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GSK plc today announced promising interim results from the B-Clear phase IIb trial showing that bepirovirsen, an investigational antisense oligonucleotide treatment for hepatitis B, reduced levels of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA after 24 weeks' treatment in people with chronic hepatitis B (CHB).
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B-Clear was a phase 2b, multicenter, randomized, partial blind (sponsor/participant-blinded, investigator-unblinded) parallel-cohort trial that enrolled people with chronic HBV infection receiving stable NA therapy (On-NA) and not currently receiving NA therapy (Not-on-NA). Participants in both populations were randomized to one of four.
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Bepirovirsen is an antisense oligonucleotide that targets all hepatitis B virus (HBV) messenger RNAs and acts to decrease levels of viral proteins. Methods
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The B-Clear phase IIb trial investigated the efficacy and safety of 12 or 24 weeks of treatment with bepirovirsen in people with CHB on stable NA treatment or not-on-NA treatment at study start.
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The B-Clear Phase 2b study is investigating the efficacy and safety of 12- or 24-weeks treatment with bepirovirsen in people living with CHB on stable NA treatment or not on NA treatment at study.
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B-Clear is a phase 2b, multicenter, randomized, partial-blind (sponsor/participant-blinded, investigator-unblinded) study in participants with chronic HBV infection receiving stable nucleos (t)ide analogue (On-NA) or not currently receiving NA therapy (Not-on-NA).
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Qualyst, Inc.'s patented B-CLEAR ® sandwich-cultured hepatocyte technology is the only in vitro method which can evaluate hepatobiliary disposition of a compound, predict in vivo hepatic uptake and biliary clearance, and assess drug transporter-based inhibition.
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B-CLEAR®human sandwich-cultured hepatocytes are used to investigate the hepatobiliary disposition of taurocholic acid in the presence of cholestatic agents.
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Additionally, the letter addressed detect-and-avoid (DAA) equipage on UAS—AOPA recommends the FAA work to certify DAA technologies for UAS that can detect both ADS-B-equipped and non-ADS-B-equipped aircraft. AOPA has been heavily involved in efforts to usher BVLOS operations into the national airspace system for several years and is excited.