The standard dose of PEG-IFN-α-2a (Pegasys®; Roche, Basel, Switzerland) in Japan was used; 90 μg PEG-IFN-α-2a was administered subcutaneously once a week for 48 weeks [5 (link)]. A dose of 0.5 mg entecavir (Baraclude; Bristol-Myers Squibb, New York, USA) was administered daily even after the introduction of add-on PEG-IFN-α-2a treatment. PEG-IFN-α-2a was interrupted based on the following criteria: (1) Hb < 8.5 g/dL; (2) granulocyte count < 500/mm3, or the platelet count < 25,000/mm3; and (3) attending physician deeming necessary due to adverse events. The treatment could be restarted if cytopenia improved. If there was no improvement in hematological parameters or adverse events within four weeks, this therapy was discontinued.
Baraclude
Manufactured by Bristol-Myers Squibb
Sourced in United States
Baraclude is a pharmaceutical product manufactured by Bristol-Myers Squibb. It is a prescription medication used in the treatment of chronic hepatitis B. The core function of Baraclude is to inhibit the replication of the hepatitis B virus, thereby reducing the viral load in patients with chronic hepatitis B.
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Lab products found in correlation
5 protocols using baraclude
1
Pegylated Interferon Alpha-2a Dosing
2
HBV Infection in Humanized Mice
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HUHEP and HIS-HUHEP mice were established in BALB/c Rag2-/-Il2rg-/-SirpaNODuPAtg/tg male and female mice as previously described.18 (link) Mice with >100 μg/mL human Albumin (hAlbumin) and >10% hCD45+ cells in peripheral blood mononuclear cells (PBMC), including human T and B cells, were HBV infected intraperitoneally at 15 (±3) weeks with either 1x107 or 1x109 HBV genome equivalents (GE) purified from concentrated supernatants of the HepG2.2.15 stably producing cell line (HBV genotype D subtype ayw).20 (link), 21 (link) NUC-treated mice had been inoculated with 107 HBV GE for 14 ±1 weeks prior to receiving Entecavir at 0.3 mg/kg/day either injected intraperitoneally or dispensed in the drinking water (Baraclude; Bristol-Myers Squibb, Princeton, NJ). Animals were housed in isolators under pathogen-free conditions with humane care. Experiments were approved by an institutional ethical committee at the Institut Pasteur (Paris, France) and validated by the French Ministry of Education and Research (MENESR #02162.02).
3
Comparative Efficacy and Safety of Entecavir Formulations
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This study was conducted as a multicenter, double-blind, active-controlled, randomized with stratification, parallel group, and comparative trial at 18 sites in South Korea from September 2013 to November 2015. As patients with HBeAg positivity or negativity may differ in their responses to antiviral therapy, a stratified randomization was performed to ensure balance between treatment groups.
All subjects who consented to participate in the present trial provided written informed consent and were subjected to screening tests. Within 4 weeks after screening, subjects who were determined to be eligible for the study were randomized with stratification 1:1 to Baracle (ETV 0.5 mg; Dong-A ST Co., Seoul, Republic of Korea) or Baraclude (ETV 0.5 mg; Bristol-Myers Squibb Korea) treatment groups based on HBeAg status (positive/negative). After stratified randomization, subjects were administered either ETV from Dong-A ST or ETV from BMS via one tablet once daily on an empty stomach (2 hours after taking meal or at least 2 hours before taking meal). Each subject took the investigational products (IP) for 48 weeks, during which the subjects visited the clinical trial institution according to the schedule specified in the study protocol, to receive the planned efficacy and safety assessments.
All subjects who consented to participate in the present trial provided written informed consent and were subjected to screening tests. Within 4 weeks after screening, subjects who were determined to be eligible for the study were randomized with stratification 1:1 to Baracle (ETV 0.5 mg; Dong-A ST Co., Seoul, Republic of Korea) or Baraclude (ETV 0.5 mg; Bristol-Myers Squibb Korea) treatment groups based on HBeAg status (positive/negative). After stratified randomization, subjects were administered either ETV from Dong-A ST or ETV from BMS via one tablet once daily on an empty stomach (2 hours after taking meal or at least 2 hours before taking meal). Each subject took the investigational products (IP) for 48 weeks, during which the subjects visited the clinical trial institution according to the schedule specified in the study protocol, to receive the planned efficacy and safety assessments.
4
Entecavir vs. Pegylated Interferon for Chronic Hepatitis B
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This study was a 48-wk prospective and retrospective treatment trial comparing the efficacy and safety of 0.5 mg entecavir (ETV, Baraclude, Bristol-Myers Squibb) daily for 48 wk compared to switching to pegylated interferon alpha-2a (PegIFNα-2a, F. Hoffmann-La Roche Ltd, Basel, Switzerland). All patents were followed up for 24 wk (Figure 1 ). Patients assigned to PegIFNα-2a received 180 μg/wk for 48 wk, with the first 12 wk overlapping with 0.5 mg daily ETV. Patients assigned to the ETV group continued with ETV monotherapy. A total of 88 patients who had received ETV treatment for at least 48 wk were recruited from the Second Hospital affiliated with Guangzhou Medical University between January 1, 2013, and December 31, 2015. Patients were randomized to receive PegIFNα-2a 180 μg/wk or continue 0.5 mg daily ETV for 48 wk. Eligible patients were HBsAg-positive, had serum HBV-DNA < 500 IU/mL, serum HBeAg < 100 S/CO, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels < 2 × the upper limit of normal (ULN) of 40 IU/L. Patients with decompensated cirrhosis and HCC were excluded; as were patients co-infected with hepatitis A, C, or D; those who had been pre-treated with other antivirals; and patients with a history or evidence of other chronic liver diseases, including autoimmune hepatitis or alcohol liver disease.
5
Sequential Treatment of Chronic Hepatitis B
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The current phase IIIb, randomized, open-label study was conducted in ten centers of South Korea between June 2010 and June 2015. Patients were divided into Peg-IFN monotherapy (Peginterferon Alfa-2α, Pegasys, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 180 μg once weekly for 48 weeks and sequential treatment groups (ETV; Baraclude, Bristol-Myers Squibb, New York, USA) 0.5 mg once daily for 4 weeks followed by a combination of ETV and Pegasys (for 8 weeks), followed by Pegasys alone (for 40 weeks). The randomization was performed using the central computer.
During the treatment period of 48 weeks (+8 weeks), the patients were followed up at 4th, 8th, 12th, 24th, 36th, and 48th week. During each visit, biochemical and hematological assessments were made.
During the treatment period of 48 weeks (+8 weeks), the patients were followed up at 4th, 8th, 12th, 24th, 36th, and 48th week. During each visit, biochemical and hematological assessments were made.
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