A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)

Conditions

Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC).

Brief summary

Mean change in Adult ItchRO score comparing baseline with the average of the weekly averaged daily itch scores to the end of the double-blind study treatment.

Detailed description

1. Mean change in sBA levels, 2. Mean change in total bilirubin levels, 3. Mean change in ALP levels, 4.Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40) from baseline through end of double blind study treatment, 5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue score from baseline to end of double blind study treatment, 6. Change in PROMIS sleep score from baseline to end of double blind study treatment, 7. Proportion of participants achieving a reduction of ≥ 2 points in the weekly averaged daily Adult ItchRO score from baseline to end of double blind study treatment, 8. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), ECIs, and AEs that lead to discontinuation of study drug, 9. Incidence of clinically relevant laboratory abnormalities

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Interventions

DRUGVolixibat Placebo capsule hard oral use

DRUGvolixibat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean change in Adult ItchRO score comparing baseline with the average of the weekly averaged daily itch scores to the end of the double-blind study treatment.	—

Secondary

Measure	Time frame
1. Mean change in sBA levels, 2. Mean change in total bilirubin levels, 3. Mean change in ALP levels, 4.Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40) from baseline through end of double blind study treatment, 5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue score from baseline to end of double blind study treatment, 6. Change in PROMIS sleep score from baseline to end of double blind study treatment, 7. Proportion of participants achieving a reduction of ≥ 2 points in the weekly averaged daily Adult ItchRO score from baseline to end of double blind study treatment, 8. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), ECIs, and AEs that lead to discontinuation of study drug, 9. Incidence of clinically relevant laboratory abnormalities	—

Measure

Time frame

1. Mean change in sBA levels, 2. Mean change in total bilirubin levels, 3. Mean change in ALP levels, 4.Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40) from baseline through end of double blind study treatment, 5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue score from baseline to end of double blind study treatment, 6. Change in PROMIS sleep score from baseline to end of double blind study treatment, 7. Proportion of participants achieving a reduction of ≥ 2 points in the weekly averaged daily Adult ItchRO score from baseline to end of double blind study treatment, 8. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), ECIs, and AEs that lead to discontinuation of study drug, 9. Incidence of clinically relevant laboratory abnormalities

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Countries

Belgium, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed