The Experts below are selected from a list of 90 Experts worldwide ranked by ideXlab platform

Byung Chul Yoo - One of the best experts on this subject based on the ideXlab platform.

  • A phase II dose‐escalating trial of clevudine in patients with chronic Hepatitis B
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Herve Mommeja-marin, M. Robert Blum, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)

  • a phase ii dose escalating trial of clevudine in patients with chronic Hepatitis b
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Herve Mommejamarin, Robert M Blum, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)

Patrick Marcellin - One of the best experts on this subject based on the ideXlab platform.

  • A phase II dose‐escalating trial of clevudine in patients with chronic Hepatitis B
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Herve Mommeja-marin, M. Robert Blum, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)

  • a phase ii dose escalating trial of clevudine in patients with chronic Hepatitis b
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Herve Mommejamarin, Robert M Blum, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)

Gijsbert C De Gast - One of the best experts on this subject based on the ideXlab platform.

  • Passive-active immunization in infants of Hepatitis Be Antigen-positive mothers. Comparison of the efficacy of early and delayed active immunization.
    JAMA Pediatrics, 1993
    Co-Authors: P M Grosheide, Riwka Del Canho, Rudolf A Heijtink, Ad S M Nuijten, John Zwijnenberg, John R J Banffer, Yuriy W Wladimiroff, Meindert J Botman, Adriaan J Mazel, Gijsbert C De Gast
    Abstract:

    • Objective. —To assess the efficacy of late active immunization against Hepatitis B concomitant with diphtheria, pertussis, tetanus, and polio vaccine in high-risk infants receiving Hepatitis B immune globulin at birth. Design. —Randomized study of infants born to mothers positive for Hepatitis B surface Antigen (HBsAg) and Hepatitis Be Antigen (HBeAg). Setting. —Three large city hospitals and one rural area providing prenatal care and obstetric services. Subjects. —Eighty neonates of HBsAg- and HBeAg-positive carrier mothers received 0.5 mL/kg of body weight Hepatitis B immune globulin within 2 hours of birth and Hepatitis B vaccine (10 μg) at 0,1, 2, and 11 months of age (group A) or at 3, 4, 5, and 11 months of age concomitant with diphtheria, pertussis, tetanus, and polio immunization (group B). A second dose of Hepatitis B immune globulin was given to infants on schedule B at 3 months. Main Outcome Measures. —Blood samples were collected at 0,3,6,11, and 12 months of age and tested for antibodies against Hepatitis B core Antigen and HBsAg. Follow-up visits were scheduled annually up to 5 years of age. Results. —Eight infants were excluded from analysis. During the study period, six children Became HBsAg carriers, three in each group, which corresponds to a 5-year incidence of infection of 9% and 8% for groups A (three of 35) and B (three of 37), respectively. Subclinical infections (persistent anti-HBc positivity Beyond month 12 or appearance of anti-HBc) were encountered in another eight infants (four in each group). Conclusion. —Late active immunization starting at 3 months of age appears to provide similar protective efficacy as active immunization starting at birth when combined with Hepatitis B immune globulin at 0 and 3 months of age. ( AJDC . 1993;147:1316-1320)

Brian Conway - One of the best experts on this subject based on the ideXlab platform.

  • A phase II dose‐escalating trial of clevudine in patients with chronic Hepatitis B
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Herve Mommeja-marin, M. Robert Blum, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)

  • a phase ii dose escalating trial of clevudine in patients with chronic Hepatitis b
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Herve Mommejamarin, Robert M Blum, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)

Christian Trepo - One of the best experts on this subject based on the ideXlab platform.

  • A phase II dose‐escalating trial of clevudine in patients with chronic Hepatitis B
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Herve Mommeja-marin, M. Robert Blum, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)

  • a phase ii dose escalating trial of clevudine in patients with chronic Hepatitis b
    Hepatology, 2004
    Co-Authors: Patrick Marcellin, George K K Lau, Christian Trepo, Stephen L. Sacks, Daniel Sereni, Jean-pierre Bronowicki, Brian Conway, Herve Mommejamarin, Robert M Blum, Byung Chul Yoo
    Abstract:

    Current therapies available for the treatment of chronic Hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-Hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 × 106 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or Hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were Hepatitis Be Antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log10 copies/mL. After 28 days, the median HBV DNA log10 change from baseline was −2.5, −2.7, −3.0, and −2.6 log10. Six months after dosing, median changes from baseline were −1.2, −1.4, −2.7 and −1.7 log10 in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study. (HEPATOLOGY 2004;40:140–148.)