EPICS-IV

7 evidence topics · 4 sources

Objective

ALP-normalization objective

“normalization of ALP” (opens the source at this quote in a new tab)

Location and study date

Study design

Randomized, double-blind, placebo-controlled phase 3 design

“A Double-blind, Placebo-controlled, Randomized, Phase 3 Study” (opens the source at this quote in a new tab)

Eligibility criteria

ALP-based eligibility

Criterion	Quoted criterion
Screening ALP	“ALP > ULN to < 1.67xULN”

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 ALP normalization as the primary endpoint

ALP as a prognostic marker

“Combining levels of alkaline phosphatase and bilirubin increased the ability to predict patient survival times.” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment

Population	Estimated participants
Randomized study	“89”

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

This study targets ALP above ULN but below 1.67 times ULN, rather than the higher ALP population in EPICS-III. Planned enrollment is 89 participants. The report contains a study design and eligibility record, but no treatment-effect estimates or observed safety results.