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Tracking Information | |||||
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First Received Date † | August 10, 2006 | ||||
Last Updated Date | August 10, 2006 | ||||
Start Date † | March 2003 | ||||
Current Primary Outcome Measures † |
To determine safety and tolerability | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | KRN7000 in Chronic Hepatitis B | ||||
Official Title † | Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis B Infection | ||||
Brief Summary | The purpose of this trial is to determine the safety, tolerability and effectiveness of KRN7000 for chronic hepatitis B infection. |
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Detailed Description | KRN7000 is reported to inhibit HBV replication in HBV transgenic mice. Anti-viral effects of KRN7000 can be expected in HBV, as the compound is able to induce not only IFN-alpha/beta but also IFN-gamma and TNF-alpha. In two clinical trials, KRN7000 was safe in both healthy volunteers and solid cancer patients; particularly, the compound has not been reported to show drug-related serious adverse events. A phase I/II trial is of significance in assessing the safety and efficacy of KRN7000 treatment for CHB patients. The 300 microgram/m2 dose level, comparable to 10 microgram/kg, can be considered as the highest safe dose level for the phase I/II trial for CHB patients with 3 dose levels. Dose incrementation will be performed in a logarithmic manner: 0.1, 1 and 10 microgram/kg. In the phase I trial for solid tumor patients, weekly administration of KRN7000 did not allow sufficient time for NKT cell recovery. As KRN7000 is reported to be an activating ligand for NKT cells, it is logical to assume that a dosing interval that provides time for recovery of NKT cells is optimal. In fact, cytokine production after repeating dosing, when NKT cells were hardly detected in the peripheral blood, was not observed. As it took approximately 4 weeks for NKT cells to recover to pre-dose levels after a single administration, monthly administration is now proposed for this trial. |
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Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Hepatitis B, Chronic | ||||
Intervention † | Drug: KRN7000 | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 28 | ||||
Completion Date | July 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Netherlands | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00363155 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Foundation for Liver Research | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Foundation for Liver Research | ||||
Verification Date | August 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |