A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatic Cirrhosis; Liver Fibrosis

Treatments: Drug: BMS-986263; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03420768

IM025-006

Details and patient eligibility

About

This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).

Enrollment: 61 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)
• Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)

Exclusion Criteria:

• Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)
• Participants having liver diseases associated with infection with any other hepatitis virus
• Detectable HCV RNA at screening
• Child-Pugh score > 6
• Model for End-Stage Liver Disease score >12
• Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP ≥ 50 and ≤ 100 ng/mL (≥ 41.3 IU/mL and ≤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound
• Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc
• Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 7 patient groups, including a placebo group

Part 1 BMS-986263 45mg weekly

Experimental group

Treatment:

Drug: BMS-986263

Part 1 BMS-986263 90mg weekly

Experimental group

Treatment:

Drug: BMS-986263

Part 1 Placebo weekly

Placebo Comparator group

Treatment:

Other: Placebo

Part 2 BMS-986263 45mg every 2 weeks

Experimental group

Treatment:

Drug: BMS-986263

Part 2 BMS-986263 90mg every 2 weeks

Experimental group

Treatment:

Drug: BMS-986263

Part 2 BMS-986263 90mg every 4 weeks

Experimental group

Treatment:

Drug: BMS-986263

Part 2 Placebo every 2 weeks

Placebo Comparator group

Treatment:

Other: Placebo