Efficacy and Safety From a Recombinant Folding Variant of Bet v 1
This study has been completed.
Sponsor:
Allergopharma GmbH & Co. KG
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00554983
First received: November 6, 2007
Last updated: March 8, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | November 6, 2007 | ||||
| Last Updated Date | March 8, 2013 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Symptom-Medication-Score [ Time Frame: during pollen season ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Symptom-Medication-Score [ Time Frame: during pollen season ] | ||||
| Change History | Complete list of historical versions of study NCT00554983 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 | ||||
| Official Title ICMJE | A Multicentre Randomised Placebo-controlled Double-blind Pivotal Clinical Trial for the Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v 1-FV | ||||
| Brief Summary | Efficacy and Safety from a recombinant folding variant of Bet v 1 |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Allergy | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 255 | ||||
| Completion Date | May 2012 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00554983 | ||||
| Other Study ID Numbers ICMJE | AL0702rB, 2007-001029-84 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Allergopharma GmbH & Co. KG | ||||
| Study Sponsor ICMJE | Allergopharma GmbH & Co. KG | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Allergopharma GmbH & Co. KG | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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