Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
University of Alabama at Birmingham
Birmingham, Alabama, United States
Assess the Safety and Tolerability of Volixibat in Participants With ICP
To assess the safety and tolerability of volixibat in participants with ICP on the basis of the following endpoints: Proportion of participants experiencing one or more of the following: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), events of clinical interest (ECIs), and adverse events (AEs) that lead to discontinuation of study drugs. Clinically significant laboratory abnormalities
Time frame: Through to end of treatment, up to 21 weeks
Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (ItchRO)
Adult Itch Reported Outcome (ItchRO) is a 0 to 10 scale with 0 being "no itch" and 10 being "worst possible itch" where participants are responding to the following question "How would you rate the worst itch you experienced over the last 24hrs?"
Time frame: Through to end of treatment, up to 21 weeks
Proportion of Participants Experiencing One or More of Adverse Perinatal Outcomes
Time frame: At least one month after delivery.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale School of Medicine
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The University of Texas Medical Branch - Galveston
Galveston, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Dunedin Hospital
Dunedin, Otago, New Zealand
Christchurch Women's Hospital
Christchurch, New Zealand
Capital & Coast District Health Board, Wellington Regional Hospital
Wellington, New Zealand
...and 10 more locations