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Pharmacokinetics of New HepBQuin

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ClinicalTrials.gov Identifier: NCT03899142
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sanquin Plasma Products BV

Brief Summary:
Sanquin Plasma Products BV developed a new manufacturing process for the Quin plasma products in order to improve viral safety and to remove procoagulant activity. Since the new manufacturing process will be the same for all Quin products, a clinical study with one of the Quin products is sufficient for marketing authorisation of all new Quin products. HepBQuin will serve as model for all other Quin products. Pharmacokinetic (PK) data are considered as a surrogate indicator of efficacy.

Condition or disease Intervention/treatment Phase
Healthy Biological: a human hepatitis B immunoglobulin solution for injection for intramuscular administration Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics of HepBQuin Manufactured According to a New Production Process
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : July 4, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis B

Arm Intervention/treatment
Experimental: human hepatitis B immunoglobulin
once, i.m.
Biological: a human hepatitis B immunoglobulin solution for injection for intramuscular administration
intramuscular administration




Primary Outcome Measures :
  1. half-life of anti-HBs antibodies [ Time Frame: 84 days ]
    Pharmacokinetics


Secondary Outcome Measures :
  1. number of adverse events [ Time Frame: 84 days ]
    Safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers, male and female, aged 18 to 65 inclusive.
  • Negative serology test for HBsAg, anti-HBs, and anti-HBc at screening.
  • Body-mass index (BMI) of 18.5 to 32.0 kg/m2 (inclusive).
  • Female volunteers must have a pregnancy test at screening.
  • Willing to participate by signing the written signed informed consent form.

Exclusion Criteria:

  • Vaccinated against Hepatitis B
  • Having a Hepatitis B infection or suffered from a Hepatitis B infection in the past.
  • Known with allergic reactions against human plasma, plasma products or blood products.
  • A history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
  • Known with or having a history of arterial or venous thromboembolic events.
  • Pre-existing risk factors for thrombotic events.
  • Any clinically significant history of or current clinically significant other disease or disorder.
  • Any clinically significant abnormality following the investigator's review of physical examination, and clinical laboratory tests obtained at screening.
  • An abnormal pulse rate and/or blood pressure measurements at the screening visit.
  • Pregnant or breast-feeding at screening or at Day 0
  • Women of childbearing potential not using a highly effective method of birth.
  • Any use of drugs or abuse within 3 months prior to screening and during study.
  • Alcohol abuse within 3 months prior to screening and during study
  • Participated in another interventional clinical trial a month before the start of the study, or having received an experimental drug during the previous 30 days.
  • Having IgA deficiency with anti-IgA antibodies.
  • Blood or plasma donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899142


Contacts
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Contact: Ilona Kleine Budde, PhD +31205123537 i.kleinebudde@sanquin.nl

Locations
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Germany
CRS Clinical Research Services Mannheim GmbH Recruiting
Mannheim, Germany
Contact: Güven Sayan    +4962115045 - 0    Gueven.Sayan@crs-group.de   
Principal Investigator: Uwe Theiss, Dr. med.         
Sponsors and Collaborators
Sanquin Plasma Products BV

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Responsible Party: Sanquin Plasma Products BV
ClinicalTrials.gov Identifier: NCT03899142     History of Changes
Other Study ID Numbers: MD2017.01
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs