EPICS-V

7 evidence topics · 2 sources

Objective

Long-term clinical-outcomes objective

“time to the first occurrence of the defined clinical outcome events in participants with PBC” (opens the source at this quote in a new tab)

Location and study date

No evidence found.

Study design

Randomized phase 3b/4 study

“Double Blind, Placebo Controlled” (opens the source at this quote in a new tab)

Eligibility criteria

Cirrhosis and biochemical eligibility

“Has documented evidence of cirrhosis” (opens the source at this quote in a new tab)
“ALP >ULN and TB ≤5 × ULN” (opens the source at this quote in a new tab)

Treatment

Saroglitazar magnesium: oral morning dosing

“1 mg, once daily” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using time to first clinical outcome event as the primary endpoint

Clinical-outcome observation period

“baseline to 48 months” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment

Population	Estimated participants
Long-term randomized study	“386”

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary

The planned study evaluates clinical outcomes over 48 months in a population with cirrhosis. Estimated enrollment is 386 participants. The retrieved evidence does not yet establish an effect on clinical events, and its cirrhotic eligibility population differs from the biochemical-response populations of earlier trials.