51. Scleroderma Clinical trials / Disease details
Clinical trials : 525 / Drugs : 565 - (DrugBank : 148) / Drug target genes : 114 - Drug target pathways : 217
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04300426 (ClinicalTrials.gov) | September 24, 2020 | 25/2/2020 | Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue) | Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week Study | Systemic Sclerosis | Drug: ACHIM as solute (10^9 intestinal microbes/ml) | Oslo University Hospital | South-Eastern Norway Regional Health Authority;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North Norway | Completed | 18 Years | 85 Years | All | 75 | Phase 2 | Norway |
| 2 | EUCTR2019-004400-35-NO (EUCTR) | 24/06/2020 | 04/03/2020 | 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. | 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 Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | Norway |