility Name
Study site 132
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nolan
Facility Name
Study site 133
City
Dublin
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
O'Connell
Facility Name
Study site 136
City
Bologna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valdre
Facility Name
Study site 134
City
Brescia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gorio
Facility Name
Study site 138
City
Catania
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuffrida
Facility Name
Study site 140
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mancuso
Facility Name
Study site 137
City
Palermo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Napolitano
Facility Name
Study site 135
City
Pisa
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernasconi
Facility Name
Study site 139
City
Vicenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tosetto
Facility Name
Study site 145
City
Baia Mare
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Truica
Facility Name
Study site 141
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brinza
Facility Name
Study site 143
City
Craiova
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ocroteala
Facility Name
Study site 146
City
Iaşi
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tărniceriu
Facility Name
Study site 142
City
Timişoara
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florica
Facility Name
Study site 147
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faganel Kotnik
Facility Name
Study site 150
City
Alicante
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boronat
Facility Name
Study site 152
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arranz
Facility Name
Study site 151
City
Coruña
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gómez del Castillo Solano
Facility Name
Study site 149
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvarez Román
Facility Name
Study site 154
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lopez Jaime
Facility Name
Study site 156
City
Oviedo
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soto Ortega
Facility Name
Study site 153
City
Salamanca
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bastida Bermejo
Facility Name
Study site 157
City
Valencia
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonanad
Facility Name
Study site 155
City
Valladolid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
García Frade
Facility Name
Study site 158
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Calvo Villas
Facility Name
Study site 159
City
Belfast
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benson

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa

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