Clinical Trials List
2022-09-01 - 2024-12-31
Phase I/II
Not yet recruiting1
Recruiting11
ICD-10M19.90
Unspecified osteoarthritis, unspecified site
ICD-9715.38
Osteoarthrosis, localized, not specified whether primary or secondary, other specified sites
A Phase I-II, Dose-escalation, Double-blinded, Placebo-controlled, and Dose-finding Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Osteoarthritis of the Knee
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Trial Applicant
Orient EuroPharma Co., Ltd.
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Sheng Chen 風濕免疫科
- Chao-Ching Chiang Division of Orthopedics
- 蔡弘正 風濕免疫科
- Chang-Youh Tsai 風濕免疫科
- 王建順 Division of Orthopedics
- Chien-Chih Lai 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王證琪 Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃錦前 Division of Orthopedics
- Zhi-Yu Chen Division of Orthopedics
- 陳冠豪 Division of Orthopedics
- 翁佩韋 Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳英州 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林宗立 Division of Orthopedics
- 謝尚霖 Division of Orthopedics
- 柯智淵 Division of Orthopedics
- 林珈郁 Division of Orthopedics
- Hsien-Te Chen Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 徐永衡 Division of Orthopedics
- Yu-Chih Lin Division of Orthopedics
- 胡志堅 Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzn-Min Lin 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李宜軒 Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Main evaluation indicators
1. 2ccPA Security
-Incidence of adverse events (AEs) and serious adverse events (SAEs)
- Changes in laboratory test results
- Changes in vital signs
-Physical examination findings
- Determine the maximum tolerated dose. When DLT is observed in greater than or equal to 1/3 of the subjects receiving 2ccPA at a certain dose, the dose level before that dose is defined as the maximum tolerated dose. If less than 1/3 of the subjects in the reduced dose group experience DLT, the maximum tolerated dose will be set as the reduced dose; if greater than or equal to 1/3 of the subjects in the reduced dose group experience DLT, the dose level of the previous dose group will be set as the maximum tolerated dose.
Issue 2
Main evaluation indicators
- Absolute change from baseline in WOMAC at day 85
Inclution Criteria
Signed written informed consent from any patient capable of giving consent.
Male or female patients, 40 to 80 years of age.
Documented clinical diagnosis of symptomatic OA affecting at least one knee of a minimum of 6 months prior to screening.
The study knee has OA of Grade 2 to 3 severity based on the Kellgren Lawrence grading scale.
A score > 6 and < 16 out of 20 on the WOMAC pain subscale for the study knee.
Pain in the study knee for most of the 30 days (i.e., more than half of the days) prior to randomization.
Women of childbearing potential must agree to practice a medically acceptable contraceptive regimen from screening visit until at least 1 month after the study treatment and must have a negative pregnancy test no earlier than 72 hours prior to study treatment. Male subjects must agree to practice a medically acceptable contraceptive regimen (i.e., sterilization surgery, barrier method, abstention) from screening visit until at least 1 month after the study treatment.
Exclusion Criteria
Patients with known or suspected hypersensitivity to 2ccPA or any of its excipients.
Use of intra-articular corticosteroids, hyaluronic acid, or other IA injection in the study knee within 3 months prior to study entry (randomization).
Use of chondroitin and/or glucosamine within 4 weeks prior to study entry (randomization).
Administered or requiring systemic or topical treatment of the study knee joint including immunosuppressive agents, anti-inflammatory drugs, steroids, or opioids for knee OA within 1 week prior to randomization. Acetaminophen (oral daily dose ≤ 3000 mg or topical use at any dose) can be taken up to 24 hours prior to randomization. For long-acting steroids (i.e., dexamethasone, betamethasone), subjects who received systemic treatment within 2 weeks before randomization will be excluded.
History of post-traumatic knee arthritis, or evidence of intra-articular bleeding of the study knee.
History of reiter's syndrome, gouty arthritis, systemic lupus erythematosus (SLE), sicca syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or any other immune disease that based on investigators' discretion.
Periarticular inflammation from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness or acute pain from injury.
Subjects with clinical signs and symptoms of active knee infection or being treated for knee infection at screening.
Arthroscopic or open surgery on the study knee within 6 months prior to study entry (randomization).
Prior knee replacement on the study knee or planned knee replacement during the study period.
Subjects with meniscus tears that require repairment surgery or known anterior cruciate ligament rupture.
Subjects with known severe synovitis, synovium necrosis in the study knee joint.
Subjects with known malignancy.
Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to study entry (randomization).
Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, dabigatran, or factor Xa inhibitors (rivaroxaban, apixaban, edoxaban, and betrixaban). Subject requiring routine use of low-dose aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded.
Abnormalities of laboratory parameters as described below will qualify for exclusion:
hemoglobin < 8 g/dL
total white blood cell count < lower limit of normal (LLN)
serum bilirubin/ alanine aminotransferase (ALT)/ aspartate aminotransferase AST > 2.5 times upper limit of normal (ULN)
serum creatinine > 2 times ULN
Pregnancy or lactation.
History of drug or alcohol dependence in the past 3 years.
Having known infection with HIV-1, active hepatitis B, or active hepatitis C. Patients who are inactive carriers of HBV or HCV can be enrolled if the subjects have stable baseline condition during the screening period.
Use of any investigational drug or participation in any drug study within 4 weeks prior to study entry (randomization).
Subjects unwilling or unable to comply with study procedures.
Any clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study as judged by the investigator.
The Estimated Number of Participants
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Taiwan
136 participants
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Global
0 participants
