EUCTR2014-001367-13-AT进行中（未招募）1 期
An open-label, prospective, single-centre, phase II study to assess dose and dose interval requirements with respect to efficacy and safety of AOP2014, PEG-Proline-Interferon alpha-2b, in patients with primary myelofibrosis (grade MF-0 and MF-1)
Medizinische Universtät Wien, Universitätsklinik für Innere Medizin I0 个研究点目标入组 24 人开始时间: 2014年7月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
入选标准
- •1.Written informed consent obtained prior to any study specific screening activities and able to comply with this protocol.
- •2.Patients age =18 years
- •3.Confirmed diagnosis of primary myelofibrosis (grade MF-0 and MF-1) according to the WHO criteria (2008). Including either
- •newly diagnosed Interferon naive patients or patients pre-treated with Pegasys® or PegIntron®, who had stable disease for
- •the previous 3 months.
- •4.If female of childbearing potential – have a negative urine pregnancy test result within 7 days prior to the scheduled first
- •application of investigational product and agree to employ adequate birth control measures for the duration of the study.
- •5.Eastern Cooperative Oncology Group performance status = 2.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.Diagnosis of any other myeloproliferative disorder
- •2.Any clinically significant illness or surgery within 4 weeks prior to dosing
- •3.Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- •4.Uncontrolled hypertension (systolic > 150 mmHg and diastolic > 100 mmHg, or clinically significant (i.e. active)
- •cardiovascular disease: CVA/stroke (= 3 months prior to enrolment), myocardial infarction (= 3 months prior to enrolment),
- •significant coronary artery stenosis, unstable angina, New York Heart Association (NYHA) Class 2 or greater Congestive
- •heart failure, or serious cardiac arrhythmia requiring medication.
- •5.History of malignant disease, including solid tumours (except basal cell and squamous cell carcinomas of the skin and
- •carcinoma in situ of the cervix that have been completely excised and are considered cured) and haematological
- •malignancies within the last 3 years
- •6. History of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected
- •intolerance to the investigational product
- •7. Use of any investigational drug or participation in any investigational drug study within the last 4 weeks
- •8.Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety
- •and sleep disorders
- •9. HADS score equal to or above 11 on either or both of the subscales (Appendix 3)
- •10. Any risk of suicide at screening or previous suicide attempts
- •11. Organ transplant, past or planned
- •12. Inadequate liver function defined by serum (total) bilirubin > 2,5 x ULN and/or AST and ALT > 2,5 x ULN
- •13.Clinically significant ECG findings
- •14.History of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy
- •15.Pregnant or lactating females (pregnancy test in fertile women to be assessed within 7 days prior to study treatment start)
- •16.Acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, thyroiditis,
- •psoriasis, lupus nephritis or any other autoimmune disorder)
- •17.Advanced primary Myelofibrosis (> Grade 2)
- •18.Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening
- •19.Any significant morbidity or abnormality which may interfere with the study participation
- •20.History of active substance or alcohol abuse within the last year
- •21.Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological
- •disorder (due to diabetes mellitus or hypertension)
- •22.Thyroid dysfunction not adequately controlled
- •23.Patients tested positively with TgAb and / or TPOAb at screening
- •24.History of uncontrolled severe seizure disorder
- •25.Leukocytopenia at the time of screening
- •26.Thrombocytopenia at the time of screening
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