The IMAGINE-II study was a multicenter, extension study of LUM001 in children diagnosed with Alagille syndrome (ALGS) who had completed participation in a core LUM001 treatment protocol (ITCH study). Efficacy was assessed by evaluating the effect of LUM001 on the biochemical markers and pruritus associated with ALGS.
Note: If requesting access to IMAGINE-II data, it is recommended to also request access to the ITCH Study data (https://repository.niddk.nih.gov/studies/itch/) as IMAGINE-II is an extension study of ITCH.
The primary objective of IMAGINE-II was to evaluate long-term safety and tolerability of LUM001.
The primary outcome measure of IMAGINE-II was the change from LUM001 Baseline to Week 48 in fasting serum bile acid (sBA). Secondary outcome measures were changes from LUM001 Baseline to Week 216 in biochemical markers of cholestasis and liver disease, pruritus, xanthomas, clinician scratch scale, and sBA.
Inclusion criteria:
Detailed inclusion and exclusion criteria can be found in the study protocol.
The IMAGINE-II study was not analyzed and reported separately. It was anticipated the results would be integrated with the ITCH study. A pooled analysis of the US- and Canadian-based ITCH randomized placebo-controlled trial and its extension study IMAGINE-II of LUM001 and the UK-based IMAGO randomized placebo-controlled trial and its extension study IMAGINE was reported since the structure of the US/Canadian-based and UK-based studies were comparable.
Multidisciplinary Research, Digestive Diseases, Liver Disease
Interventional
2013-12
2020-06
Alagille Syndrome, Cholestasis
Alagille Syndrome (ALGS), LUM001, Fasting Serum Bile Acid (sBA), Biochemical Markers, Marakixibat (MRX), Cholestasis
DDN
Document Name | Description | Document Type | File Format |
---|---|---|---|
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
---|---|---|---|---|