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Tracking Information | |||||
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First Received Date ICMJE | August 25, 2006 | ||||
Last Updated Date | January 7, 2008 | ||||
Start Date ICMJE | July 2006 | ||||
Current Primary Outcome Measures ICMJE |
AUC | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00369187 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Tmax, Cmax, half-lives, injection site reactions, safety and tolerability, NAbs | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase | ||||
Official Title ICMJE | |||||
Brief Summary | This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose of rHuPH20 will increase the bioavailability of large molecule drug administration. |
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Detailed Description | Sequential enrollment into four rHuPH20 dose cohorts. |
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Study Phase | Phase IV | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study | ||||
Condition ICMJE | Rheumatoid Arthritis | ||||
Intervention ICMJE | Drug: large protein molecule | ||||
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 ICMJE | Completed | ||||
Enrollment ICMJE | 15 | ||||
Completion Date | October 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00369187 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | HZ2-06-02 | ||||
Study Sponsor ICMJE | Halozyme Therapeutics | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Halozyme Therapeutics | ||||
Verification Date | January 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |