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NCT04171765 Clinical Trial

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis

Non-alcoholic Steatohepatitis Clinical Trial

— BANFF  

Official title:
A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04171765
Other study ID # GC41033
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 30, 2020
Est. completion date January 23, 2023

Study information
Verified date April 2024
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

Recruitment information / eligibility
Status Terminated
Enrollment 46
Est. completion date January 23, 2023
Est. primary completion date January 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria - Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3 - Hepatic steatosis on MRI (>= 8% average PDFF) prior to randomization Exclusion Criteria - History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C - Weight gain > 10% or loss > 5% within 3 months prior to randomization - History of liver transplantation - Current or history of significant alcohol consumption

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
• BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.

Locations
Country Name City State
Belgium Hospital Erasme Bruxelles
Belgium Antwerp University Hospital Edegem
Belgium Universitair Ziekenhuis Gent Gent
France CHU Hopitaux de Bordeaux CHU Hopitaux De Bordeaux
France Hospices Civils de Lyon Lyon
France CHU de Nice Nice
France Hopital Pitie-Salpetriere APHP Paris
France Hôpital d'Enfants, Service d?onco-hématologie pédiatrique Vandoeuvre
Puerto Rico Fundacion de Investigacion de Diego San Juan
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Universtiario Virgen del Rocio Sevilla
Spain Consorcio Hospital General Universitario de Valencia Valencia
Spain Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica Valencia
Spain Hospital Universitari i Politecnic La Fe; Servicio de Neurología Valencia
United States Pinnacle Clinical Research - Austin Austin Texas
United States Gastroenterology Associates, LLC Baton Rouge Louisiana
United States Walter Reed Army Medical Center Bethesda Maryland
United States Excel Medical Research Boca Raton Florida
United States Texas Digetive Disease Consultants - Austin Cedar Park Texas
United States Arizona Liver Health - Chandler Chandler Arizona
United States Gregory Wiener, MD Chula Vista California
United States Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department Columbus Ohio
United States Avant Research Associates, LLC Crowley Louisiana
United States Cullman Clinical Trials Cullman Alabama
United States Duke Medical Center; Gen Clinic Research Ctr Durham North Carolina
United States Liver Institute at Renaissance Edinburg Texas
United States South Texas Research Institute Edinburg Texas
United States South Denver Gastroenterology Englewood Colorado
United States Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth) Fort Worth Texas
United States Community Cancer Institute (CCI) Fresno California
United States Liver Associates of Texas - Houston Houston Texas
United States Grand Teton Research Group, PLLC Idaho Falls Idaho
United States Kansas City Research Institute, LLC Kansas City Missouri
United States National Research Inst. Los Angeles California
United States Gastrointestinal Specialists of Georgia, PC Marietta Georgia
United States Premier Research Associate, Inc Miami Florida
United States Arkansas Gastroenterology North Little Rock Arkansas
United States Conquest Clinical Research Orange California
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Amici Clinical Research Raritan New Jersey
United States Hunter Holmes McGuire V.A. Medical Center Richmond Virginia
United States Virginia Commonwealth University Richmond Virginia
United States American Research Corporation Inc. San Antonio Texas
United States Clinical Trials of Texas, Inc San Antonio Texas
United States Pinnacle Clinical Research - San Antonio San Antonio Texas
United States Quality Research Inc San Antonio Texas
United States UC San Diego Airway Research and Clinical Trials Center San Diego California
United States Texas Digestive Disease Consultants - San Marcos San Marcos Texas
United States National Research Institute - Panorama City Santa Monica California
United States Covenant Research Sarasota Florida
United States Arizona Liver Health - Tucson Tucson Arizona
United States Orange Grove Family Practice Tucson Arizona
United States Huron Gastroenterology Associates Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Puerto Rico,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader. Week 52
Secondary Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 Baseline, Week 16, Week 52
Secondary Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52 Week 52
Secondary Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52 Week 52
See also
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