Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/10/2019 |
| Start Date: | March 1, 2014 |
| End Date: | December 31, 2019 |
Open Label Study of the Efficacy and Long Term Safety of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Patients With Progressive Familial Intrahepatic Cholestasis
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis
(PFIC) designed to evaluate the safety and efficacy of LUM001. Efficacy will be assessed by
evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus
associated with PFIC.
(PFIC) designed to evaluate the safety and efficacy of LUM001. Efficacy will be assessed by
evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus
associated with PFIC.
The study is divided into 5 parts: a 4-week dose escalation period, a 4-week stable dosing
period, a 5-week stable dosing period, a 59-week long-term exposure period, and an optional
follow-up treatment period for eligible participants who continue treatment with LUM001.
Participants in the optional follow-up treatment period will continue to receive study drug
until they are eligible to enter another LUM001 study or until LUM001 is available
commercially, whichever occurs first.
period, a 5-week stable dosing period, a 59-week long-term exposure period, and an optional
follow-up treatment period for eligible participants who continue treatment with LUM001.
Participants in the optional follow-up treatment period will continue to receive study drug
until they are eligible to enter another LUM001 study or until LUM001 is available
commercially, whichever occurs first.
We found this trial at
6
sites
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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