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18 Diseases |  |
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0 Trials |  |
57 News |  |
- daplusiran/tomligisiran (GSK5637608) / GSK, ARC-520 / Arrowhead
Long-term hepatitis B surface antigen response after finite treatment with siRNAs ARC-520 or JNJ-3989 (Gold Room) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1334;
P1/2, P2
siRNA treatment suppressed HBsAg expression with a prolonged effect for up to 6 years. The siRNA-100 score consisting of baseline qHBsAg and log reduction at nadir may be indicative of HBsAg level <100 IU/mL at LFU.
- || ARC-520 / Arrowhead
Clinical, Journal: Long-term serological, virological and histological responses to RNA inhibition by ARC-520 in Chinese chronic hepatitis B patients on entecavir treatment. (Pubmed Central) - May 11, 2022
P2
MD ARC-520 therapy achieved sustained and profound reductions of viral antigens and HBV RNA. HBsAg seroclearance was achievable.
- || ARC-520 / Arrowhead
Review, Journal: RNA Interference Therapy for Chronic Hepatitis B Predicts the Importance of Addressing Viral Integration When Developing Novel Cure Strategies. (Pubmed Central) - Aug 14, 2021
Early clinical testing with the first of these agents in the clinic, ARC-520, demonstrated that rapid and deep reductions in viral proteins, RNA and DNA could be produced with this approach, but also the surprising insight that HBsAg production from incomplete HBV DNA integrated into the host genome appears to play a heretofore unappreciated and important role in maintaining circulating HBsAg, thought to play a fundamental role in preventing host clearance of the virus. Thus, accounting for viral DNA integration in novel HBV treatment approaches may prove to be essential to achieving successful finite therapies of this difficult to treat chronic infection.
- | ARC-520 / Arrowhead
Journal: Understanding the antiviral effects of RNAi-based therapy in HBeAg-positive chronic hepatitis B infection. (Pubmed Central) - Aug 11, 2021
The observed continuous HBV DNA decline is entecavir mediated, the strong but transient HBsAg and HBeAg decays are ARC-520 mediated. The modeling framework may help assess ongoing RNAi drug development for hepatitis B virus infection.
- || ARC-520 / Arrowhead
Clinical, Journal: RNA Interference Therapy with ARC-520 Results in Prolonged HBsAg Response in Patients with Chronic Hepatitis B Infection. (Pubmed Central) - May 7, 2021
ARC-520 was well tolerated, with only two SAEs of pyrexia possibly related to study drug observed. In conclusion, ARC-520 was active in both E-neg and E-pos, NUC experienced HBV patients, but absolute HBsAg reductions were moderate, possibly due to expression of HBsAg from integrated HBV DNA, indicating the need for RNAi therapeutics that can target viral transcripts regardless of origin.
- | Journal, Interview: Overcoming the challenges of RNAi-based therapy: an interview with James Hamilton. (Pubmed Central) - Apr 30, 2019
...In this role, he managed the ARC-520, ARC-521 and ARC-AAT global programs...He earned an MD and MBA at The Ohio State University (USA) and is a licensed physician with board certification in emergency medicine. J Hamilton speaks to Hannah Makin, commissioning editor.
- | ARC-520 / Arrowhead
Enrollment change, Trial termination, Combination therapy: A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Dec 5, 2016
P2, N=58, Terminated, Sponsor: Arrowhead Pharmaceuticals
J Hamilton speaks to Hannah Makin, commissioning editor. N=136 --> 58 | Recruiting --> Terminated; Company decision to discontinue trial
- | ARC-520 / Arrowhead
Trial termination, Combination therapy: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Dec 5, 2016
P2, N=58, Terminated, Sponsor: Arrowhead Pharmaceuticals
N=136 --> 58 | Recruiting --> Terminated; Company decision to discontinue trial Recruiting --> Terminated; Company decision to discontinue trial
- | ARC-520 / Arrowhead
Trial termination, Trial primary completion date, Combination therapy: Monarch: Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (clinicaltrials.gov) - Dec 5, 2016
P2, N=80, Terminated, Sponsor: Arrowhead Pharmaceuticals
Recruiting --> Terminated; Company decision to discontinue trial Recruiting --> Terminated | Trial primary completion date: Dec 2018 --> Feb 2017; Company decision to discontinue trial
- ARC-520 / Arrowhead
Enrollment change, Trial termination, Trial primary completion date, Combination therapy: Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (clinicaltrials.gov) - Dec 5, 2016
P2, N=12, Terminated, Sponsor: Arrowhead Pharmaceuticals
Recruiting --> Terminated | Trial primary completion date: Dec 2018 --> Feb 2017; Company decision to discontinue trial N=50 --> 12 | Recruiting --> Terminated | Trial primary completion date: Dec 2017 --> Feb 2017; Company decision to discontinue trial
- ARC-520 / Arrowhead
Enrollment change, Trial termination, Combination therapy: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Dec 5, 2016
P2, N=32, Terminated, Sponsor: Arrowhead Pharmaceuticals
N=50 --> 12 | Recruiting --> Terminated | Trial primary completion date: Dec 2017 --> Feb 2017; Company decision to discontinue trial N=90 --> 32 | Recruiting --> Terminated; Company decision to discontinue trial
- ARC-520 / Arrowhead
Enrollment change, Trial termination, Trial primary completion date, Combination therapy: Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (clinicaltrials.gov) - Dec 5, 2016
P2, N=4, Terminated, Sponsor: Arrowhead Pharmaceuticals
N=90 --> 32 | Recruiting --> Terminated; Company decision to discontinue trial N=12 --> 4 | Suspended --> Terminated | Trial primary completion date: Feb 2018 --> Feb 2017; Company decision to discontinue trial
- ARC-520 / Arrowhead
Trial suspension, Trial primary completion date, Combination therapy: Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (clinicaltrials.gov) - Nov 22, 2016
P2, N=12, Suspended, Sponsor: Arrowhead Pharmaceuticals
N=12 --> 4 | Suspended --> Terminated | Trial primary completion date: Feb 2018 --> Feb 2017; Company decision to discontinue trial Recruiting --> Suspended | Trial primary completion date: Sep 2017 --> Feb 2018
- || ARC-520 / Arrowhead
Trial primary completion date, Combination therapy: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Nov 7, 2016
P2, N=60, Recruiting, Sponsor: Arrowhead Pharmaceuticals
Recruiting --> Suspended | Trial primary completion date: Sep 2017 --> Feb 2018 Trial primary completion date: Oct 2016 --> Apr 2017
- | ARC-520 / Arrowhead
Trial initiation date, Combination therapy: Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (clinicaltrials.gov) - Nov 7, 2016
P2, N=50, Recruiting, Sponsor: Arrowhead Pharmaceuticals
Trial primary completion date: Oct 2016 --> Apr 2017 Initiation date: Apr 2016 --> Nov 2016
- | ARC-520 / Arrowhead
Trial initiation date, Combination therapy: Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (clinicaltrials.gov) - Sep 30, 2016
P2, N=12, Recruiting, Sponsor: Arrowhead Pharmaceuticals
Initiation date: Apr 2016 --> Nov 2016 Initiation date: May 2015 --> Aug 2015
- | ARC-520 / Arrowhead
Trial completion: A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (clinicaltrials.gov) - Sep 30, 2016
P1, N=40, Completed, Sponsor: Arrowhead Pharmaceuticals
Initiation date: May 2015 --> Aug 2015 Recruiting --> Completed
- ARC-520 / Arrowhead
Trial primary completion date: A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (clinicaltrials.gov) - Jun 9, 2016
P1, N=40, Recruiting, Sponsor: Arrowhead Pharmaceuticals
Recruiting --> Completed Trial primary completion date: May 2016 --> Aug 2016
- ARC-520 / Arrowhead
Enrollment change, Trial primary completion date, Combination therapy: Monarch: Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (clinicaltrials.gov) - Jun 2, 2016
P2, N=96, Recruiting, Sponsor: Arrowhead Pharmaceuticals
Trial primary completion date: May 2016 --> Aug 2016 N=72 --> 96 | Trial primary completion date: Dec 2017 --> Dec 2018
- ARC-520 / Arrowhead
Trial primary completion date, Combination therapy: Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (clinicaltrials.gov) - May 20, 2016
P2, N=12, Recruiting, Sponsor: Arrowhead Pharmaceuticals
N=72 --> 96 | Trial primary completion date: Dec 2017 --> Dec 2018 Trial primary completion date: Apr 2016 --> Sep 2017
- ||| ARC-520 / Arrowhead
Enrollment change, Trial primary completion date, Combination therapy: A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - May 3, 2016
P2, N=136, Recruiting, Sponsor: Arrowhead Pharmaceuticals
Trial primary completion date: Apr 2016 --> Sep 2017 N=58 --> 136 | Trial primary completion date: Aug 2016 --> Dec 2016
- ARC-520 / Arrowhead
Enrollment change: A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (clinicaltrials.gov) - May 2, 2016
P1, N=40, Recruiting, Sponsor: Arrowhead Pharmaceuticals
N=58 --> 136 | Trial primary completion date: Aug 2016 --> Dec 2016 N=22 --> 40
- ARC-520 / Arrowhead
New P2 trial, Combination therapy: Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (clinicaltrials.gov) - Apr 14, 2016
P2, N=50, Recruiting, Sponsor: Arrowhead Pharmaceuticals
- ARC-520 / Arrowhead
Trial primary completion date: A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (clinicaltrials.gov) - Jan 20, 2016
P1, N=22, Recruiting, Sponsor: Arrowhead Research Corporation
N=22 --> 40 Trial primary completion date: Dec 2015 --> Apr 2016
- || ARC-520 / Arrowhead
Trial primary completion date, Combination therapy: A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Jan 18, 2016
P2, N=58, Recruiting, Sponsor: Arrowhead Research Corporation
Trial primary completion date: Dec 2015 --> Apr 2016 Trial primary completion date: Jan 2016 --> Aug 2016
- |||| ARC-520 / Arrowhead
Enrollment open, Combination therapy: Monarch: Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (clinicaltrials.gov) - Dec 17, 2015
P2, N=72, Recruiting, Sponsor: Arrowhead Research Corporation
Trial primary completion date: Jan 2016 --> Aug 2016 Not yet recruiting --> Recruiting
- ||||| ARC-520 / Arrowhead
New P2 trial, Combination therapy: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Nov 14, 2015
P2, N=60, Recruiting, Sponsor: Arrowhead Research Corporation
- ||||| ARC-520 / Arrowhead
New P2 trial, Combination therapy: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Nov 14, 2015
P2, N=90, Recruiting, Sponsor: Arrowhead Research Corporation
- ARC-520 / Arrowhead
Trial primary completion date, Combination therapy: Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (clinicaltrials.gov) - Nov 11, 2015
P2, N=12, Recruiting, Sponsor: Arrowhead Research Corporation
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2015 --> Apr 2016
- ||||| ARC-520 / Arrowhead
New P2 trial, Combination therapy: Monarch: Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (clinicaltrials.gov) - Oct 23, 2015
P2, N=72, Not yet recruiting, Sponsor: Arrowhead Research Corporation
- ARC-520 / Arrowhead
Enrollment open: A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (clinicaltrials.gov) - Sep 26, 2015
P1, N=22, Recruiting, Sponsor: Arrowhead Research Corporation
Trial primary completion date: Oct 2015 --> Apr 2016 Not yet recruiting --> Recruiting
- | ARC-520 / Arrowhead
New P1 trial: A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (clinicaltrials.gov) - Aug 28, 2015
P1, N=22, Not yet recruiting, Sponsor: Arrowhead Research Corporation
- ARC-520 / Arrowhead
Enrollment change, Trial withdrawal: Study of ARC-520 in Patient With Chronic Hepatitis B Virus (clinicaltrials.gov) - Aug 15, 2015
P2, N=0, Withdrawn, Sponsor: Arrowhead Research Corporation
Not yet recruiting --> Recruiting N=60 --> 0 | Recruiting --> Withdrawn
- ||| ARC-520 / Arrowhead
Enrollment change, Trial primary completion date, Combination therapy: A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Jun 26, 2015
P2, N=58, Recruiting, Sponsor: Arrowhead Research Corporation
N=60 --> 0 | Recruiting --> Withdrawn N=16 --> 58 | Trial primary completion date: Dec 2014 --> Jan 2016
- | ARC-520 / Arrowhead
New P2 trial, Combination therapy: Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (clinicaltrials.gov) - May 22, 2015
P2, N=12, Recruiting, Sponsor: Arrowhead Research Corporation
- |||| ARC-520 / Arrowhead
Enrollment open: Study of ARC-520 in Patient With Chronic Hepatitis B Virus (clinicaltrials.gov) - Mar 2, 2015
P2, N=60, Recruiting, Sponsor: Arrowhead Research Corporation
N=16 --> 58 | Trial primary completion date: Dec 2014 --> Jan 2016 Not yet recruiting --> Recruiting
- ||||| ARC-520 / Arrowhead
New P2 trial: Study of ARC-520 in Patient With Chronic Hepatitis B Virus (clinicaltrials.gov) - Jan 28, 2015
P2, N=60, Not yet recruiting, Sponsor: Arrowhead Research Corporation
- ||| ARC-520 / Arrowhead
Trial completion, Trial primary completion date: Safety and Tolerability Study of ARC-520 in Healthy Volunteers (clinicaltrials.gov) - Dec 10, 2014
P1, N=54, Completed, Sponsor: Arrowhead Research Corporation
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial primary completion date: Jun 2014 --> Sep 2014
- | ARC-520 / Arrowhead
Enrollment open, Combination therapy: A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Mar 2, 2014
P2, N=16, Recruiting, Sponsor: Arrowhead Research Corporation
Recruiting --> Completed | Trial primary completion date: Jun 2014 --> Sep 2014 Not yet recruiting --> Recruiting
- | ARC-520 / Arrowhead
New P2 trial, Combination therapy: A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Feb 17, 2014
P2, N=16, Recruiting, Sponsor: Arrowhead Research Corporation
- ARC-520 / Arrowhead
Enrollment open: Safety and Tolerability Study of ARC-520 in Healthy Volunteers (clinicaltrials.gov) - Jul 21, 2013
P1, N=48, Recruiting, Sponsor: Arrowhead Research Corporation
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | ARC-520 / Arrowhead
New P1 trial: Safety and Tolerability Study of ARC-520 in Healthy Volunteers (clinicaltrials.gov) - Jun 5, 2013
P1, N=48, Recruiting, Sponsor: Arrowhead Research Corporation