ISRCTN14833199已完成2 期
An open-label non-randomised trial designed to evaluate the safety and tolerability of RESP301 alongside standard of care in the treatment of fully sensitive and multidrug-resistant pulmonary tuberculosis
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
- 性别
- All
入选标准
- •Hospitalised patients with:
- •1. Smear, culture or DNA probe-proven pulmonary tuberculosis
- •2. On approved guideline-based treatment (subject to drug sensitivity)
- •3. Age =18 years of age
- •4. Able to give written informed consent
- •5. Able to understand instructions
- •6. Able to operate and maintain nebuliser, as assessed by the Investigator
排除标准
- •1. Concomitant severe respiratory disease such as severe asthma and severe COPD with predicted FEV1 <40%
- •2. Any current or previous condition/circumstance that, in the opinion of the investigator, may put the individual at risk
- •3. Unable to tolerate the use of a nebuliser for approximately 8-10 minutes as required by the study, according to the Investigator’s opinion
- •4. Any unstable, uncontrolled, or severe medical condition that in the opinion of the investigator would make the participant unsuitable for the trial
- •5. Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half-lives, whichever is longer
- •6. Known allergy/hypersensitivity to, or relevant drug-drug interaction with, the study drug/components of the study drug
- •7. History of methaemoglobinaemia
- •8. Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial
- •9. Prescribed nitric oxide donating agents (e.g. nitroprusside, isosorbide dinitrate, isosorbide mononitrate, naproxcinod, molsidomine and linsidomine)
研究者
相似试验
尚未招募
不适用
An open-label, prospective randomized trial to assess the non-inferiority of diuretic effect of tolvaptan as an alternative agent to loop diuretics in chronic heart failure.chronic heart failureJPRN-UMIN000026331Department of Cardio-Renal Medicine and Hypertension, Graduate School of Medical Sciences, Nagoya City University, Japan200
进行中（未招募）
1 期
A clinical trial to evaluate the effect of OTL-200, a gene therapy treatment in patients with Late Juvenile (LJ) Metachromatic Leukodystrophy (MLD)EUCTR2019-002636-82-ITOrchard Therapeutics (Europe) Limited6
进行中（未招募）
1 期
A clinical trial to evaluate the effect of OTL-200, a gene therapy treatment in patients with Late Juvenile (LJ) Metachromatic Leukodystrophy (MLD)Metachromatic Leukodystrophy (MLD) is an autosomal recessive disorder caused by mutationsMedDRA version: 20.0Level: PTClassification code: 10067609Term: Metachromatic leukodystrophy Class: 100000004850CTIS2024-511971-13-00Orchard Therapeutics (Europe) Limited6
进行中（未招募）
1 期
An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trialSporadic Inclusion Body Myositis (sIBM)MedDRA version: 21.1Level: LLTClassification code 10075052Term: Sporadic inclusion body myositisSystem Organ Class: 100000004859EUCTR2019-000749-11-GBOrphazyme A/S130
已完成
不适用
An open-label, randomized, controlled trial to assess the efficacy and safety of teprenone in chronic hepatitis C patients concurrent with chronic gastritis treated with peginterferon alpha-2b plus ribavirin.Chronic hepatitis C patients with genotype 1 and high viral load (>= 5 Log IU/mL) concurrent with chronic gastritis.JPRN-UMIN000001391Department of Gastroenterology and Hepatology, Okayama University Hospital200