- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695391
A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM (SCOPE HIM)
May 2, 2024 updated by: Laboratoire français de Fractionnement et de Biotechnologies
A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures
This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
19
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric CARBONNELLE
- Phone Number: +33169821729
- Email: carbonnellee@lfb.fr
Study Locations
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Sabah Province
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Kota Kinabalu, Sabah Province, Malaysia, 88586
- Not yet recruiting
- Hospital Queen Elisabeth - Kota Kinabalu
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Contact:
- Lily WONG LEE LEE, MD
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Selangor Province
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Ampang, Selangor Province, Malaysia, 68000
- Not yet recruiting
- Hospital Ampang
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Contact:
- Veena SELVARATNAM, MD
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-
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Not yet recruiting
- Hospital Universitario Dr. José Eleuterio González de Nuevo León
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Contact:
- Laura VILLARREAL, MD
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-
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Gauteng Province
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Johannesburg, Gauteng Province, South Africa, 2196
- Recruiting
- Charlotte Maxeke Johannesburg Academic Hospital
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Contact:
- Johnny MAHLANGU, MD
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Chiang Mai, Thailand, 50200
- Not yet recruiting
- Chiang Mai University
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Contact:
- Chatree CHAI-ADISAKSOPHA, MD
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Chiang Mai, Thailand, 50200
- Not yet recruiting
- Maharaj Nakorn Chiangmai Hospital, Chiangmai University
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Contact:
- Rungrote NATESIRINILKUL, MD
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Adana Province
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Seyhan, Adana Province, Turkey, 01130
- Not yet recruiting
- Acibadem Adana Hospital
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Contact:
- Ali Bulent ANTMEN, MD
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Istanbul Province
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Fatih, Istanbul Province, Turkey, 34098
- Not yet recruiting
- İstanbul Üniversitesi - Cerrahpaşa Cerrahpaşa Tıp Fakültesi
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Contact:
- Osman Bulent ZULFIKAR, MD
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-
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Georgia
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Atlanta, Georgia, United States, 30322
- Not yet recruiting
- Children's Healthcare of Atlanta
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Contact:
- Robert SIDONIO Jr, MD
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Not yet recruiting
- Tulane Univertsity School of Medecine
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Contact:
- Maissaa JANBAIN, MD
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- M Health Fairview Center for bleeding and Clotting disorders
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Contact:
- Marshall MAZEPA, MD
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Texas
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Houston, Texas, United States, 77030
- Not yet recruiting
- University of Texas Health Science, center of Houston
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Contact:
- Miguel ESCOBAR, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Each patient must meet the following criteria to be enrolled in this study:
- be male with a diagnosis of congenital hemophilia A or B of any severity
have one of the following:
- positive inhibitor test BU ≥5 (as confirmed at screening by the institutional lab) OR
- an inhibitor test BU <5 (as confirmed at screening by the institutional lab) but expected to have an anamnestic response to FVIII or FIX, as demonstrated by a history of a high-responding inhibitor manifested by a previous anamnestic response, defined as a peak inhibitor titer >5 BU after re-exposure to factor concentrates, precluding the use of FVIII or FIX products to treat or prevent bleeding OR
- an inhibitor test BU <5 (as confirmed at screening by the institutional lab) but expected to be refractory to FVIII or FIX, as demonstrated by the patient's history of previous failure to respond to FVIII or FIX concentrates, even in the absence of a documented anamnestic response, precluding the use of FVIII or FIX products to treat or prevent bleeding episodes.
- be ≥12 years to ≤65 years of age on the day of informed consent
- be scheduled for an elective major surgical procedure as defined in the study protocol (see Table ''Definitions for the specific purpose of Study F7TG2202'')
- have Hb ≥ 12 g/dL
- be capable of understanding and willing to comply with the conditions of the protocol OR in the case of a patient under the age of legal majority, parent(s)/legal guardian(s) must be capable of understanding and willing to comply with the conditions of the protocol
- have read, understood, and provided written informed consent (patient or parent(s)/legal guardian(s) if the patient is minor according to local regulation) and, where applicable according to local regulation, patient's assent if the patient is minor -
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
- have any coagulation disorder other than hemophilia A or B
- be immunosuppressed (i.e. the patient should not be receiving systemic immunosuppressive medication; CD4+ cell counts at screening should be >200/μL)
- known intolerance to LR769 or any of its excipients
- currently receiving immune tolerance induction (ITI) therapy
- have a known or suspected allergy or hypersensitivity to rabbits or rabbit proteins
- have platelet count <100,000/μL
- have received an investigational drug within 30 days or within 5 half-lives of that investigational drug, whichever is longer, of the planned first LR769 administration, or be expected to receive such drug during participation in this study. Patients who have received fitusiran in a clinical study may not participate in this clinical study for 6 months since the last dose and if they have an antithrombin III level not in the normal range at screening.
- for patients using emicizumab, have received during the last 6 months or currently receiving a maintenance dosing regimen of emicizumab different from the indicated one ± 10% of approved dose), i.e. different from 1.5 mg/kg once weekly (±10%), 3 mg/kg (±10%) every two weeks or 6 mg/kg (±10%) every four weeks
- for patients using emicizumab, currently be any plans, or notes in the patient's medical records that would suggest the need to increase or decrease emicizumab dosing due to antidrug antibodies (ADAs), reduced PK, or coagulation/safety-related issues (e.g. lack of response, or potential/actual thromboembolic concerns, etc)
- have a clinically relevant hepatic (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times the upper limit of normal [ULN]) and/or renal impairment (creatinine >2 times the ULN)
- have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, DVT, or PE) within 2 years prior to the planned first dose of LR769, uncontrolled arrhythmia, or current New York Heart Association (NYHA) functional classification score of stages II - IV
- have an active malignancy (those with non-melanoma skin cancer are allowed)
- have any life-threatening disease or other disease or condition which, according to the investigator's judgment, could imply a potential hazard to the patient, or interfere with the study participation or study outcome (e.g. chronic, unmanaged hepatitis infection)
- be using aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), herbs, natural medications, or other drugs with platelet inhibitory properties within one week prior to surgery and for the duration of treatment with LR769
- have active gastric or duodenal ulcer disease
- have received a FVII- or FVIIa-containing product (either plasma derived or recombinant) within 24 hours prior to administration of LR769
- have a contraindication to antifibrinolytics
- have planned combined major surgeries at the same time
- be administered pharmacologic thromboprophylaxis within 5 half-lives of that medication before surgery or for the duration of treatment with LR769 -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coagulation Factor VIIa (Recombinant)
|
LR769
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of successfully at wound closure
Time Frame: at wound closure
|
proportion of successfully treated major procedures defined by a good or excellent global hemostatic response.
|
at wound closure
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proportion of successfully at 24 hours after surgery
Time Frame: at 24 hours after surgical wound closure
|
proportion of successfully treated major procedures defined by a good or excellent global hemostatic response.
|
at 24 hours after surgical wound closure
|
proportion of successfully at 120 hours after surgery
Time Frame: at 120 hours after surgical wound closure
|
proportion of successfully treated major procedures defined by a good or excellent global hemostatic response.
|
at 120 hours after surgical wound closure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
December 21, 2022
First Submitted That Met QC Criteria
January 12, 2023
First Posted (Actual)
January 25, 2023
Study Record Updates
Last Update Posted (Estimated)
May 3, 2024
Last Update Submitted That Met QC Criteria
May 2, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F7TG2202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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