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

NCT ID: NCT03420768

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2019-05-28

Brief Summary

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).

Conditions

Hepatic Cirrhosis; Liver Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1 BMS-986263 45mg weekly

Group Type: EXPERIMENTAL

BMS-986263

Intervention Type: DRUG

Administered by intravenous (IV) infusion

Part 1 BMS-986263 90mg weekly

Group Type: EXPERIMENTAL

BMS-986263

Intervention Type: DRUG

Administered by intravenous (IV) infusion

Part 1 Placebo weekly

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Administered by intravenous (IV) infusion

Part 2 BMS-986263 45mg every 2 weeks

Group Type: EXPERIMENTAL

BMS-986263

Intervention Type: DRUG

Administered by intravenous (IV) infusion

Part 2 BMS-986263 90mg every 2 weeks

Group Type: EXPERIMENTAL

BMS-986263

Intervention Type: DRUG

Administered by intravenous (IV) infusion

Part 2 BMS-986263 90mg every 4 weeks

Group Type: EXPERIMENTAL

BMS-986263

Intervention Type: DRUG

Administered by intravenous (IV) infusion

Part 2 Placebo every 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Administered by intravenous (IV) infusion

Interventions

BMS-986263

Administered by intravenous (IV) infusion

Intervention Type: DRUG

Placebo

Administered by intravenous (IV) infusion

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

The Texas Liver Institute

San Antonio, Texas, United States

Countries

United States

References

Lawitz EJ, Shevell DE, Tirucherai GS, Du S, Chen W, Kavita U, Coste A, Poordad F, Karsdal M, Nielsen M, Goodman Z, Charles ED. BMS-986263 in patients with advanced hepatic fibrosis: 36-week results from a randomized, placebo-controlled phase 2 trial. Hepatology. 2022 Apr;75(4):912-923. doi: 10.1002/hep.32181. Epub 2021 Dec 13.

Reference Type: DERIVED

PMID: 34605045 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

IM025-006

Identifier Type: -

Identifier Source: org_study_id