An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

NCT01454531 | Completed Phase 2 Results

• 1 other identifier: AV-G-01
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to assess the tolerability of AVANZ.

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Frequency of Subjects With Adverse Drug Reactions

  Frequency of patients with adverse reactions, local or systemic

  6 weeks

Secondary Outcomes (5)

• Frequency of Subjects With Systemic Reactions

  6 weeks

• Frequency of Subjects With Local Adverse Reaction

  6 weeks

• Change in Phleum Pratense Specific IgE-blocking Factor

  baseline (visit 1) and at 6 weeks (visit 6)

• Change in Phleum Pratense Specific IgG4

  baseline (visit 1) and at 6 weeks (visit 6)

• Change in Immediate Cutaneous Response to Phleum Pratense

  baseline (visit 1) and at 6 weeks (visit 6)

Study Arms (1)

AVANZ Phleum pratense

EXPERIMENTAL

AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

Drug: AVANZ Phleum pratense

Interventions

AVANZ Phleum pratense DRUG

AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

AVANZ Phleum pratense

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of grass pollen rhinoconjunctivitis
• Positive SPT to Phleum pratense
• Positive specific IgE against Phleum pratense

You may not qualify if:

• Uncontrolled severe asthma

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (20)

Hospital de Basurto

Bilbao, Bilbao, 48013, Spain

Location

Fundación Jiménez Diaz

Madrid, Madrid, 28025, Spain

Location

Hospital Infanta Elena

Madrid, Madrid, 28342, Spain

Location

Hospital Universitari Politecnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Nuestra Señora de Sonsoles

Ávila, 05071, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, 06007, Spain

Location

Complejo Hospitalario de Burgos

Burgos, 09001, Spain

Location

Hospital Nuestra Señora de La Montaña

Cáceres, 10004, Spain

Location

H. Campo Arañuelo

Cáceres, 10300, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Univesitario Fundación Hospital de Alcorcón

Madrid, 28922, Spain

Location

Hospital Carlos Haya

Málaga, 29009, Spain

Location

Hospital Rio Carrion

Palencia, 34005, Spain

Location

Hospital Santa Bárbara

Puertollano, 13500, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Univeritario Marques de Valdeilla

Santander, 39008, Spain

Location

Hospital Santiago Apostol

Vitoria-Gasteiz, 01004, Spain

Location

Hospital Virgen de La Concha

Zamora, 49022, Spain

Location

Results Point of Contact

• Title: ALICIA MARIN
• Organization: ALK-ABELLÓ

amaes@alk.net

+34 913276127

Study Officials

• JOAQUIN SASTRE, MD, PhD

  FUNDACIÓN JIMÉNEZ DIAZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 19, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 6, 2015
• Results First Posted: March 6, 2015

Record last verified: 2015-02

Locations

ES (20)