Pharmacokinetics and safety of a novel anti-HBs-enriched immunoglobulin in healthy volunteers after subcutaneous and intramuscular administration

Thürmann, Petra A.; Szymański, Jacek; Haffner, Steffen; Tenter, Ute; Grieger, Frank; Sonnenburg, Christel

doi:10.1007/s00228-006-0137-8

Cited by 9 publications

(6 citation statements)

References 9 publications

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“…Results of a preclinical study in rabbits to investigate local tolerability of BT088 showed that the new preparation was well tolerated after a single SC injection. Results of an open, randomized parallel phase I study investigating safety and pharmacokinetic properties of BT088 after SC or IM application in 30 male and female healthy volunteers with a single dose of 30 IU/kg body weight presented pharmacokinetic characteristics which were comparable with data of human HBIg after IV administration (12). Mean anti‐HBs serum concentrations increased to maximum values on day 4 after dosing and the mean elimination half‐live was 3–4 weeks.…”

Section: Introductionmentioning

confidence: 86%

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Yahyazadeh

Beckebaum

Cicinnati

et al. 2011

Transplant International

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Summary Hepatitis B re‐infection prophylaxis is crucial for graft and recipient survival for transplanted patients and is administered routinely after liver transplantation for hepatitis B. Aim of the current study was the investigation of efficacy, safety and feasibility of home‐treatment of a novel human hepatitis B immunoglobulin BT088 (Zutectra®) after weekly subcutaneous application in liver‐transplanted patients. A total of 23 patients (5 female, 18 male, median age 51 years) were enrolled and switched from monthly IV to weekly SC hepatitis B immunoglobulin administration. During a period of 18 weeks (optional 24 weeks) anti‐HBs levels, signs of re‐infection, adverse events and feasibility of self‐administration were studied. After 8 weeks of training patients showing good compliance and stable antibody titres were allowed to start self‐administration at home. All patients maintained a safety level of >100 U/l anti‐HBs. No failure was noted, no re‐infection occurred. A total of 10 treatment‐emergent events were assessed as related to study drug application (injection‐site haematoma, headache, abdominal pain, fatigue and haematuria). High numbers of self‐administration (287 vs. 122 by staff) demonstrated general feasibility of SC administration. Weekly subcutaneous administration of BT088 (Zutectra®– registered trade mark in the EU) is effective, safe and presents an easy‐to‐apply treatment option for combined hepatitis B virus re‐infection prophylaxis in liver transplant patients (Eudra CT Number: 2005‐003737‐40).

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Section: Introductionmentioning

confidence: 86%

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Yahyazadeh

Beckebaum

Cicinnati

et al. 2011

Transplant International

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“…After SC administration, Zutectra is slowly absorbed, achieving a maximum peak after 2-7 days with a half-life of about 3-4 weeks (17). These pharmacokinetic characteristics may vary from patient to patient.…”

Section: Investigational Productmentioning

confidence: 99%

“…SC HBIG injection allows self-administration resulting in a better autonomy of the patients and it is well tolerated. In healthy volunteers, no relevant differences in pharmacokinetic characteristics between IM and SC application of HBIG after a single administration were found (17). Efficacy, safety and feasibility of SC administration in patients after LT have been demonstrated in a recently published phase III study (18).…”

Section: Introductionmentioning

confidence: 95%

Safety and Efficacy of Subcutaneous Hepatitis B Immunoglobulin After Liver Transplantation: An Open Single-Arm Prospective Study

Costanzo¹,

Lanza²,

Picciotto³

et al. 2013

American Journal of Transplantation

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“…A randomized, single-dose trial in healthy volunteers has confirmed that the pharmacokinetics of HBIg are similar using either subcutaneous or intramuscular injection. 16 Clinical studies have shown that the serum anti-HBs concentration remains above 100 IU/L in patients treated with subcutaneous HBIg, [17][18][19] a threshold regarded as the minimum for effective prevention of HBV reinfection in HBV-DNA-negative patients, 20,21 with few adverse events. 22 Previous studies, in which patients were switched from intravenous to subcutaneous HBIg have usually undertaken the conversion at 6 months posttransplantation or later.…”

mentioning

confidence: 99%

Early Introduction of Subcutaneous Hepatitis B Immunoglobulin Following Liver Transplantation for Hepatitis B Virus Infection

et al. 2016

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Pharmacokinetics and safety of a novel anti-HBs-enriched immunoglobulin in healthy volunteers after subcutaneous and intramuscular administration

Cited by 9 publications

References 9 publications

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Safety and Efficacy of Subcutaneous Hepatitis B Immunoglobulin After Liver Transplantation: An Open Single-Arm Prospective Study

Early Introduction of Subcutaneous Hepatitis B Immunoglobulin Following Liver Transplantation for Hepatitis B Virus Infection

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