51. 全身性強皮症 Scleroderma Clinical trials / Disease details


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217

  
3 trials found
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1EUCTR2019-004400-35-NO
(EUCTR)
24/06/202004/03/2020The ReSScue trial. Aiming to Reduce disease-related gastro-intestinal symptoms in patients with Systemic Sclerosis by repeat intestinal infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Phase II, randomized, double-blinded placebo-controlled 12 week study followed by a 14 week blinded extension with open label oral ACHIM capsules.The ReSScue trial. Aiming to Reduce disease-related gastro-intestinal symptoms in patients with Systemic Sclerosis by repeat intestinal infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Phase II, randomized, double-blinded placebo-controlled 12 week study followed by a 14 week blinded extension with open label oral ACHIM capsules. Systemic sclerosis (SSc) is a rare, complex, multi-organ disorder characterized by immune-mediated inflammation, progressive organ fibrosis and vascular pathology leading to small vessel obliteration. Gastrointestinal tract (GIT) affliction occurs in 9/10 SSc patients, involves all parts of the GIT and impairs key GIT functions such as motility, absorption and sphincter control. GIT symptoms impact quality of life in SSc, and severe GIT afflictions are among the leading causes of death in SSc.
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ACHIM capsules
INN or Proposed INN: Sodium chloride solution
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Product Name: ACHIM
INN or Proposed INN: Sodium chloride solution
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Oslo University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2Norway
2NCT03059979
(ClinicalTrials.gov)
January 201725/1/2017The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.Systemic Sclerosis;Raynaud PhenomenaDrug: Methylprednisolone;Other: sodium chlorideRadboud UniversityNULLRecruiting18 YearsN/AAll30Early Phase 1Netherlands
3NCT02551042
(ClinicalTrials.gov)
September 201517/12/2014CSL Behring Sclero XIIIA Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic SclerosisSystemic SclerosisDrug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chlorideUniversity College, LondonCSL BehringRecruiting18 YearsN/ABoth26Phase 2United Kingdom