Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis (CAMEO)
|ClinicalTrials.gov Identifier: NCT02061540|
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Sclerosing Cholangitis (PSC)||Drug: LUM001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Sclerosing Cholangitis|
|Study Start Date :||March 2014|
|Primary Completion Date :||February 2016|
|Study Completion Date :||February 2016|
LUM001 administered orally once each day
LUM001 oral dose
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration until Week 18 ]An Adverse Event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. TEAEs were AEs with a start date on or after the first dose of investigational product and started prior to the last dose of investigational product plus 14 days.
- Change From Baseline in Fasting Serum Bile Acid Level at Week 14 [ Time Frame: Baseline, Week 14 ]Serum bile acid levels were evaluated using blood samples collected.
- Change From Baseline in Liver Enzyme Levels in Serum [ Time Frame: Baseline, Week 14 ]Levels of liver enzymes such as Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in serum were evaluated.
- Change From Baseline in Bilirubin Levels at Week 14 [ Time Frame: Baseline, Week 14 ]Total Bilirubin and Direct (Conjugated) Bilirubin levels were evaluated.
- Change From Baseline in Pruritus as Measured by Adult Itch Reported Outcome (ItchRO) Weekly Sum Score [ Time Frame: Baseline, Week 14 ]The Adult ItchRO instrument was completed twice daily using an electronic diary (eDiary). Each morning and evening score had a range from 0-10, with the higher score indicating increasing itch severity. The following was used for assessing the Adult ItchRO daily score: The score which represented the most severe itching for the day (morning or evening) was taken for each day as the daily score (maximum daily score of 10); If only 1 of the 2 scores was available for the day, the score that was available was used as the daily score; If both the morning and the evening scores were missing, the score was considered missing for the day.
- Change From Baseline for Other Biochemical Markers of Cholestasis: Total Cholesterol, Low Density Lipoprotein Cholesterol [ Time Frame: Baseline, Week 14 ]Total cholesterol (TC) level and low density lipoprotein cholesterol (LDLC) level were considered as biochemical markers of cholestasis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061540
|United States, California|
|: La Jolla, California, United States, 92037|
|University of California at Davis|
|Sacramento, California, United States, 95817|
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|University of Calgary Liver Unit|
|Calgary, Alberta, Canada, T2N 4Z6|
|University Health Network, Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|University of Birmingham|
|Birmingham, England, United Kingdom, B15 2TT|
|Royal Free Hospital|
|London, United Kingdom, NW3 2QG|
|Study Director:||Shire Study Physican||Shire|