Clinical trial NCT04171765: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
timeFrame: Baseline, Week 16, Week 52
measure: Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52
timeFrame: Week 52
measure: 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
timeFrame: Week 52
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Chandler
country: United States
facility: Arizona Liver Health - Chandler
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Health - Tucson
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Chula Vista
country: United States
facility: Gregory Wiener, MD
state: California
city: Fresno
country: United States
facility: Community Cancer Institute (CCI)
state: California
city: Los Angeles
country: United States
facility: National Research Inst.
state: California
city: Orange
country: United States
facility: Conquest Clinical Research
state: California
city: San Diego
country: United States
facility: UC San Diego Airway Research and Clinical Trials Center
state: California
city: Santa Monica
country: United States
facility: National Research Institute - Panorama City
state: California
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Boca Raton
country: United States
facility: Excel Medical Research
state: Florida
city: Miami
country: United States
facility: Premier Research Associate, Inc
state: Florida
city: Sarasota
country: United States
facility: Covenant Research
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLLC
state: Idaho
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Crowley
country: United States
facility: Avant Research Associates, LLC
state: Louisiana
city: Bethesda
country: United States
facility: Walter Reed Army Medical Center
state: Maryland
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Research Institute, LLC
state: Missouri
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Durham
country: United States
facility: Duke Medical Center; Gen Clinic Research Ctr
state: North Carolina
city: Columbus
country: United States
facility: Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Pinnacle Clinical Research - Austin
state: Texas
city: Cedar Park
country: United States
facility: Texas Digetive Disease Consultants - Austin
state: Texas
city: Edinburg
country: United States
facility: Liver Institute at Renaissance
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute
state: Texas
city: Fort Worth
country: United States
facility: Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas - Houston
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research - San Antonio
state: Texas
city: San Marcos
country: United States
facility: Texas Digestive Disease Consultants - San Marcos
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire V.A. Medical Center
state: Virginia
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: CHU Hopitaux De Bordeaux
country: France
facility: CHU Hopitaux de Bordeaux
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hopital Pitie-Salpetriere APHP
city: Vandoeuvre
country: France
facility: Hôpital d'Enfants, Service d?onco-hématologie pédiatrique
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universtiario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: