Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

NCT00289991 | Completed Phase 3 Results DMC

• 1 other identifier: A1501073
• Study Type: interventional
• Target: 489
• Locations: 12 countries
• Sites: 49

Brief Summary

Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.

Conditions

Antifungal Prophylaxis of Invasive Fungal Infections

Outcome Measures

Primary Outcomes (1)

• Success at Day 180: Percent of Responders (Randomization Strata)

  Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).

  Day 180 (Visit 9)

Secondary Outcomes (8)

• Success at Day 100: Percent of Responders (Randomization Strata)

  Day 100 (Visit 7)

• Time to Breakthrough Invasive Fungal Infection (IFI)

  Day 1 up to Day 180 (Visit 9)

• Percent of Subjects With Occurrence of Breakthrough IFI

  Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)

• Survival: Percent of Subjects Who Died at or Before Day 180

  Day 1 up to Day 180 (Visit 9)

• Time to Discontinuation of Study Treatment

  Day 1 up to Day 180 (Visit 9)

Study Arms (2)

Itraconazole

ACTIVE COMPARATOR

Drug: Itraconazole

Voriconazole

EXPERIMENTAL

Drug: Vfend - voriconazole

Interventions

Itraconazole DRUG

Prophylaxis

Itraconazole

Vfend - voriconazole DRUG

Prophylaxis

Also known as: Vfend

Voriconazole

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML
• Male and Female over 12 years or greater

You may not qualify if:

• Possible, probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
• Previous history of zygomycosis
• Anticipated survival less than one month

Sponsors & Collaborators

• Pfizer: lead

Study Sites (49)

Pfizer Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3E 0V9, Canada

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Pfizer Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

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Pfizer Investigational Site

Montreal, Quebec, H1T 2M4, Canada

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Pfizer Investigational Site

Bmo, 625 00, Czechia

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Pfizer Investigational Site

Prague, 128 20, Czechia

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Pfizer Investigational Site

Cairo, Egypt

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Pfizer Investigational Site

Marseille, Cedex 09, 13273, France

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Pfizer Investigational Site

Caen, 14033, France

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Pfizer Investigational Site

Créteil, 94010, France

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Pfizer Investigational Site

Paris, 75475, France

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Pfizer Investigational Site

Pessac, 33600, France

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Pfizer Investigational Site

Rouen, 76038, France

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Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54511, France

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Pfizer Investigational Site

Villejuif, 94805, France

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Pfizer Investigational Site

Exohi Asvestohoriou, Thessaloniki, 57010, Greece

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Pfizer Investigational Site

Athens, 11527, Greece

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Pfizer Investigational Site

Amman, Jordan

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Pfizer Investigational Site

Lisbon, 1099-023, Portugal

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Pfizer Investigational Site

Porto, 4200-072, Portugal

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Pfizer Investigational Site

Moscow, 117997, Russia

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Pfizer Investigational Site

Saint Petersburg, 197089, Russia

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Pfizer Investigational Site

Badalona, Barcelona, 08916, Spain

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Pfizer Investigational Site

Barcelona, Barcelona, 08025, Spain

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Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

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Pfizer Investigational Site

Madrid, Madrid, 28006, Spain

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Pfizer Investigational Site

Madrid, Madrid, 28034, Spain

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Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

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Pfizer Investigational Site

Salamanca, Salamanca, 37007, Spain

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Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

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Pfizer Investigational Site

Valencia, Valencia, 46009, Spain

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Pfizer Investigational Site

Valencia, Valencia, 46010, Spain

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Pfizer Investigational Site

Ch-4031 Basel, Switzerland

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Pfizer Investigational Site

Geneva, CH-1211, Switzerland

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Pfizer Investigational Site

Ankara, 06590, Turkey (Türkiye)

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Pfizer Investigational Site

Kayseri, 38039, Turkey (Türkiye)

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Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

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Pfizer Investigational Site

Bristol, BS2 8BL, United Kingdom

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Pfizer Investigational Site

Cambridge, CB2 2QQ, United Kingdom

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Pfizer Investigational Site

Cardiff, CF14 4XW, United Kingdom

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Pfizer Investigational Site

Glasgow, G12 0YN, United Kingdom

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Pfizer Investigational Site

Glasgow, G4 0SF, United Kingdom

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Pfizer Investigational Site

Leeds, LS9-7TF, United Kingdom

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Pfizer Investigational Site

Leicester, LW1 5WW, United Kingdom

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Pfizer Investigational Site

London, Nw3 2qg, United Kingdom

Location

Pfizer Investigational Site

London, SE1 9RT, United Kingdom

Location

Pfizer Investigational Site

London, SE5 9RS, United Kingdom

Location

Pfizer Investigational Site

Manchester, M20 4BX, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Itraconazole; Voriconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Limitations and Caveats

Data was excluded from 1 site due to Good Clinical Practices deviations.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: March 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 20, 2015
• Results First Posted: March 10, 2010

Record last verified: 2015-10

Locations

GB (12); FR (8); PT (2); CH (2); GR (2); JO (1); EG (1); CA (5); RU (2); ES (10); TU (2); CZ (2)