NCT03444675 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Sigurdsson L, Reyes J, Putnam PE, del Rosario JF, Di Lorenzo C, Orenstein SR, Todo S, Kocoshis SA
Endoscopies in pediatric small intestinal transplant recipients: five years experience. Am J Gastroenterol. 1998 Feb;93(2):207-11.
Tabasco-Minguillán J, Weber K, Nelson F, Hutson W, Furukawa H, Abu-Elmagd K, Todo S, Rakela J
Variability in the interpretations of endoscopic findings in patients with intestinal transplantation. Transplant Proc. 1996 Oct;28(5):2775-6.
Varkey J, Stotzer PO, Simrén M, Herlenius G, Oltean M
The endoscopic surveillance of the transplanted small intestine: a single center experience and a proposal for a grading score. Scand J Gastroenterol. 2018 Feb;53(2):134-139. doi: 10.1080/00365521.2017.1411523. Epub 2017 Dec 12.

A Multi-centre, Longitudinal (Cohort) Study in Patients Undergoing Intestinal or Multivisceral Transplantation to Validate Gothenburg Intestinal Transplant Endoscopy Score (GITES) and Evaluate Its Clinical Performance

Details for clinical trial NCT03444675

Clinical trial NCT03444675 - References