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- ||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Enrollment closed: REEF-1: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 9, 2020
P2b, N=471, Active, not recruiting, Sponsor: Janssen Sciences Ireland UC
Recruiting --> Active, not recruiting
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
New P2 trial: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Jun 18, 2020
P2, N=80, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion date: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jun 11, 2020
P2b, N=120, Recruiting, Sponsor: Janssen Sciences Ireland UC
Recruiting --> Active, not recruiting Trial completion date: Apr 2022 --> Aug 2022
- JNJ-73763989 / J&J
[VIRTUAL] Short-term treatment with RNA interference therapy, JNJ-3989, results in sustained hepatitis B surface antigen suppression in patients with chronic hepatitis B receiving nucleos(t)ide analogue treatment (Channel 1) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-222;
A ≥1.0 log10 reduction in HBsAg at nadir was achieved in 98% of pts. A subset of pts had sustained suppression of HBsAg ~9 months after the last RNAi dose (mean 1.74); sustained suppression of other viral parameters was also seen.
- JNJ-73763989 / J&J, JNJ-56136379 / J&J, JNJ-3989 / J&J
First clinical experience with RNA interference [RNAi]-based triple combination therapy in chronic hepatitis B (CHB): JNJ-73763989 (JNJ-3989), JNJ-56136379 (JNJ-6379) and a nucleos(t)ide analogue (NA) (Mengwi 3 Room) - Mar 9, 2020 - Abstract #APASL2020APASL_117;
- ||||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
New P2b trial: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Feb 27, 2020
P2b, N=120, Recruiting, Sponsor: Janssen Sciences Ireland UC
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion date: REEF-1: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Feb 19, 2020
P2b, N=450, Recruiting, Sponsor: Janssen Sciences Ireland UC
A subset of pts had sustained suppression of HBsAg ~9 months after the last RNAi dose (mean 1.74); sustained suppression of other viral parameters was also seen. Trial completion date: Nov 2022 --> Feb 2023
- || daplusiran/tomligisiran (GSK5637608) / GSK
Enrollment open: A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989 (clinicaltrials.gov) - Jan 29, 2020
P1, N=48, Recruiting, Sponsor: Janssen Sciences Ireland UC
Trial completion date: Nov 2022 --> Feb 2023 Not yet recruiting --> Recruiting
- || daplusiran/tomligisiran (GSK5637608) / GSK
New P1 trial: A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989 (clinicaltrials.gov) - Dec 22, 2019
P1, N=48, Not yet recruiting, Sponsor: Janssen Sciences Ireland UC
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Enrollment open, Trial completion date: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Nov 27, 2019
P2b, N=120, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Nov 2022 --> Jan 2022
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion date: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Nov 15, 2019
P2b, N=120, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting | Trial completion date: Nov 2022 --> Jan 2022 Trial completion date: Jan 2022 --> Nov 2022
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
New P2b trial: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Oct 16, 2019
P2b, N=120, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- JNJ-73763989 / J&J, JNJ-56136379 / J&J, JNJ-3989 / J&J
FIRST CLINICAL EXPERIENCE WITH RNA INTERFERENCE [RNAi]-BASED TRIPLE COMBINATION THERAPY IN CHRONIC HEPATITIS B (CHB): JNJ-73763989 (JNJ-3989), JNJ-56136379 (JNJ-6379) AND A NUCLEOS(T)IDE ANALOGUE (NA) (Hynes Convention Center, Hall B) - Oct 15, 2019 - Abstract #AASLD2019AASLD_3157;
This is the first study to investigate the safety and efficacy of a triple combination of a RNAi (JNJ-3989), a CAM-N (JNJ-6739) and a NA in CHB pts. This combination was well tolerated and pts achieved robust reductions in HBsAg as well as other measurable viral parameters.
- | daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion: A Study of JNJ-73763989 in Healthy Japanese Adult Participants (clinicaltrials.gov) - Sep 25, 2019
P1, N=25, Completed, Sponsor: Janssen Sciences Ireland UC
This combination was well tolerated and pts achieved robust reductions in HBsAg as well as other measurable viral parameters. Recruiting --> Completed
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Enrollment open: REEF-1: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Aug 14, 2019
P2b, N=450, Recruiting, Sponsor: Janssen Sciences Ireland UC
Recruiting --> Completed Not yet recruiting --> Recruiting
- | daplusiran/tomligisiran (GSK5637608) / GSK
Enrollment open: A Study of JNJ-73763989 in Healthy Japanese Adult Participants (clinicaltrials.gov) - Jul 14, 2019
P1, N=24, Recruiting, Sponsor: Janssen Sciences Ireland UC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || daplusiran/tomligisiran (GSK5637608) / GSK
New P1 trial: A Study of JNJ-73763989 in Healthy Japanese Adult Participants (clinicaltrials.gov) - Jun 30, 2019
P1, N=24, Not yet recruiting, Sponsor: Janssen Sciences Ireland UC
- |||||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
New P2b trial: REEF-1: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jun 11, 2019
P2b, N=450, Not yet recruiting, Sponsor: Janssen Sciences Ireland UC