NL-OMON52611已完成2 期
An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients - Clinical study of imlifidase in patients with Guillain-Barré Syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
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. Signed Informed Consent obtained before any study-related procedures.
- •2. Willingness and ability to comply with the protocol.
- •3. Male or female aged >=18 years at the time of screening.
- •4. GBS diagnosed according to National Institute of Neurological Disorders and
- •Stroke (NINDS) diagnostic criteria (Asbury et al. 1990)
- •5. Onset of weakness due to GBS is not more than 10 days prior to screening.
- •6. Unable to walk unaided for >10 meters (grade >= 3 on GBS DS).
- •7. IVIg treatment being considered.
- •8. Women of child-bearing potential willing or able to use at least one highly
- •effective contraceptive method from the day of treatment until at least 6
- •months after the dose of imlifidase if not abstinent. In the context of this
- •study, an effective method is defined as those which result in low failure rate
- •(i.e. less than 1% per year) when used consistently and correctly.
- •9. Men willing to use double-barrier contraception from the day of treatment
- •until at least 2 months after the dose of imlifidase if not abstinent.
排除标准
- •1. Previous treatment with imlifidase.
- •2. Previous IVIg treatment within 28 days prior to imlifidase treatment.
- •3. Subjects who are being considered for, or already on, PE.
- •4. Women of childbearing potential who are not willing to use contraception
- •from the screening visit until at least 180 days following imlifidase dosing.
- •5. Breastfeeding or pregnancy
- •6. Clinical evidence of a polyneuropathy of another cause e.g. diabetes
- •mellitus (except mild sensory), alcoholism, vitamin deficiency, or porphyria.
- •7. Known selective IgA deficiency
- •8. Hypersensitivity to IVIg or to any of the excipients.
- •9. Immunosuppressive treatment (e.g. azathioprine, cyclosporine,
- •mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolone daily)
- •during the last month.
- •10. Subject known to have a severe concurrent disease, e.g. malignancy, severe
- •cardiovascular disease and severe chronic obstructive pulmonary disease (COPD).
- •11. Any condition that in the opinion of the investigator could increase the
- •subject*s risk by participating in the study or confound the outcome of the
- •12. Known mental incapacity or language barriers precluding adequate
- •understanding of the Informed Consent information and the study activities.
- •13. Subjects with clinical signs of ongoing infection.
- •14. Subjects who have received other investigational drugs within 5 half-lives
- •prior to imlifidase dosing. A subject will be withdrawn from the study if more
- •than 12 days elapse between the onset of weakness and planned imlifidase
- •administration, thus preventing that the administration of IVIg after
- •imlifidase administration would be later than 14 days after onset of weakness.
- •15. Present or history of thrombotic thrombocytopenic purpura (TTP), or known
- •familial history of TTP.
- •16. Positive PCR test for SARS-CoV-2 virus infection.
研究者
相似试验
进行中（未招募）
1 期
A clinical study investigating the safety and effect of Imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS)Guillain-Barré Syndrome (GBS)MedDRA version: 26.0Level: LLTClassification code 10018766Term: Guillain Barre syndromeSystem Organ Class: 10029205 - Nervous system disordersEUCTR2018-001059-12-NLHansa Biopharma AB30
进行中（未招募）
1 期
A clinical study investigating the safety and effect of Imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS)Guillain-Barré Syndrome (GBS)MedDRA version: 21.1Level: LLTClassification code 10018766Term: Guillain Barre syndromeSystem Organ Class: 100000004852EUCTR2018-001059-12-GBHansa Biopharma AB30
进行中（未招募）
不适用
A study to investigate the efficacy and safety of the PC-A11 treatment in patients with head and neck cancers.Recurrent head and neck squamous cell carcinoma (HNSCC) insuitable for surgery and radiotherapyMedDRA version: 17.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003751-19-ESPCI Biotech AS92
进行中（未招募）
不适用
A study to investigate the efficacy and safety of the PC-A11 treatment in patients with head and neck cancers.Recurrent head and neck squamous cell carcinoma (HNSCC) insuitable for surgery and radiotherapyMedDRA version: 18.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003751-19-LTPCI Biotech AS99
进行中（未招募）
1 期
A study to investigate the efficacy and safety of the PC-A11 treatment in patients with head and neck cancers.Recurrent head and neck squamous cell carcinoma (HNSCC) insuitable for surgery and radiotherapyMedDRA version: 18.0 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003751-19-GBPCI Biotech AS99