EUCTR2016-001096-73-BG进行中（未招募）1 期
An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients with Knee Joint Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Medivir AB
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet all of the following criteria to be eligible for enrolment in this study:
- •1. Previously enrolled in Study MIV-711-201 including completion of Visit 8 either by
- •Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by NRS increase of =2
- •Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by NRS increase of =2
- •The NRS result will be derived using the primary endpoint from Study MIV-711-201: NRS average knee pain in the target knee with 7 days recall: increase from Baseline (Visit 2 of Study MIV-711-201) to Visit 8 of Study MIV-711-201.
- •2. Female patients must be non-pregnant, non-lactating and of nonchildbearing potential either as naturally(spontaneously) postmenopausal or due to hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy (as determined by patient medical history). Naturally (spontaneously) post-menopausal is defined as being amenorrhoeic for 12 months without an alternative medical cause and with a Screening follicle stimulating hormone test indicating
- •post-menopausal state.
- •3. Male patients should avoid fathering a child by either of the following methods:
- •True sexual abstinence: meaning that heterosexual abstinence is in line with the preferred and usual lifestyle of the patient (periodic abstinence such as that based on calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of a trial, or withdrawal/coitus interruptus are not acceptable methods of
- •contraception).
- •Willingness to use two effective means of contraception with their partner from the time of first IMP administration until 3 months after the last dose of IMP. Two or more of the following methods are acceptable and must include at least one barrier method: i) Surgical sterilization (i.e., bilateral tubal ligation for female partners; vasectomy for male), ii) placement of an intrauterine device or intrauterine system, iii) hormonal contraception (implantable, patch, oral), iv) barrier methods including condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. Male patients who have been sterilised are required to use one barrier method of contraception (condom).
- •4. The patient's usual analgesic regimen (in case of use) should remain the same as for Visit 8 in Study MIV-711-201 (i.e., Visit 1 in Study MIV- 711-202).
- •NOTE: If a patient is experiencing increased or decreased pain and requires an increase or a decrease in the dose of analgesics, or an occasional change of analgesics medication during his/her participation in the study, then this will be allowed and should be properly documented in the patient file and the CRF.
- •5. Needs to be able to communicate well with the investigators and staff.
- •6. Able to comply with the requirements of the study procedures and provide written informed consent prior to any study related procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients will be excluded from enrolment in this study if they meet any of the following criteria:
- •1. The presence of any inflammatory arthritis (e.g., gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy) or any underlying condition, other than OA, that may result in abnormal cartilage and bone metabolism.
- •2. Any generalised pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
- •3. Ongoing or a history of atrial fibrillation.
- •4. Currently receiving medication that affects cartilage or bone metabolism (other than study drug; hormone replacement therapy taken for more than 6 months is allowed).
- •5. Current or recurrent disease that could affect the action, absorption or disposition of MIV-711, or could affect clinical assessments or clinical laboratory assessments.
- •6. Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
- •7. Any medical condition, AE, clinical or laboratory finding from Study MIV-711-201 that, in the opinion of the Investigator, would preclude inclusion in the present clinical study.
- •8. Known or suspected intolerance or hypersensitivity to the investigational medicinal product, closely related compounds, or any of the stated ingredients.
- •9. History of alcohol or other substance abuse within the last year.
- •10. Use of an investigational product other than MIV-711 during participation in Study MIV-711-201 and /or active enrolment in another drug or vaccine clinical study.
- •11. Significant target knee injury or surgery during participation in Study MIV-711-201.
- •12. A history of partial or complete joint replacement surgery in the target knee at any time, listed for knee surgery, or anticipating knee surgery during the study period.
- •13. Any factor which, in the opinion of the investigator, would jeopardise the evaluation or safety of the patient or be associated with poor adherence to the clinical study protocol (e.g., inability to complete study diary, poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period).
- •14. Use of intra-articular hyaluronic acid in the target knee during participation in Study MIV-711-201.
- •15. Use of intra-articular, intra-muscular or oral corticosteroids during participation in Study MIV-711-201.
- •16. Commencement of non-pharmacological OA interventions during participation in Study MIV-711-201.
- •17. Vulnerable patients, e.g., patients kept in detention, soldiers, and employees of the sponsor or the Contract Research Organisation (CRO) with direct involvement in the proposed study or other studies under the direction of the investigator or the CRO, as well as family members of the employees or the investigator.
- •18. Lack of MRI of the knee from Visit 8 in Study MIV-711-201 due to special circumstances, such as claustrophobia or difficulties to fit the knee coil.
- •19. Patients with contra-indication to MRI of the knee.
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