Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225715
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Nucleos(t)ide (NUC) Drug: CpAM (RO7049389) Drug: TLR7 (RO7020531) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
Actual Study Start Date : July 5, 2020
Estimated Primary Completion Date : December 18, 2021
Estimated Study Completion Date : March 18, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nucleos(t)ide (NUC) Control Arm
Participants will continue their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless Hepatitis B surface antigen (HBsAg) loss is observed.
Drug: Nucleos(t)ide (NUC)
Nucleos(t)ide (NUC) will be administered orally

Experimental: CpAM (RO7049389) + TLR7 (RO7020531) + NUC
Participants will receive RO7049389 (600 mg QD) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg QOD) will be administered during Weeks 1-12 and Weeks 25-36. At the end of the treatment period, participants will discontinue all study treatments (i.e., CpAM + TLR7 + NUC).
Drug: Nucleos(t)ide (NUC)
Nucleos(t)ide (NUC) will be administered orally

Drug: CpAM (RO7049389)
CpAM (RO7049389) will be administered orally

Drug: TLR7 (RO7020531)
TLR7 (RO7020531) will be administered orally




Primary Outcome Measures :
  1. Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) loss at 24 weeks post-EOT (End Of Treatment) [ Time Frame: Up to 72 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with HBsAg loss [ Time Frame: Up to 96 weeks ]
  2. Percentage of Participants with HBsAg seroconversion [ Time Frame: Up to 96 weeks ]
  3. Percentage of Participants with Hepatitis B Early Antigen (HBeAg) loss (baseline HBeAg-positive participants). [ Time Frame: Up to 96 weeks ]
  4. Percentage of Participants with HBeAg seroconversion (baseline HBeAgpositive participants) [ Time Frame: Up to 96 weeks ]
  5. Percentage of Participants with HBV DNA < lower limit of quantification (LLOQ), <200 IU/mL and <2,000 IU/mL [ Time Frame: Up to 96 weeks ]
  6. Change from baseline in quantitative HBsAg, anti-HBs, HBeAg, anti-HBe, HBcrAg, HBV RNA, and HBV DNA levels over time (IU/mL) [ Time Frame: Up to 96 weeks ]
  7. Plasma Pharmacokinetics (PK) (TLR7) (IU/mL) [ Time Frame: Up to 48 weeks ]
  8. Plasma PK (CpAM) (IU/mL) [ Time Frame: Up to 48 weeks ]
  9. Plasma PK (NUC) (IU/mL) [ Time Frame: Up to 48 weeks ]
  10. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 96 weeks ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index between 18 and 32 kg/m2 inclusive.
  • Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for >=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for >=12 months, having received the same NUC therapy for >=3 months prior to screening.
  • HBV DNA below the lower LLOQ or < 20 IU/mL for > 6 months prior to screening and confirmed at screening.
  • Alanine transaminase (ALT) <=2 x upper limit of normal (ULN) for > 6 months prior to screening and confirmed at screening.
  • Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
  • Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Co-infection with Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV).
  • History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease.
  • History of or suspicion of Hepatocellular Carcinoma (HCC).
  • Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests.
  • Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study.
  • Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study.
  • Electrocardiogram (ECG) with clinically significant abnormalities.
  • Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.

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): NCT04225715


Contacts
Layout table for location contacts
Contact: Reference Study ID: WV41073 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04225715    
Other Study ID Numbers: WV41073
2019-002086-35 ( EudraCT Number )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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