To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

Intercept Pharmaceuticals

Status and phase: Invitation-only; Phase 3

Conditions: Primary Biliary Cholangitis

Treatments: Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06488911

977-311

Details and patient eligibility

About

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Enrollment: 133 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).

Exclusion criteria

• History or presence of other concomitant liver diseases
• Clinical complications of PBC
• History or presence of hepatic decompensating events
• Current or history of gallbladder disease
• If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

133 participants in 1 patient group

OCA 5 mg + BZF 400 mg SR

Experimental group

Description:

Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.

Treatment:

Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)