EUCTR2006-003184-31-GB进行中（未招募）不适用
A double-blind, randomized, placebo-controlled, multi-center, Clinical Trial of ofatumumab, a fully human monoclonal anti-CD20 antibody in patients with moderate to severe stage Chronic Obstructive Pulmonary Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 60
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
- •1) Patients must have a diagnosis of COPD previously diagnosed by a physician (typical history, physical examination and spirometry) with persistent airway obstruction with FEV1/FVC < 70%
- •2) Male and Female
- •3) Age = 50 years
- •4) Former smokers since a minimum of 6 months and a maximum of 14 years having smoked = 15 cigarettes per day = 20 years (15 pack-years)
- •5) GOLD lower part of stage 2 and stage 3 (FEV1/FVC < 70%, 30% = FEV1 < 60% predicted)
- •6) Systemic steroid < 7.5 mg prednisolone daily during the last 4 weeks prior to screening
- •7) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Patients previously treated with ofatumumab
- •2) Resting transcutaneous oxygen saturation < 90%
- •3) Patients reversible on beta2 stimulating treatment (> 400 ml increase in FEV1)
- •4) Patients in long term home oxygen therapy (LTOT)
- •5) Exacerbation within the last 4 weeks prior to screening
- •6) Influenza vaccination within the last 4 weeks prior to screening
- •7) Patient currently participating in a pulmonary rehabilitation course
- •8) Past or current malignancy within the past 5 years except adequately treated:
- •- Cervical carcinoma Stage 1B or less
- •- Non-invasive basal cell and squamous cell skin carcinoma
- •- Malignant melanoma with a complete response of a duration of > 10 years
- •- Other cancer diagnoses with a complete response of a duration of > 5 years
- •9) Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis
- •10) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
- •11) Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
- •12)History of significant cerebrovascular disease
- •13)Known HIV positive
- •14) Positive serology for hepatitis B, defined as a positive test for HBsAg and/or a combination of a positive test for anti-HBs and anti HBc
- •15)Screening laboratory values:
- •- WBC < 3.0x10E9/L
- •- Neutrophils < 1.5 x10E9/L
- •- Platelets < 75 x10E9/L
- •- ALAT > 2.5 times the upper limit of normal
- •- ALP > 2.5 times the upper limit of normal
- •- Bilirubin > 1.5 times the upper limit of normal
- •- Creatinine > 1.5 the upper limit of normal.
- •16) Previous or current atopic disease such as hay fever, asthma, atopic dermatitis
- •17)Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening)
- •18) Current participation in any other interventional clinical study
- •19) Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- •20) Breast feeding women or women with a positive pregnancy test at Visit 1
- •21) Women of childbearing potential (Women are considered of childbearing potential unless they have been hysterectomized, have undergone tubal ligation within at least one year prior to Visit 1, or have been postmenopausal for at least one year) not willing to use adequate contraception as hormonal birth control or intrauterine device for the entire trial period during study and one year after last dose of ofatumumab.
- •22) Allergy to clemastine
- •23) Allergy to paracetamol
- •24) Glaucoma (contraindication for clemastine)
- •25) Problems with urination due to prostatic hyperplasia (contraindication for clemastine)
- •26) Patients on inhaled steroids and long acting beta2-agonists if not stable dose within 4 weeks prior to screening
研究者
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