A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
May 23rd, 2017
PRO Number
Pro00066720
Researcher
Don Rockey
Keywords
Disease Prevention, Drug Studies, Liver, Stage III
Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of a drug called selonsertib in subjects with compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). The primary goal of this study is to evaluate whether selonsertib (SEL) can reverse the liver fibrosis seen in patients with NASH cirrhosis and reduce the potential complications associated with cirrhosis. A secondary goal of this study is to assess the safety and tolerability of the drug, selonsertib, in subjects with NASH cirrhosis. Participation in this study can last up to 260 weeks, which includes an 8-week screening period, a 240-week treatment period, and a 4-week follow-up period, and a telephone follow-up visit 12 weeks after the week 240 visit.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
wulfb@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis Save

Date Added
May 23rd, 2017
PRO Number
Pro00066711
Researcher
Don Rockey
Keywords
Disease Prevention, Drug Studies, Liver, Stage III, Weight Control
Summary

This is a phase 3, randomized, double-blind, placebo controlled study evaluating the safety and efficacy of an investigational drug called selonsertib in subjects with NASH and bridging (F3) fibrosis.
The primary goal of this study is to evaluate whether selonsertib (SEL) can cause fibrosis reversal and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary goal of this study is to assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis. Subjects will be treated for 240 weeks, and participation in the study can last up to 260 weeks, which includes an 8-week screening period, a 240-week treatment period, and a 4-week follow-up period and a telephone follow-up at 12 weeks after the Week 240 Visit.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
wulfb@musc.edu

Pro00040590: Peers Promoting Exercise Adoption and Maintenance among Cancer Survivors Save

Date Added
March 2nd, 2015
PRO Number
Pro00040590
Researcher
Bernardine Pinto
Keywords
Cancer/Breast, Exercise, Stage I, Stage II, Stage III
Summary

Exercise adoption enhances well-being and recovery from breast cancer. In two previous studies, we have trained community volunteers with the American Cancer Society to provide exercise counseling for breast cancer survivors and the survivors increased their exercise in the short-term (R01 CA132854). This randomized controlled study examines the effects of three maintenance conditions following the 3-month exercise counseling provided by the community volunteers on exercise participation among breast cancer patients at longer follow-ups.
To begin, all study participants (n=150) will receive a 3-month telephone-based exercise program from Reach to Recovery (RTR) volunteers at the American Cancer Society. This will be followed by three maintenance programs during Months 4-9: Reach Plus (participants will receive exercise logs and feedback reports), Reach Plus Phone (monthly counseling calls from coaches, exercise logs and feedback reports) and 3) Reach Plus Messages (monthly email/text messages, exercise logs and feedback reports).
We will enroll 150 women who have completed treatment for breast cancer and assess their exercise behavior, fatigue, quality of life, and mood at baseline (before the 3 month exercise program), 3, 6, 9 and 12 months. The costs and effectiveness of the three groups will be examined to help guide future dissemination of this peer mentoring approach in community-based organizations to enhance cancer survivorship.

Institution
Palmetto
Recruitment Contact
Bernardine Pinto
803-777-9272
pintob@mailbox.sc.edu

Gabapentin for Relapse Prevention: Alcohol Withdrawal-Brain GABA/Glutamate Effects Save

Date Added
March 4th, 2014
PRO Number
Pro00032587
Researcher
Raymond Anton
Keywords
Alcohol, Brain, Drug Studies, Stage III, Substance Use
Summary

This treatment study is an16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a ?sugar pill?). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

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