NL-OMON50716已完成3 期
A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal
Bioverativ USA, Inc.0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Adult males and females >= 18 years of age at Screening
- •2.Body weight of >= 39 kg at screening
- •3.Confirmed diagnosis of primary CAgD based on the following criteria:
- •a.Chronic hemolysis,
- •b.Polyspecific direct antiglobulin test (DAT) positive,
- •c.Monospecific DAT strongly positive for C3d,
- •d.Cold agglutinin titer >= 64 at 4 degrees Celsius,
- •e.IgG DAT <= 1+, and
- •f.No overt malignant disease
- •4.History of at least one documented blood transfusion within 6 months
- •of enrollment
- •5.Hemoglobin level <= 10.0 g/dL
- •6.Bilirubin level above the normal reference range
- •7.Ferritin level within the normal reference ranges unless outside normal range
- •and deemed not clinically significant by the Investigator (or designee)
- •8.Presence of one or more of the following CAgD-related signs or
- •symptoms within 3 months of Screening:
- •a.Symptomatic anemia defined as:
- •ii.Weakness,
- •iii.Shortness of breath,
- •iv.Palpitations, fast heart beat
- •v.Light headedness and/or
- •vi.Chest pain
- •b.Acrocyanosis
- •c.Raynaud's syndrome
- •d.Hemoglobinuria
- •e.Disabling circulatory symptoms, and/or
- •f.Major adverse vascular event (including thrombosis)
- •9.Bone marrow biopsy within 6 months of Screening with no overt
- •evidence of lymphoproliferative disease or other hematological
- •malignancy. An additional bone marrow biopsy will be required if the
- •prior bone marrow is deemed unsuitable for analysis by the Sponsor.
- •10.Vaccinations against encapsulated bacterial pathogens (Neisseria meningitis,
- •Meningitis B, Haemophilus
- •influenzae, and Streptococcus pneumoniae) within 5 years of enrollment or as
- •specified in Appendix B.
- •11. Adequate IV access
- •12. If female, must be post-menopausal, surgically sterile, or be established
- •on (>= 3 months prior to Screening)
- •and agree to continue to use the same highly effective methods of birth control
- •throughout the study and for 6
- •weeks following administration of the last dose of study drug
- •13. Males must be surgically sterile for at least 90 days or when sexually
- •active with female partners of childbearing
- •potential will agree to use highly effective contraception from Day 0 until 6
- •weeks days following
- •administration of the last dose of study drug.
- •14. Able to comprehend and give informed consent
- •15. Able to comply with the requirements of the study and to complete
- •the full sequence of protocol-related procedures.
排除标准
- •1.Cold agglutinin syndrome secondary to infection, rheumatologic
- •XML File Identifier: dunyrSdLPtdNi1xM53CpqaxPjDI=
- •disease, or active hematologic malignancy
- •2.Clinically relevant infection of any kind within the month preceding
- •enrollment (eg, active hepatitis C, pneumonia)
- •3.Clinical diagnosis of systemic lupus erythematosus (SLE); or other
- •autoimmune disorders with anti-nuclear antibodies at Screening.
- •4.Positive hepatitis panel (including hepatitis B surface antigen and/or
- •hepatitis C virus antibody) prior to or at Screening
- •5.Positive human immunodeficiency virus (HIV) antibody at Screening
- •6.Treatment with rituximab monotherapy within 3 months or rituximab
- •combination therapies (eg, with bendamustine, fludarabine, ibrutinib, or
- •cytotoxic drugs) within 6 months prior to enrollment
- •7.Concurrent treatment with corticosteroids other than a stable daily
- •dose equivalent to <= 10 mg/day prednisone for previous 3 months
- •8.Erythropoietin deficiency. Concurrent treatment with erythropoietin is
- •permitted if the patient has been on a stable dose for the previous 3
- •9.Concurrent usage of iron supplementation unless the patient has been
- •on a stable dose for at least 4 weeks.
- •10.Clinically significant medical history or ongoing chronic illness that
- •would jeopardize the safety of the patient or compromise the quality of
- •the data derived from his/her participation in this study (as determined
- •by the Investigator [or designee]) at Screening
- •11.Concurrent treatment with other experimental drugs or participation
- •in another clinical trial with any investigational drug within 30 days or 5
- •half lives, whichever is greater, prior to treatment start
- •12.Females who are pregnant, lactating, or, if having reproductive
- •potential, are considered potentially unreliable with respect to
- •contraceptive practice
研究者
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