Last reviewed · How we verify
NCT03531593
Dose Effect Relationship of MTX and IBD
trial testing Ultrasound Elastography in Inflammatory Bowel Diseases in 64 participants. Completed in 31 May 2018.
31 May 2018
Quick facts
| Lead sponsor | Children's Mercy Hospital Kansas City |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 64 |
| Start date | 1 February 2017 |
| Primary completion | 31 May 2018 |
| Estimated completion | 31 May 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ultrasound Elastography
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Liver Fibroses — all drugs for Liver Fibroses →
- Methotrexate — all drugs for Methotrexate →
Sponsor
Children's Mercy Hospital Kansas City
Who can join
Adults 2 to 22, any sex, with Inflammatory Bowel Diseases or Liver Fibroses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Currently there are no guidelines for monitoring hepatic fibrosis associated with long term MTX use. Routine liver biopsies are not being done as a part of surveillance due to potential complications like bleeding and pneumothorax. Non-invasive markers like gammaglamyltransferase (GGTP), Alkaline Phosphatase (AlkPhos), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are deranged at a late stage and may not be helpful in detecting early fibrosis. The current study will utilize a sensitive, but noninvasive, test to evaluate for hepatic fibrosis. We are attempting to screen for early detection of fibrosis due to MTX before it progresses to irreversible cirrhosis and end-stage liver disease. Based on the results of this pilot study, ultrasound elastography could be used to prospectively study a larger population to establish guidelines for monitoring safety and hepatic complications with MTX. The influence of other co-morbid factors like obesity, alcohol ingestion and smoking is critical to identifying high risk patients who may require closer monitoring. We follow close to 550 patients with IBD. If we presume that at least 20% patients are currently receiving methotrexate, we will be able to recruit enough patients for this pilot study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03531593
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Ultrasound Elastography
Trials testing the same drug.
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- NCT05363735 — Ultrasound Elastography Application in Cesarean Section Scar Defect · withdrawn
- NCT03963999 — Validating Ultrasound Biomarkers for Hepatic Sinusoidal Obstruction Syndrome in Pediatric Hematopoietic Cell Transplant · Phase 4 · withdrawn
- NCT04130048 — Thrombus Elastography in Venous Thrombo-Embolism. · unknown
Other recruiting trials for Inflammatory Bowel Diseases
Currently open trials in the same condition.
- NCT07520747 — A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea · recruiting
- NCT07349472 — Pentoxifylline in Patients With Ulcerative Colitis · Phase 2 · recruiting
- NCT07033208 — Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance · NA · recruiting
- NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
- NCT06453317 — Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis · Phase 2 · recruiting
Other Children's Mercy Hospital Kansas City trials
Trials by the same sponsor.
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- NCT07195032 — Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients · Phase 4 · recruiting
- NCT06834594 — Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome · Phase 4 · recruiting
- NCT06738121 — Cosmetic Outcomes of Umbilical Hernia Incisions · NA · completed
- NCT06520657 — Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03531593 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Mercy Hospital Kansas City
- Last refreshed: 17 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03531593.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing