NCT00841516

Brief Summary

This trial is performed for the immunological and histological evaluation of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen, rBet v1-FV

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

3.3 years

First QC Date

February 10, 2009

Last Update Submit

November 7, 2013

Conditions

Allergic Rhinoconjunctivitis

Keywords

Specific immunotherapySITSCITrecombinantType 1 - Allergy

Outcome Measures

Primary Outcomes (1)

  • Changes in populations of inflammatory cells and subpopulations of immunologically active cells.

    All these cells were evaluated in nasal biopsies obtained before the start of treatment (outside the birch pollen season) and during immunotherapy (after one year of treatment with rBet v1-FV) around the peak of the pollen season.

    Cells were obtained before and after one year of treatment with rBet v1-FV.

Secondary Outcomes (1)

  • Immunologic changes

    4 time points.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo was given the same way as a subcutaneous (just under the skin) injection.

Other: Placebo

80 µg rBet v1-FV Immunotherapy

EXPERIMENTAL

All randomized patients were treated with either placebo or 80 µg rBet v1-FV (maintenance dose) for 2 years.

Biological: rBet v1-FV

Interventions

PlaceboOTHER

Placebo was given the same way as a subcutaneous (just under the skin) injection.

Also known as: Comparator
Placebo
rBet v1-FVBIOLOGICAL

Placebo was given the same way as a subcutaneous (just under the skin) injection.

Also known as: Specific Immunotherapy
80 µg rBet v1-FV Immunotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

You may not qualify if:

  • Serious chronic diseases
  • Other perennial allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. med. Sabina Rak

Gothenburg, 41345, Sweden

Location

Related Links

Study Officials

  • Sabina Rak, Prof.Dr.med.

    Prof. Dr. med. Rak

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

December 1, 2007

Primary Completion

April 1, 2011

Study Completion

May 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

SE(1)