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- RG6084 / Roche
PHARMACOKINETIC/ PHARMACODYNAMIC MODELLING OF RG6084 EFFECTS ON HEPATITIS B SURFACE ANTIGEN AND ALANINE TRANSAMINASE TO INFORM PHASE 2 DOSING REGIMEN SELECTION () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1031;
The developed PK and PK/PD model identifies separate exposure-response curves for ALT and HBsAg, and predicts the proportion of subjects that will exceed a defined ALT and HBsAg threshold. The model was successfully utilised in RG6084 Phase 2 dosing regimen selection[1] [2], whereby the chosen regimen is anticipated to meaningfully reduce the ALT liability without overtly impacting the HBsAg response.
- |||| Trial completion, Trial completion date, Trial primary completion date, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Aug 20, 2024
P2, N=281, Completed, Sponsor: Hoffmann-La Roche
The model was successfully utilised in RG6084 Phase 2 dosing regimen selection[1] [2], whereby the chosen regimen is anticipated to meaningfully reduce the ALT liability without overtly impacting the HBsAg response. Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Jul 2024 | Trial primary completion date: Oct 2024 --> Jul 2024
- || Trial completion date, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Jul 10, 2024
P2, N=280, Active, not recruiting, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Jul 2024 | Trial primary completion date: Oct 2024 --> Jul 2024 Trial completion date: Jan 2025 --> Jul 2025
- ||| Enrollment closed, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Jun 29, 2023
P2, N=280, Active, not recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Jan 2025 --> Jul 2025 Recruiting --> Active, not recruiting
- || Trial completion date, Trial primary completion date, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Aug 30, 2022
P2, N=275, Recruiting, Sponsor: Hoffmann-La Roche
Recruiting --> Active, not recruiting Trial completion date: Aug 2023 --> Nov 2024 | Trial primary completion date: Mar 2023 --> May 2024
- ||| Enrollment change, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Feb 11, 2022
P2, N=275, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Aug 2023 --> Nov 2024 | Trial primary completion date: Mar 2023 --> May 2024 N=210 --> 275
- ||| Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Jan 7, 2021
P2, N=210, Recruiting, Sponsor: Hoffmann-La Roche
N=210 --> 275 N=60 --> 210 | Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Dec 2021 --> Mar 2023
- | Trial completion date, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Oct 12, 2020
P2, N=60, Recruiting, Sponsor: Hoffmann-La Roche
N=60 --> 210 | Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Dec 2021 --> Mar 2023 Trial completion date: Jul 2022 --> Mar 2023
- | Trial completion date, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Sep 14, 2020
P2, N=60, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Jul 2022 --> Mar 2023 Trial completion date: Apr 2022 --> Jul 2022
- ||| Enrollment open, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - May 17, 2020
P2, N=60, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Apr 2022 --> Jul 2022 Not yet recruiting --> Recruiting
- |||| New P2 trial, Combination therapy: Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - Jan 12, 2020
P2, N=60, Not yet recruiting, Sponsor: Hoffmann-La Roche