Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.

This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

Study Overview

• Status: Terminated
• Conditions: Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Placebo; Drug: CC-90001

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • University of Sydney - Royal Prince Alfred Hospital
    • Kingswood, New South Wales, Australia, 2751
      • Nepean Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women'S Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Hospital Brisbane
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary, Cumming School of Medicine
    • Edmonton, Alberta, Canada, T6L 6K3
      • South Edmonton Gastroenterology
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto Center for Liver Disease - Francis Family Liver Clinic
• France
  • Angers, France, 49033
    • CHU d'Angers
  • Clichy cedex, France, 92110
    • Assistance Publique - Hopitaux de Paris - Hopital Beaujon
  • Lyon, France, 69317
    • Hôpital de la Croix-Rousse
  • Paris, France, 75014
    • Assistance Publique - Hôpitaux de Paris - Hôpital COCHIN
  • Paris CEDEX 13, France, 75651
    • Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
  • Pessac Cedex, France, 33604
    • Hopital Haut Leveque
  • Rennes cedex 09, France, 35033
    • Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou
  • Strasbourg, France, 67098
    • Hôpital Hautepierre
  • Strasbourg, France, 67098
    • Local Institution - 356
• Germany
  • Aachen, Germany, 52074
    • Universitaetsklinikum der RWTH Aachen
  • Frankfurt am Main, Germany, 60590
    • Johann Wolfgang Goethe University Hospital
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
• Japan
  • Hamamatsu, Japan, 431-3192
    • Hamamatsu University Hospital
  • Hamamatsu, Japan, 431-3192
    • Local Institution - 604
  • Kashihara, Japan, 634-8522
    • Nara Medical University Hospital
  • Kashihara, Japan, 634-8522
    • Local Institution - 608
  • Kawasaki, Japan, 215-0026
    • Shin-yurigaoka General Hospital
  • Kawasaki, Japan, 215-0026
    • Local Institution - 601
  • Kurume, Fukuoka, Japan, 830-0011
    • Kurume University Hospital
  • Kurume, Fukuoka, Japan, 830-0011
    • Local Institution - 607
  • Kyoto-City, Japan, 602-8566
    • University Hospital, Kyoto Prefectural University of Medicine
  • Kyoto-City, Japan, 602-8566
    • Local Institution - 615
  • Musashino, Japan, 180-8610
    • Japanese Red Cross Musashino Hospital
  • Musashino, Japan, 180-8610
    • Local Institution - 602
  • Nagakute, Japan, 480-1195
    • Aichi Medical University Hospital
  • Nagakute, Japan, 480-1195
    • Local Institution - 611
  • Ogaki, Japan, 503-8502
    • Ogaki Municipal Hospital
  • Ogaki, Japan, 503-8502
    • Local Institution - 613
  • Osaka-Fu, Japan, 565-0871
    • Osaka University Hospital OUH
  • Osaka-Fu, Japan, 565-0871
    • Local Institution - 603
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Saga, Japan, 849-8501
    • Local Institution - 609
  • Sakai-shi, Japan, 599-8247
    • Belland General Hospital
  • Sakai-shi, Japan, 599-8247
    • Local Institution - 605
  • Suita, Japan, 564-0013
    • Saiseikai Suita Hospital
  • Suita, Japan, 564-0013
    • Local Institution - 612
  • Yokohama, Kanagawa, Japan, 213-8507
    • Yokohama City University Hospital
  • Yokohama, Kanagawa, Japan, 213-8507
    • Local Institution - 600
• Korea, Republic of
  • Bucheon-si, Korea, Republic of, 420-853
    • Soon Chun Hyang University Hospital Bucheon
  • Seoul, Korea, Republic of, 3080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 5505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of, 156-707
    • Boramae Medical Center
  • Seoul, Korea, Republic of, 152-703
    • Korea University Hospital at Guro
  • Wonju-si, Korea, Republic of, 26426
    • Yonsei University Wonju Severance Christian Hospital
• Poland
  • Katowice, Poland, 40-040
    • Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • Katowice, Poland, 40-752
    • Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego
  • Krakow, Poland, 31-501
    • Krakow Medical Center LLC
  • Lodz, Poland, 90-127
    • Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi
  • Lodz, Poland, 91-347
    • Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego
  • Myslowice, Poland, 41-400
    • ID Clinic
  • Myslowice, Poland, 41-400
    • Local Institution - 453
  • Warszawa, Poland, 01-192
    • Synexus SCM Sp. z o.o. Oddz. Warszawa
• Spain
  • Barcelona, Spain, 08035
    • Hospital Val d'Hebron
  • Girona, Spain, 17007
    • University Hospital of Girona Dr. Josep Trueta
  • Sabadell (Barcelona), Spain, 08208
    • Parc Tauli Hospital Universitari
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
• United Kingdom
  • Birmingham, United Kingdom, B15 2TT
    • University of Birmingham Institute of Biomedical Research
