A Phase 2 Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety, and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohns Disease. Save

Date Added
February 13th, 2018
PRO Number
Pro00074924
Researcher
Jose Quiros

Silhouette
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

The purpose of this research study is to determine which dose is effective and how the body processes the study drug, vedolizumab in children ages 2-17 who have ulcerative colitis or Crohn's disease.

This phase 2 study includes a 4-week Screening Period, a 22-week
Treatment Period (with last dose at Week 14). Subjects who do not
enter the long term extension study will have an 18-week Follow-up Period starting
from their last dose of study drug and a long-term follow-up safety
survey by telephone 6 months after their last dose of study drug.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-0387
hudsoncm@musc.edu

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease Save

Date Added
February 13th, 2018
PRO Number
Pro00074819
Researcher
Jose Quiros

Silhouette
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

This is a long-term extension study enrolling male and female pediatric subjects with ulcerative colitis (UC) or Crohn's disease (CD) who initiated vedolizumab intravenous (IV) treatment in the phase 2 Study MLN0002-2003 between the ages of 2 and 17 years of age. The study will evaluate the long-term safety of vedolizumab administered by IV infusion in pediatric subjects with UC or CD. The study will also evaluate the effect of long-term vedolizumab IV treatment on the time to major IBD-related events (hospitalizations, surgeries, or procedures), health-related quality-of-life measurements, patterns of growth and development, and exploratory efficacy measures. Up to 80 rollover subjects from Study MLN0002-2003 will participate in this study. Subjects who weigh 30 kg or greater will receive vedolizumab 300 mg (high dose) or 150 mg (low dose) Q8W. Subjects who weight less than 30 kg will receive vedolizumab 200 mg (high dose) or 100 mg (low dose) IV. Patients will receive treatment and perform assessments every 8 weeks for up to 5 years or until the subject withdraws from the study or the sponsor decides to close the study, whichever comes first.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-0387
hudsoncm@musc.edu

Continuity versus Discontinuity for Bowel Injury in Damage Control Laparotomy: A Prospective Multi-Institutional Study Save

Date Added
November 15th, 2017
PRO Number
Pro00072930
Researcher
Brian Thurston
Keywords
Bowel
Summary

To determine the physiologic consequence of bowel discontinuity after damage control laparotomy. To determine the differences in anastamotic dehiscence, abdominal sepsis, and ischemia after damage control laparotomy with bowel discontinuity versus immediate reconstruction.

Institution
Spartanburg
Recruitment Contact
Amy Hamrick
864-706-6929
amyhamrick@srhs.com

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction Save

Date Added
June 16th, 2015
PRO Number
Pro00044409
Researcher
Whitney Graybill

Silhouette
Keywords
Bowel, Cancer
Summary

This study is for patients who have a malignant bowel obstruction and their doctor is not sure if surgery or non-surgical treatment will be better for the condition.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Gene Discoveries in Subjects with Crohn's Disease of African Descent Save

Date Added
September 2nd, 2014
PRO Number
Pro00034427
Researcher
Jose Quiros

Silhouette
Keywords
Bowel, Children's Health, Crohn's Disease, Digestive System, Ethnicity and Disease, Genetics, Minorities, Pediatrics
Summary

A minimum of 1000 AA subjects with IBD will be recruited in the 4 year period; from Emory, Grady and Children's Healthcare of Atlanta. And a total of 2500 patients form the collaborating institutions.

The primary investigative design will be a paired case-control study. This study will be similar to other IRB approved protocols in which DNA, serum, are collected from children and adults with and without IBD for the purpose of genotype analysis.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@musc.edu

Hirschsprung Disease Research Collaborative Save

Date Added
August 7th, 2012
PRO Number
Pro00014680
Researcher
Robert Cina

Silhouette
Keywords
Bowel, Genetics
Summary

Hirschsprung disease (HSCR) is a birth defect resulting from the absence of nerve (ganglion) cells in the gastrointestinal tract. Hirschsprung disease has a population incidence of 1/5000 live births and most often occurs as an isolated condition. However, approximately 30% of HSCR cases are associated with other birth defects such as Down syndrome, deafness, hypopigmentation, and Ondine's curse (Congenital Central Hypoventilation syndrome (CCHS)). Hirschsprung disease is a genetic condition with autosomal dominant, autosomal recessive, and multigenic patterns of inheritance described. While several genes associated with HSCR have been identified, it is expected that additional genes play a role in the disorder. Furthermore, much remains to be understood about the mechanisms of genetic variants involved in the disease and how variants in multiple genes interact to lead to multiigenic forms of HSCR.

The objective of the Hirschsprung Disease Research Collaborative (HDRC) is to build a large collection of data and biological samples of individuals with HSCR by which genetic data can be linked to detailed and accurate phenotypic information about study participants. The goal of the genetic studies carried out with HDRC samples is to identify genes harboring causative HSCR mutations and to better understand the complex inheritance of HSCR in families by whole genome mapping and sequencing studies. Specifically, we intend to ascertain the frequency with which mutations in any human gene lead to familial and isolated forms of HSCR. Further, clinical information will be used to investigate possible genotype ? phenotype correlations and their relationship with medical, surgical and pathological data on patients.

Institution
MUSC
Recruitment Contact
Robert Cina
843-792-3851
cina@musc.edu

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