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Safety and Tolerability Study of rBet v1 SLIT Tablets

20:41 EDT 19th May 2013 | BioPortfolio

Summary

The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Birch Pollen-Related Rhinoconjunctivitis

Intervention

rBet v 1, Placebo

Location

National University Hospital - Allergy Unit 4222
Copenhagen
Denmark
2100

Status

Completed

Source

Stallergenes

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Pollen Tube

A growth from a pollen grain down into the flower style which allows two sperm to pass, one to the ovum within the ovule, and the other to the central cell of the ovule to produce endosperm of SEEDS.

Therapeutic Misconception

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Alnus

A plant genus of the family BETULACEAE that is distinguished from birch (BETULA) by its usually stalked winter buds and by cones that remain on the branches after the small, winged nutlets are released.

Abscisic Acid

Abscission-accelerating plant growth substance isolated from young cotton fruit, leaves of sycamore, birch, and other plants, and from potatoes, lemons, avocados, and other fruits.

Placebo Effect

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Clinical Trials [ 156 Associated Clinical Trials listed on BioPortfolio]

Study of rBet v1 Tablets

The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.

Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV

Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis

Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

Analysis of Immunological Reactions to Foods in Birch Pollen-Allergic Patients

A high number of birch pollen-allergic individuals develop hypersensitivity reactions to certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch polle...

SUBLIVAC® Birch PROBE Study

Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic...

PubMed Articles [ 4521 Associated PubMed Articles listed on BioPortfolio]

Hypoallergenic derivatives of the major birch pollen allergen Bet v 1 obtained by rational sequence reassembly.

BACKGROUND: At least 100 million patients suffer from birch pollen allergy. OBJECTIVE: Rational design of recombinant derivatives of the major birch pollen allergen, Bet v 1, characterized by reduced...

Anaphylactic reaction after soya intake in a patient with birch pollen allergy.

Patients with birch pollen allergy may suffer from severe anaphylactic reactions after ingestion of foodstuffs containing soya. The reason for this is similarities in protein structure between a major...

Proteomic analysis of the major birch allergen Bet v 1 predicts allergenicity for 15 birch species.

Pollen of the European and Asian white birch (Betula pendula and B. platyphylla) causes hay fever in humans. The allergenic potency of other birch species is largely unknown. To identify birch trees w...

Immunotherapy with depigmented-polymerized mixed tree pollen extract: a clinical trial and responder analysis.

To cite this article: Pfaar O, Robinson DS, Sager A, Emuzyte R. Immunotherapy with depigmented-polymerized mixed tree pollen extract: a clinical trial and responder analysis. Allergy 2010; DOI: 10.111...

Continuous apple consumption induces oral tolerance in birch-pollen-associated apple allergy.

To cite this article: Kopac P, Rudin M, Gentinetta T, Gerber R, Pichler C, Hausmann O, Schnyder B, Pichler WJ. Continuous apple consumption induces oral tolerance in birch-pollen-associated apple alle...

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