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van CCT (UK)

Bilirubin treatment in humans; a study on safety and dose finding.

- candidate number9237
- NTR NumberNTR2807
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2011
- Secondary IDs2009/170 CMO Regio Arnhem - Nijmegen
- Public TitleBilirubin treatment in humans; a study on safety and dose finding.
- Scientific TitleExperimental hyperbilirubinemia; a pharmacokinetic and safety study on the parenteral use of bilirubin.
- hypothesisMultiple observational and animal studies suggest a therapeutic effect of bilirubin in various diseases. To verify this suggestion, intervention studies with experimental hyperbilirubinemia are needed. The current study explores the applicability of the parenteral use of bilirubin, both with regards to safety and pharmacokinetics.
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Bilirubin
- Inclusion criteriaAt least 18 and not older than 65 years of age.
- Exclusion criteria1. Cocumented history of sensitivity or indiosyncrasy to medicinal products or excipients;
2. History of or current abuse of drugs, alcohol or solvents;
3. Use of any medication except for anti-conceptives;
4. Sexually active women in reproductive age group without appropriate anti-conceptive therapy;
5. Any (sign of) active disease;
6. History of liver disease;
7. Laboratory results exceeding twice the upper limit of normal range;
8. Total bilirubin level of 10 micromol/L or higher, suggesting the presence of the Gilbert syndrome.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 14-dec-2010
- planned closingdate1-jul-2011
- Target number of participants6
- InterventionsIncreasing amounts of bilirubin will be administered both intra-arterially (first phase - low total dose) and intravenously (second phase - high total dose). Dose levels will remain far below those levels reported safe in literature.
- Primary outcomeBilirubin concentrations attained after parenteral administration.
- Secondary outcomeSafety parameters including for example body temperature, heart rate and blood pressure.
- TimepointsThe first phase of the study includes the intra-arterial administration of bilirubin. Subjects will be examined subsequently with invariably at least one week in between. Plasma samples will be taken on a regular base to study both local and systemic rises of the bilirubin level. On the condition that no adverse effects are noted, subjects will be re-examined in a second phase in which larger doses of bilirubin will be administered intravenously. Again, subjects will be examined subsequently with invariably at least one week in between. Plasma samples will be taken on a regular base to study systemic rises of the bilirubin level.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Dutch Diabetes Research Foundation
- PublicationsN/A
- Brief summaryParenteral administration of bilirubin has been applied frequently in the past. For now, bilirubin is not commercially available for human research. As several observational studies suggest a beneficial effect of bilirubin with respect to for example cardiovascular disease, we will reintroduce bilirubin for parenteral human use to explore these findings. The current study is performed to assess pharmacokinetic data on intra-arterial and intravenous administration in healthy individuals. Furthermore, side effects will be monitored.
- Main changes (audit trail)
- RECORD14-mrt-2011 - 24-mrt-2011

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