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A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531

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ClinicalTrials.gov Identifier: NCT02956850
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic hepatitis B. Part I will be conducted in two portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include only healthy volunteers. Part II will commence after completion of the MAD portion of Part I and will include only Chronic Hepatitis B (CHB) participants.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Other: Placebo Drug: RO7020531 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Multi-Center, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of RO7020531: (1). Single and Multiple Ascending Doses in Healthy Male and Female Subjects; (2). 6-Week Treatment of Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : November 23, 2019
Estimated Study Completion Date : May 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part I: SAD in Healthy Volunteers
Healthy volunteers will receive single dose of RO7020531 or matching placebo orally on Day 1 of each cohort. A planned dose-escalation sequence for SAD is 3 milligrams (mg), 10 mg, 20 mg, 40 mg, 60 mg, 100 mg, 140 mg, and 170 mg.
Other: Placebo
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.

Drug: RO7020531
RO7020531 will be administered as per schedule specified in the respective arm.

Experimental: Part I: MAD in Healthy Volunteers
Healthy volunteers will receive RO7020531 (dose as selected based on safety, PK and PD data of SAD cohorts) or matching placebo orally every other day (QOD) from Day 1 through to Day 13.
Other: Placebo
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.

Drug: RO7020531
RO7020531 will be administered as per schedule specified in the respective arm.

Experimental: Part II: CHB Participants
CHB participants will receive RO7020531 (dose as selected based on safety, PK and PD data of MAD cohorts) or matching placebo orally QOD from Day 1 through to Day 41.
Other: Placebo
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.

Drug: RO7020531
RO7020531 will be administered as per schedule specified in the respective arm.




Primary Outcome Measures :
  1. Part I: Percentage of Participants With Adverse Events [ Time Frame: From randomization up to Day 41 ]
  2. Part II: Percentage of Participants With Adverse Events [ Time Frame: From randomization up to Week 12 ]

Secondary Outcome Measures :
  1. Part I: Maximum Observed Plasma Concentration (Cmax) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: SAD:Predose(0-2 hours [hrs] before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD:Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Day 1,13; Predose(0-2 hrs before dose),2,6,24 hrs postdose on Day 3,5,7,9,11 ]
  2. Part II: Cmax of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21 ]
  3. Part I: Time to Reach Cmax (Tmax) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11 ]
  4. Part II: Tmax of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21 ]
  5. Part I: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11 ]
  6. Part II: AUCinf of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21 ]
  7. Part I: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11 ]
  8. Part II: AUClast of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21 ]
  9. Part I: Half-Life (t1/2) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805 [ Time Frame: SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11 ]
  10. Part II: t1/2 of RO7020531; and its Metabolites including RO7011785, RO7018822 and RO7033805 [ Time Frame: Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21 ]
  11. Part I: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine [ Time Frame: 0 to 24 hrs post-dose on Day 1 ]
  12. Part I and II: Pharmacodynamics: Plasma Neopterin Levels [ Time Frame: SAD: Days 1, 2, 3, 5, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  13. Part I and II: Pharmacodynamics: Plasma Interferon (INF)-alpha Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  14. Part I and II: Pharmacodynamics: Plasma Interferon Gamma-Inducible Protein 10 (IP-10) Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  15. Part I and II: Pharmacodynamics: Plasma Tumor Necrosis Factor (TNF)-alpha Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  16. Part I and II: Pharmacodynamics: Plasma IL-6 Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  17. Part I and II: Pharmacodynamics: Plasma IL-10 Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  18. Part I and II: Pharmacodynamics: Plasma IL-12p40 Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  19. Part I and II: Pharmacodynamics: Plasma Interferon-Stimulated Gene (ISG) 15 messenger Ribonucleic Acid (mRNA) Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  20. Part I and II: Pharmacodynamics: Plasma Oligoadenylate Synthetase (OAS)-1 mRNA Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  21. Part I and II: Pharmacodynamics: Plasma Myxovirus Resistance 1 gene (MX1) mRNA Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  22. Part I and II: Pharmacodynamics: Plasma Toll-Like Receptor (TLR) 7 mRNA Levels [ Time Frame: SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description) ]
    SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41

  23. Part II: Percentage of T-Cells [ Time Frame: Predose (0-2 hrs before dose) on Day 21; 24 hrs postdose on Day 41; Week 9 and Week 12 ]
  24. Part II: Percentage of B-Cells [ Time Frame: Predose (0-2 hrs before dose) on Day 21; 24 hrs postdose on Day 41; Week 9 and Week 12 ]
  25. Part II: Percentage of NK Cells [ Time Frame: Predose (0-2 hrs before dose) on Day 21; 24 hrs postdose on Day 41; Week 9 and Week 12 ]
  26. Part II: Percentage of Myeloid Cells [ Time Frame: Predose (0-2 hrs before dose) on Day 21; 24 hrs postdose on Day 41; Week 9 and Week 12 ]
  27. Part II: Percentage of Plasmacytoid Dendritic Cells (pDCs) [ Time Frame: Predose (0-2 hrs before dose) on Day 21; 24 hrs postdose on Day 41; Week 9 and Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Part 1: SAD and MAD in Healthy Volunteers

  • A Body Mass Index (BMI) between 18 to 32 kilograms per square meter (kg/m^2), inclusive
  • Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing product) per day
  • Negative Anti-Nuclear Antibody (ANA) test; or positive with dilutions not greater than 1:40 and with no associated history or symptoms of potential connective tissue disease or other immune-mediated diseases

Part 2: CHB Participants

  • A BMI between 18 to 32 kg/m^2, inclusive
  • CHB infection (positive test for Hepatitis B surface antigen [HBsAg] for more than 6 months prior to randomization)
  • For Cohort 1, 2, 3 and 4: HBsAg detectable at screening
  • For Cohort 1, 2 and 3: HBV DNA < 90 IU/mL for at least 6 months prior to randomization; HBV DNA < 90 IU/mL at screening by Roche Cobas assay
  • For Cohort 4: HBV DNA at screening >= 2 × 10*4 IU/mL for HBeAg positive and >= 2 x 103 IU/mL for HBeAg negative patients
  • For Cohort 1, 2 and 3: Alanine amino transferase (ALT) =<1.5 × upper limit of normal (ULN) during the 6 months prior to randomization confirmed by two measurements separated by at least 14 days; ALT at screening =< 1.5 × ULN.
  • For Cohort 4: ALT and aspartate aminotransferase (AST) at screening and Day -1 visit: =< 5 × ULN.
  • Negative ANA test; or positive with dilutions not greater than 1:40 and with no associated history or symptoms of potential connective tissue disease or other immune-mediated diseases
  • Liver biopsy, Fibroscan® or equivalent elastography test obtained within 6 months prior to randomization demonstrating liver disease consistent with chronic HBV infection with absence of cirrhosis and absence of extensive bridging fibrosis (cirrhosis or extensive bridging fibrosis are defined as greater than or equal to (>/=) Metavir 3, recommended cut-off for Fibroscan 8.5 kilopascals [kPa])
  • For Cohort 1, 2 and 3: On treatment with tenofovir, entecavir, adefovir, or telbivudine, either as single agents or in combination, for at least 6 months
  • For Cohort 4: Hepatitis B virus (HBV) treatment naïve or not on any anti-HBV treatment for the past 6 months

Exclusion Criteria:

Part 1: SAD and MAD in Healthy Volunteers

  • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other autoimmune disease); clinically significant psychiatric disease, acute infection (e.g., influenza), gastrointestinal (GI) disease (including inflammatory bowel disease, peptic ulcer disease, GI hemorrhage)
  • History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids, IFN or pegylated interferon [PEG-IFN]) within the 8 weeks prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
  • Positive Hepatitis A virus antibody (HAV Ab IgM), HBsAg, Hepatitis C antibody (HCV Ab), or positive for human immunodeficiency virus (HIV) at screening
  • History of clinically significant thyroid disease; also, participants with clinically significant elevated thyroid-stimulating hormone (TSH) concentrations at screening
  • Positive results for anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) or thyroid peroxidase antibody

Part 2: CHB Participants

  • History of liver cirrhosis
  • History or other evidence of bleeding from esophageal varices
  • Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or clinical evidence such as ascites or varices)
  • History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic steato-hepatitis, etc.). A clinical diagnosis of fatty liver is allowed provided that non alcoholic steatohepatitis (NASH) has been excluded by liver biopsy or non-invasive markers
  • Documented history or other evidence of metabolic liver disease within one year of randomization
  • Positive test for Hepatitis A virus (IgM anti-HAV), HCV, Hepatitis D or HIV
  • History of or suspicion of hepatocellular carcinoma or alpha fetoprotein >/=13 nanograms per milliliter (ng/mL) at screening
  • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other autoimmune disease); clinically significant psychiatric disease, acute infection (e.g., influenza), GI disease (including inflammatory bowel disease, peptic ulcer disease, GI hemorrhage)
  • History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids,IFN or PEG-IFN) within the 8 weeks prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Cohort 4: Concurrent HBV treatments
  • History of organ transplantation
  • Clinically significant thyroid disease; also, participants with clinically significant elevated TSH concentrations at screening
  • Positive results for AMA, ASMA or thyroid peroxidase antibody

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): NCT02956850


Contacts
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Contact: Reference Study ID Number: NP39305 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Bulgaria
Gastroenterology department, Second clinic of internal diseases Recruiting
Sofia, Bulgaria, 1407
COMAC Medical; Clinical Research Unit for Phase I Recruiting
Sofia, Bulgaria, 1612
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
The Chinese University of Hong Kong Recruiting
Shatin, Hong Kong, 123456
Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico; U.O. Farmacia Recruiting
Modena, Emilia-Romagna, Italy, 41124
ASST PAPA GIOVANNI XXIII; Epatologia e gastroenterologia pediatrica e dei trapianti Recruiting
Bergamo, Lombardia, Italy, 24127
Medicina Generale ed Epatologia (Humanitas-Rozzano) Recruiting
Rozzano, Lombardia, Italy, 20089
Netherlands
Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center Recruiting
Amsterdam, Netherlands, 1100 DD
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand, 1142
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 407
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70457
Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan, 112
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Thailand
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital Recruiting
Chiang Mai, Thailand, 50200
United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
King College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02956850     History of Changes
Other Study ID Numbers: NP39305
2016-003723-38 ( EudraCT Number )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic