Bylvay clinical trials
WebOct 11, 2024 · The double-blind, randomized, placebo-controlled trial was designed to evaluate the safety and efficacy of 120 µg /kg/day Bylvay (odevixibat) for 24 weeks in … WebDec 19, 2024 · Bylvay is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase 3 trial in Alagille syndrome (ALGS), an ongoing Phase 3 study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS.
Bylvay clinical trials
Did you know?
WebMar 29, 2024 · The double-blind, randomized, placebo-controlled trial is designed to evaluate the safety and efficacy of 120 µ g /kg/day Bylvay (odevixibat) for 24 weeks in relieving pruritus in patients with ALGS. Secondary endpoints will measure serum bile acid levels and safety and tolerability.
Web14 CLINICAL STUDIES HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BYLVAY safely and effectively. See full … WebDec 15, 2024 · Clinical Trials: NCT03082937 [ Link] Globe Newswire: Albireo Announces FDA Approval of Bylvay (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC) [ Link] External Links ChemSpider 8329135 RxNav 2563966 ChEMBL CHEMBL4297588 Wikipedia
WebJul 20, 2024 · Albireo is also studying the use of Bylvay in other rare pediatric cholestatic liver diseases with the BOLD Phase 3 clinical trial in patients with biliary atresia and the ASSERT Phase 3 clinical ... WebSep 8, 2024 · Albireo Pharma, Inc. – Bylvay now approved in U.S., EU and UK as first drug treatment for patients with PFIC –. – MHRA decision based on data from the largest Phase 3 PFIC trial to date ...
WebDec 13, 2024 · In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also initiated a Phase 1 clinical trial for A3907...
WebIn Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also initiated a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. red flags of head injuryWebNov 12, 2024 · In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also initiated … red flags of headachesWebJul 23, 2024 · Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. knolly downhill bikeWebMar 8, 2024 · Trial 1 is a randomized, double-blind, placebo-controlled, 24-week study of two dose levels of BYLVAY (40 mcg/kg and 120 mcg/kg) administered once daily. Sixty-two patients were randomized (1:1:1) to receive one of the following: BYLVAY 40 mcg/kg/day (n=23), BYLVAY 120 mcg/kg/day (n=19), or Placebo (n=20). red flags of htnWebSep 15, 2024 · The Company has also initiated a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and ... red flags of credit cardsWebJun 25, 2024 · For general information, Learn About Clinical Studies. Criteria Key Inclusion Criteria: A male or female participant with a clinical diagnosis of PFIC Type 1 or 2 and with a body weight above 5 kg Participant must have clinical genetic confirmation of PFIC-1 or PFIC-2 Participant must have elevated serum bile acid (s-BA) concentration knollwood townhouse apartmentsWebIn a clinical trial, diarrhea was reported in 2 (10%) placebo-treated patients, 9 (39%) Bylvay-treated 40 mcg/kg/day patients and 4 (21%) Bylvay-treated 120 mcg/kg/day patients. … red flags of high blood pressure