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
  • Hardwick, United Kingdom, TS19 8PE
    • North Tees (DRS) Synexus North Teesside Clinical Research Centre
  • Hardwick, United Kingdom, TS19 8PE
    • Local Institution - 558
  • Hexham, United Kingdom, NE46 1QJ
    • Synexus Hexham Clinical Research Centre, Hexham (DRS)
  • Hexham, United Kingdom, NE46 1QJ
    • Local Institution - 556
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)
  • London, United Kingdom, W2 1NY
    • Imperial College University Trust
  • London, United Kingdom, W2 1NY
    • Local Institution - 559
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Phoenix
    • Phoenix, Arizona, United States, 85013
      • Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute
  • California
    • La Jolla, California, United States, 92093-0960
      • UC San Diego School of Medicine
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Comprehensive Transplant Center
    • Pasadena, California, United States, 91105
      • California Liver Research Institute
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Clemente, California, United States, 92673
      • Southern California GI & Liver Centers
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, School of Medicine - Hepatology Clinic - Anschutz
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
    • Englewood, Colorado, United States, 80113
      • South Denver Gastroenterology
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale Cancer Center
  • Florida
    • Lakewood Ranch, Florida, United States, 34202-2719
      • Florida Digestive Health Specialists
    • Lakewood Ranch, Florida, United States, 34202-2719
      • Local Institution - 176
    • Miami, Florida, United States, 33136
      • University of Miami Schiff Center for Liver Diseases
    • Palmetto Bay, Florida, United States, 33157
      • IMIC, Inc.
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia, PC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center - University Cardiovascular Surgeons
  • Kansas
    • Shawnee Mission, Kansas, United States, 66217
      • WestGlen Gastrointestinal Consultants, P.A.
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • The Institute for Digestive Health & Liver Disease at Mercy Medical Center
    • Catonsville, Maryland, United States, 21228
      • Digestive Disease Associates, PA
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconness Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110-0250
      • Saint Louis University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • University of Nebraska
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10016
      • Concorde Medical Group
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital - Weill-Cornell
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals GI Medicine Clinic
    • Chapel Hill, North Carolina, United States, 27514
      • Local Institution - 102
    • Durham, North Carolina, United States, 27710
      • Duke University School of Medicine
    • Huntersville, North Carolina, United States, 28078
      • Carolinas HealthCare System Digestive Health
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center - Center for Liver Diseases
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • University Gastroenterology
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch LLC
    • Germantown, Tennessee, United States, 38138
      • Gastro One
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute LLC
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75203
      • Liver Institute at Methodist Dallas
    • Fort Sam Houston, Texas, United States, 78235-8200
      • Brooke Army Medical Center Francis Street Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Baylor Heart Clinic
    • Rockwell, Texas, United States, 75032
      • Digestive Health Associates of Texas (DHAT)
    • San Antonio, Texas, United States, 78215
      • American Research Corporation
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center Gastro
  • Virginia
    • Newport News, Virginia, United States, 23603
      • Bon Secours Liver Institute of Hampton Roads
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
    • Richmond, Virginia, United States, 23226
      • Bon Secours Liver Institute of Richmond
    • Richmond, Virginia, United States, 23249
      • McGuire Veterans Affairs Medical Center
    • Richmond, Virginia, United States, 23298-0341
      • Virginia Commonwealth University School of Medicine
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Harborview Medical Center
    • Seattle, Washington, United States, 98105
      • Liver Institute Northwest PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 2, Stage 3 fibrosis based of the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher

Exclusion Criteria:

- Key Exclusion Criteria

1. History or evidence of decompensated liver disease,
2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
3. Participant has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening.
4. History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency [CVID]).
5. History of hepatitis B and/or hepatitis C.
6. History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
7. Pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CC-90001 400 mg once daily (QD); CC-90001 400 mg QD	Drug: CC-90001; oral
Experimental: CC-90001 200 mg once daily; CC-90001 200 mg QD	Drug: CC-90001; oral
Experimental: CC-90001 100 mg once daily; CC-90001 100 mg QD	Drug: CC-90001; oral
Placebo Comparator: Placebo once daily; Placebo QD	Drug: Placebo; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52	Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4); Stage 0 - None;; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis;; Stage 1c - Portal/periportal fibrosis only;; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis;; Stage 3 - Bridging fibrosis;; Stage 4 - Cirrhosis.	From baseline up to week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52	Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4); Stage 0 - None;; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis;; Stage 1c - Portal/periportal fibrosis only;; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis;; Stage 3 - Bridging fibrosis;; Stage 4 - Cirrhosis.	From baseline up to week 52
Percentage of Participants With Improvement in Total NAS	Percentage of participants with an improvement of ≥ 2 points in the total NAS with improvement in more than one category of steatosis, lobular inflammation, and hepatocellular ballooning, and no worsening of liver fibrosis at Week 52. A participant with a change of ≤ -2 from baseline in total NAS, a change of ≤ -1 from baseline in more than one subscore, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.	From baseline up to week 52
Percentage of Participants With Resolution of NASH	Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 at Week 52. Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation is considered as a responder for this endpoint.	From baseline up to week 52
Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis	Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 and no worsening of liver fibrosis at Week 52 Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.	From baseline up to week 52
Percentage of Participants Who Progressed to Cirrhosis	Percentage of participants who progressed to cirrhosis	From baseline up to week 52
Mean Change From Baseline in Liver Biochemistry	Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT)	From baseline up to week 52
Mean Change From Baseline in Metabolic Parameters	Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides	From baseline up to week 52
Cmax	Cmax is defined as maximum plasma concentration of the drug	Day 1 and at Week 4
Tmax	Tmax is defined is the time to maximum plasma concentration	Day 1 and at Week 4
AUC (0-t)	Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration	Day 1 and at Week 4
AUC t	Area under the plasma concentration time-curve. AUC over the dosing interval.	Day 1 and at Week 4
Apparent Total Body Clearance of the Drug	Apparent total body clearance of the drug (CL/F)	At Week 4
Number of Participants With Treatment Related Safety Events	Number of participants with treatment related safety events	From baseline up to week 52
Mean Change From Baseline of ECG Results - PR Intervals	Mean change from baseline in PR interval PR Interval: Atrial depolarization and conduction through the AV node Normal Range: 0.12 - 0.20 (120 to 200 msec)	From baseline up to week 52
Mean Change From Baseline of ECG Results - QRS Duration	Mean change from baseline in QRS duration QRS Duration: Ventricular depolarization and atrial repolarization Normal Range: 0.08 to 0.10 (80 to 100 msec)	From baseline up to week 52
Mean Change From Baseline of ECG Results - QT Interval	Mean change from baseline in QT interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec	From baseline up to week 52
Mean Change From Baseline of ECG Results - QTcB Interval	Mean change from baseline in QTcB interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula. QTc = QT/√(RR) RR= Respiration Rate	From baseline up to week 52
Mean Change From Baseline of ECG Results - QTcF Interval	Mean change from baseline in QTcF interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate	From baseline up to week 52

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): September 28, 2021

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: NASH; Non-Alcoholic Steatohepatitis; CC-90001; Liver Fibrosis; Non-Alcoholic Fatty Liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CC-90001-NASH-001; U1111-1235-3234 (Other Identifier: WHO); 2018-004431-79 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No