台灣臨床試驗主持人資料庫|TPIDB

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberBAY 1093884/19580

NCT Number(ClinicalTrials.gov Identfier)NCT03597022

2018-05-15 - 2021-06-11

Phase II

Terminated5

ICD-10D66

Hereditary factor VIII deficiency

Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors

Trial Applicant

BAYER TAIWAN COMPANY LTD.
Sponsor

bayer
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Sheng-chieh Chou Division of Hematology & Oncology

National Taiwan University Hospital

Co-Principal Investigator

莊名凱 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 余垣斌 Division of Hematology & Oncology

Far Eastern Memorial Hospital

Co-Principal Investigator

謝佩穎 Division of Hematology & Oncology
林世強 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 沈銘鏡 Division of Hematology & Oncology

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

林敬業 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator CHING-TIEN PENG Division of Pediatrics

China Medical University Hospital

Co-Principal Investigator

翁德甫 Division of Pediatrics

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator CHING-TIEN PENG 未分科

China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

CRO

Principal Investigator Chia-Yau Chang Division of Pediatrics

Taipei Medical University Hospital

Co-Principal Investigator

Yen-Lin Liu Division of Pediatrics

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

hemophilia A or B

Objectives

Primary objective:  To assess the safety and tolerability of multiple subcutaneous doses of BAY 1093884 in subjects with hemophilia A or B with or without inhibitors. Exploratory objectives:  To determine the number of bleeds over time during once weekly administration of BAY 1093884  To assess pharmacokinetics of BAY 1093884  To assess pharmacodynamics of BAY 1093884  To explore the effect of different doses of BAY 1093884 when administered once weekly, defined as the number of spontaneous bleeds which require additional treatment

Test Drug

BAY 1093884

Active Ingredient

BAY 1093884

Dosage Form

Solution

Dosage

150 mg/mL

Endpoints

The primary endpoint is safety as defined by the frequency of drug-related AEs, SAEs,
AESIs and clinically relevantc
abnormal laboratory values.
Another safety endpoint will be the frequency of binding and neutralizing antibodies against
BAY 1093884.

Inclution Criteria

1. Male subjects with:
•hemophilia A or hemophilia B (any severity) with inhibitors against FVIII or FIX (any inhibitor titer)
OR
•severe hemophilia A (FVIII activity <1%) or B (FIX activity <2%) without inhibitors.
Note: Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
2. Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
3. Age ≥18 years.
4. Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening.
5. For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.
6. For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing ITI.
7. Signed informed consent.

Exclusion Criteria

1. History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
2. History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.
3. Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).
4. History of cardiac, coronary and/or arterial peripheral atherosclerotic disease, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris or treatment for angina pectoris.
5. Platelet count <100,000/µL.
6. Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of <200/mm3.
7. Any planned major surgical intervention.
8. Subjects with known or suspected hypersensitivity to trial product(s) or related products.
9. Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
10. Subjects with advanced liver disease (signs of liver function impairment, e.g., albumin, vitamin K coagulation factors) and/or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >3 times the upper limit of the normal range and/or total bilirubin >2.0 times the upper limit of the normal range.
11. Subjects with serum creatinine >2.0 times the upper limit of the normal range.
12. Treatment with an investigational drug within 3 months prior to screening visit.
13. Subjects not willing to stop prophylaxis or ITI.

The Estimated Number of Participants

Taiwan

3 participants
Global

24 participants