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Nucleos(t)ide
Combination Hepatitis B Therapies for Chronic Hepatitis B (Piranga Trial)
Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 weeks
Awards & highlights
Piranga Trial Summary
This trial will test the safety and effectiveness of new hepatitis B treatments in people with mild liver damage. It will compare different combinations of drugs against each other and a control group.
Who is the study for?
This trial is for adults with Chronic Hepatitis B who've been on NUC therapy for at least a year, have low HBV DNA levels, and normal liver enzyme ALT levels. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with heart disease, drug abuse history, significant liver fibrosis/cirrhosis, recent cancer treatments or immunosuppressants.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of new combination therapies (including PD-L1 LNA, PEG-IFN, TLR7 agents) in treating Chronic Hepatitis B compared to a control group. It includes screening up to 8 weeks, treatment up to 48 weeks and follow-up for another 48 weeks.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as flu-like symptoms from PEG-IFN; gastrointestinal issues; fatigue; possible changes in blood counts or liver enzymes due to the various drugs being tested.
Piranga Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) loss at 24 weeks post-EOT (End Of Treatment)
Secondary outcome measures
Change from baseline in quantitative HBsAg, anti-HBs, HBeAg, anti-HBe, anti-HBc, HBcrAg, HBV RNA, and HBV DNA levels over time (IU/mL)
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Anti PD-L1 LNA Antibodies
+13 morePiranga Trial Design
9Treatment groups
Experimental Treatment
Active Control
Group I: siRNA(RO7445482)+ Programmed Death Ligand-1 Locked Nucleic Acid (PD-L1 LNA; RO7191863) + NUC [1]Experimental Treatment3 Interventions
Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 13-24, in addition to their background NUC therapy for the 24-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Group II: siRNA (RO7445482) + TLR7 (RO7020531) + NUCExperimental Treatment3 Interventions
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg QOD) will be administered during Weeks 13-24 and Weeks 37-48 (i.e., 2 treatment cycles of 12 weeks' duration each and 42 doses of RO7020531 for each cycle). At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Group III: siRNA (RO7445482) + Pegylated Interferon (PEG-IFN) + NUCExperimental Treatment3 Interventions
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. PEG-IFN will be administered at a dose of 180 μg once weekly (QW) for 48 weeks. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Group IV: siRNA (RO7445482) + PD-L1 LNA (RO7191863) + NUC [2]Experimental Treatment3 Interventions
Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 25-36, in addition to their background NUC therapy for the 36-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Group V: siRNA (RO7445482) + CpAM (RO7049389) + NUCExperimental Treatment3 Interventions
Participants will receive RO7445482 (Dose 2) and RO7049389 (600 mg QD) in addition to 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 the NUC discontinuation criteria have been met.
Group VI: siRNA (RO7445482) (Dose 2) + NUCExperimental Treatment2 Interventions
Participants will receive RO7445482 (Dose 2) in addition to 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 the NUC discontinuation criteria have been met.
Group VII: Short Interfering Ribonucleic acid (siRNA; RO7445482) (Dose1) + NUCExperimental Treatment2 Interventions
Participants will receive RO7445482 (Dose 1) in addition to 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 the NUC discontinuation criteria have been met.
Group VIII: Core Protein Allosteric Modulator (CpAM; RO7049389) + Toll-like Receptor 7 (TLR7;RO7020531) + NUCExperimental Treatment3 Interventions
Participants will receive RO7049389 (600 mg once daily [QD]) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg once every other day [QOD]) will be administered during Weeks 1-12 and Weeks 25-36. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Group IX: Nucleos(t)ide (NUC) Control ArmActive Control1 Intervention
Participants will continue their background NUC therapy for the 48-week treatment period. At the end of the treatment period, in line with current CHB treatment guidelines, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,774 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have liver cancer.I have been on Hepatitis B medication for at least 12 months.My thyroid condition is not well-managed with medication.I am not pregnant, not breastfeeding, and will use birth control or abstain from sex.I have not had cancer treatment or taken immune system affecting drugs in the last 6 months.You have a history of heavy drinking or drug use within the past year.You have received an experimental treatment for Hepatitis B in the past 6 months.I agree to not have sex or use birth control and not donate sperm for 6 months after treatment.I do not have any major health issues that would prevent me from joining the study.I have a history of severe liver problems.I do not have infections like Hepatitis or HIV.I have taken steroids in the past 3 months.Your body mass index (BMI) falls between 18 and 32 kg/m2.
Research Study Groups:
This trial has the following groups:- Group 1: siRNA(RO7445482)+ Programmed Death Ligand-1 Locked Nucleic Acid (PD-L1 LNA; RO7191863) + NUC [1]
- Group 2: Short Interfering Ribonucleic acid (siRNA; RO7445482) (Dose1) + NUC
- Group 3: siRNA (RO7445482) (Dose 2) + NUC
- Group 4: siRNA (RO7445482) + Pegylated Interferon (PEG-IFN) + NUC
- Group 5: Core Protein Allosteric Modulator (CpAM; RO7049389) + Toll-like Receptor 7 (TLR7;RO7020531) + NUC
- Group 6: Nucleos(t)ide (NUC) Control Arm
- Group 7: siRNA (RO7445482) + CpAM (RO7049389) + NUC
- Group 8: siRNA (RO7445482) + TLR7 (RO7020531) + NUC
- Group 9: siRNA (RO7445482) + PD-L1 LNA (RO7191863) + NUC [2]
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor admit seniors to participate?
"This study is only available to those aged between 18 and 65. Though, there are 26 trials for minors and 242 studies tailored towards the elderly population."
Answered by AI
What applications does PD-L1 LNA (RO7191863) usually serve?
"RO7191863 (PD-L1 LNA) is traditionally administered to those suffering from hepatitis c. Other afflictions that can be treated with this medication include chronic compensated liver disease, and hepatitis b."
Answered by AI
Is there a way for me to participate in this research?
"In order to partipate in this trial, participants must have a chronic hepatitis b infection and fall between 18-65 years of age. Currently, the team is looking for approximately 275 patients."
Answered by AI
Has the FDA granted sanction to PD-L1 LNA (RO7191863) for public use?
"Our team at Power assigned PD-L1 LNA (RO7191863) a safety rating of 2, since this Phase 2 trial has some evidence for its security but no data yet confirming the drug's efficacy."
Answered by AI
Has RO7191863 (PD-L1 LNA) been explored by researchers in other studies?
"Currently, 12 trials involving PD-L1 LNA (RO7191863) are in operation. Of the active studies, 2 have reached Phase 3 status and there are 212 different sites where these experiments can be conducted across Barcelona and New york."
Answered by AI
Is enrollment available for this experiment?
"According to public records on clinicaltrials.gov, this research study is actively recruiting participants with the trial first posted on July 5th 2020 and modified most recently on August 25th 2022."
Answered by AI
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