Clinical Trials List
2016-05-04 - 2020-10-31
Phase II
Terminated5
ICD-10M36.2
Hemophilic arthropathy
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT TRIAL OF AC-201 CONTROLLED RELEASE TABLETS IN SUBJECTS WITH HEMOPHILIC ARTHROPATHY
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Trial Applicant
TWI BIOTECHNOLOGY, INC
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Sponsor
twi bio
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Jan-Wen Ku Division of Radiology
- Shih-Wei Huang Division of Rehabilitation Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Pei-Chin Lin Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Juinn-Horng Kang Division of Rehabilitation Medicine
The Actual Total Number of Participants Enrolled
10 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Change from baseline in IPSG (MRI) score at Week 24 for primary knee
Secondary Endpoints:
• Change from baseline in IPSG (MRI) score at Week 24 for non-primary knee
• Change from baseline in IPSG score at Week 48 by knee
• Change from baseline in IPSG component scores at Week 24 and Week 48 by knee
• Change from baseline in MRI-measured synovial thickness at Week 24 and Week 48 by knee
• Change from baseline in ultrasonographic synovial thickness and hyperemia score at Week 24
and Week 48 by knee
• Change from baseline in knee pain (by VAS) at each visit by knee
• Short Form-36 score and change from baseline at Week 24 and Week 48
• Concentration of inflammation markers and change from baseline at Week 24 and Week 48
Inclution Criteria
2 Diagnosis of Hemophilia A or B
3 Clinical diagnosis of hemophilic arthropathy for at least 6 months
4 Pettersson score (based on X-ray) of 0 to 6 in at least one knee within 1 year of screening
5 Is able to read, understand, and sign the Informed Consent Form (ICF), communicate with the investigator,
complete study diaries, and understand and comply with protocol requirements
Exclusion Criteria
2 Presence of joint infections in the primary knee
3 Knee surgery within 6 months prior to screening in the primary knee.
4 Intra-articular hyaluronic acid (IAHA) or platelet-rich plasma (PRP) injection in the primary knee within 6 months prior to screening
5 Use of any of the following medications after the screening visit:
a. NSAID injection (oral NSAIDs including COX-2 inhibitors allowed)
b. Glucosamine or chondroitin
6 History of high responder inhibitory antibodies to factor VIII or factor IX clotting factor, with titer >5 Bethesda units (BU)/mL, OR clinical evidence for presence of factor inhibitor.
7 History of rheumatoid arthritis or gouty arthropathy
8 History of allergy or hypersensitivity to any component of study medication, including diacerein, or to rhein or any anthraquinone derivatives
9 Any prior use of biologic anti-inflammatory therapy, including IL-1 modulators (anakinra, rilonacept, or ca nakinumab), tumor necrosis factor inhibitors (etanercept, adalimumab, or golimumab), IL-6 inhibitors (tocil izumab), or T-cell costimulation modulators (abatacept) within 6 months prior to screening
10 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2x the upper limit of lab oratory normal range (ULN), or bilirubin >1.5x ULN at screening
11 Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or TB (by chest X-ray)
12 Detectable hepatitis C virus (HCV) with either of the following:
a. FibroTest score >0.48 (i.e., significant liver fibrosis stage F2, F3 or F4)
b. Child-Pugh score ≥6
13 History of cirrhosis
14 Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2; estimated using the MDRD equation) at screening
15 History of solitary kidney, post-renal transplant, or renal failure requiring regular dialysis treatments
16 History of clinically significant cardiovascular disease, including significant edema, congestive heart failure, New York Heart Association Class III or Class IV cardiac status, unstable angina, myocardial infarction, uncontrolled arrhythmias, cerebrovascular accident, transient ischemic attack, or any revascularization procedure, within 1 year prior to screening
17 History of inflammatory bowel disease or irritable bowel syndrome
18 History of malignant disease (with the exception of basal and squamous cell carcinoma of the skin, in situ cervical carcinoma, or in situ prostate cancer) within 5 years of screening
19 Any clinically significant medical condition or laboratory value that could potentially affect study participation and/or personal well-being, as judged by the investigator
20 Has participated in any diacerein studies within 1 year prior to screening
21 Has participated in a clinical study within 30 days prior to screening
22 Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with the study at the clinical study site
23 Is employed by the sponsor (i.e., is an employee, temporary contract worker, or designee responsible for the conduct of the study)
The Estimated Number of Participants
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Taiwan
24 participants
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Global
24 participants
