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

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ClinicalTrials.gov Identifier: NCT03420768
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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).

Condition or disease Intervention/treatment Phase
Hepatic Cirrhosis Liver Fibrosis Drug: BMS-986263 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C
Actual Study Start Date : February 13, 2018
Actual Primary Completion Date : December 10, 2018
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1 BMS-986263 45mg weekly Drug: BMS-986263
Administered by intravenous (IV) infusion

Experimental: Part 1 BMS-986263 90mg weekly Drug: BMS-986263
Administered by intravenous (IV) infusion

Placebo Comparator: Part 1 Placebo weekly Other: Placebo
Administered by intravenous (IV) infusion

Experimental: Part 2 BMS-986263 45mg every 2 weeks Drug: BMS-986263
Administered by intravenous (IV) infusion

Experimental: Part 2 BMS-986263 90mg every 2 weeks Drug: BMS-986263
Administered by intravenous (IV) infusion

Experimental: Part 2 BMS-986263 90mg every 4 weeks Drug: BMS-986263
Administered by intravenous (IV) infusion

Placebo Comparator: Part 2 Placebo every 2 weeks Other: Placebo
Administered by intravenous (IV) infusion




Primary Outcome Measures :
  1. Number of participants with histological improvement in liver fibrosis based on liver biopsy [ Time Frame: Up to 169 days ]

Secondary Outcome Measures :
  1. Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE) [ Time Frame: Up to 169 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420768


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, Texas
The Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric Lawitz, Site 0001    210-253-3426      
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03420768     History of Changes
Other Study ID Numbers: IM025-006
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Liver Cirrhosis
Fibrosis
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Pathologic Processes