Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-03-12 @ 7:59 PM
Study NCT ID:
NCT01918956
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
2013-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PURETHAL Birch RUSH Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-10', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients successfully reaching the maintenance dose', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Early and late local and systemic reactions', 'timeFrame': '30 minutes after IMP injection and 24 hours after injection'}, {'measure': 'Immunological parameters (IgE, IgG)', 'timeFrame': '10 weeks rush regime, 13 weeks conventional regime'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'birch pollen', 'seasonal allergy', 'up-dosing'], 'conditions': ['Allergic Rhinitis', 'Allergic Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).\n\nThe primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes.\n\nA similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent.\n* Age ≥12 years.\n* Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma\n* FEV1\\>70% for patients with a history of mild to moderate asthma, FEV1\\>70% or PEF\\>80% for patients without a history of asthma\n* A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen.\n* Positive serum specific anti-birch IgE-test (\\>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization.\n\nExclusion Criteria:\n\n* Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years\n* Any specific immunotherapy (SCIT or SLIT) during the study period\n* Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs\n* Active malignancies or any malignant disease within the past 5 years\n* Severe uncontrolled diseases that could increase the risk for patients participating in the study\n* Acute/active inflammation or infection of the target organs at the start of the study\n* Secondary changes of the target organ\n* Diseases with a contraindication for the use of adrenaline\n* Use of systemic steroids within 4 weeks before start of the study and during the study\n* Treatment with systemic and local β-blockers\n* Vaccination within one week before start of therapy or during the initiation phase\n* Anti-IgE therapy within the 6 months prior to inclusion and during the study\n* Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study\n* Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age\n* Alcohol, drug or medication abuse within the past year\n* Any clinically significant abnormal laboratory parameter at screening\n* Lack or expected lack of cooperation or compliance\n* Severe psychiatric, psychological, or neurological disorders\n* Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator'}, 'identificationModule': {'nctId': 'NCT01918956', 'briefTitle': 'PURETHAL Birch RUSH Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'HAL Allergy'}, 'officialTitle': 'A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Birch Given With a Rush Up-dosing Regimen to Patients With Allergic Rhinitis/Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'PB/0040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional regimen of PURETHAL Birch', 'description': 'Initial treatment:\n\n6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3, 4, 5, 6).\n\nMaintenance treatment:\n\n0.5 ml PURETHAL Birch, 20.000 AUM/ml, in intervals according to registered scheme (week 8, 10, 12).', 'interventionNames': ['Biological: PURETHAL Birch, 20.000 AUM/ml']}, {'type': 'EXPERIMENTAL', 'label': 'rush regimen of PURETHAL Birch', 'description': 'Initial treatment:\n\n3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3)\n\nMaintenance treatment:\n\n0.5 ml PURETHAL Birch, 20.000 AUM/ml, in 2-weekly intervals (week 5, 7, 9).', 'interventionNames': ['Biological: PURETHAL Birch, 20.000 AUM/ml']}], 'interventions': [{'name': 'PURETHAL Birch, 20.000 AUM/ml', 'type': 'BIOLOGICAL', 'description': 'comparison of different up-dosing regimes', 'armGroupLabels': ['conventional regimen of PURETHAL Birch', 'rush regimen of PURETHAL Birch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15-183', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '43-300', 'city': 'Bielsko-Biala', 'country': 'Poland', 'facility': 'NZOZ Alergia', 'geoPoint': {'lat': 49.82245, 'lon': 19.04686}}, {'zip': '80-405', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'NZOZ ClinicaVitae', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-954', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Medica Pro Familia Sp.zo.o S.K.A', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '33-100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '33-100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'Specjalistyczne Centrum Medyczne CenterMed', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '53-428', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'NZOZ CUM PROXIMUM Sp. z o.o.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '90-553', 'city': 'Łódz', 'country': 'Poland', 'facility': 'NZOZ Centrum Alergologii'}], 'overallOfficials': [{'name': 'Piotr Buczyłko, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NZOZ Centrum Alergologii'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HAL Allergy', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ergomed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}