NCT00645749已完成1 期
Helminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple Sclerosis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- MS activity, as judged by the number of new gadolinium-enhancing lesions on serial MRI scans
研究概览
简要总结
The hypothesis of this study is that helminth-induced immunomodulation therapy (HINT) will be safe and effective when administered orally in patients with relapsing-remitting multiple sclerosis (RRMS).
详细描述
Phase 1 of the HINT trial was completed with enrollment of 5 subjects. HINT Phase 2 is now closed to enrollment of 15 subjects. Recruitment sites are the UW-Madison and the Marshfield Clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •McDonald Committee (2010) criteria for RRMS (MS) .
- •ambulatory patients with disability scores of EDSS 0.-5.0
- •male or female subjects; ages 18-50
- •diagnosis within three years of study entry, based on either a) two or more clinical attacks in the three years prior to entry or b) one attack within three years of entry, coupled with MRI evidence of dissemination in space and time by strict application of McDonald Committee MRI criteria
- •active MRI at entry, as evidenced by at least one gd+ enhancing lesion during screening
- •explicit refusal to be treated with conventional disease-modifying medications (DMT) for RRMS, after full discussion of the potential benefits and risks of these agents and after review of the National Multiple Sclerosis Advisory Statement DMT.
- •ability to provide written informed consent
排除标准
- •patients who are unwilling or unable to give written informed consent or to follow the protocol successfully
- •allergy to Trichuris species
- •treatment with metronidazole (Flagyl) or other medications with anti-helminth effects (IB 5.7)
- •previous or anticipated treatment with FDA-approved or other experimental medications for RRMS
- •previous treatment with immunosuppressive therapy, cytotoxic chemotherapy, or lymphoid irradiation for any reason
- •insulin dependent diabetes mellitus
- •history of HIV-1, HTLV-1, viral hepatitis, or Lyme disease.
- •requirement for chronic, sustained aspirin or non-steroidal anti-inflammatory medications (e.g., use of more than 5-6 days per month for transient symptoms)
- •significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
- •presence or history of cancer of any type (except successfully treated basal cell or squamous cell carcinoma of skin)
- •history of alcohol or drug abuse in last 12 months; chronic liver or biliary disease; AST or ALT determination greater than two times the upper limit of normal
- •any of the following laboratory abnormalities: serum creatinine > 1.7 mg/DL, white blood count < 3,500/mm3, lymphocyte count < 800/mm3
- •special subjects such as minor children, mentally disabled persons, or prisoners
- •any contraindication to MRI scanning, including significant claustrophobia or sensitivity to gadolinium contrast agent
- •pregnancy and lactation; women of childbearing potential must have a documented negative serum beta HCG pregnancy test at entry and during the study and must be willing to practice adequate birth control for the duration of the study
- •any MS attack or treatment with corticosteroid medication within 30 days of study entry (corticosteroids may be used during the study for MS relapses per the judgment of the treating physician, IB 5.7, IB 6.1.3)
- •immediate household or family contacts who are immunodeficient or immunosuppressed
- •history of parasitism or positive determination ova and parasite stool at screening
研究组 & 干预措施
Helminth ova
Experimental
Subjects serving as their own controls (baseline - end-of-treatment) will receive a dose of 2,500 ova, in liquid form, every 2 weeks
干预措施: Helminth ova (Biological)
结局指标
主要结局
MS activity, as judged by the number of new gadolinium-enhancing lesions on serial MRI scans
时间窗: Up to 19 months
MS activity will be assessed based on the number of new gadolinium-enhancing lesions on serial MRI scans.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected AdultsHIV InfectionsNCT00124007National Institute of Allergy and Infectious Diseases (NIAID)114
已完成
不适用
ipid emulsion (drug) in Acute on Chronic Liver Failure (Liver Disease).CTRI/2018/04/012995Institute of liver and Biliary Sciences90
已完成
1 期
Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected AdultsHIV InfectionsNCT00141024National Institute of Allergy and Infectious Diseases (NIAID)84
撤回
2 期
Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African AdultsHIV InfectionsNCT00415649National Institute of Allergy and Infectious Diseases (NIAID)
已完成
4 期
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A VaccinesHepatitis ANCT02601040Jiangsu Province Centers for Disease Control and Prevention13,500