Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients
This study has been terminated.
(study completed)
Sponsor:
University of Pittsburgh
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00235651
First received: October 6, 2005
Last updated: December 16, 2008
Last verified: December 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to quantify the dose of aerosol medication deposited in the lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized Abelcet® (lipid complexed amphotericin-B). This study is being performed to determine the range of deposited doses and patterns of distribution that could be expected in this population so that the ultimate efficacy of this preparation can be evaluated. A radioisotope technique will be utilized to track the medication dose. The study will include 12 subjects who will perform one testing session lasting approximately 3 hours. An Investigational New Drug Application (IND) detailing this protocol has been submitted by the principal investigator (PI) and approved by the Food and Drug Administration [FDA] (72,521).
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Transplantation Lung Diseases |
Drug: Amphotericin B |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic and Deposition Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet®) in Lung Transplant Recipients (Radiotagging Protocol) |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- to determine the dose of medication deposited in the lungs
Secondary Outcome Measures:
- to determine the regional distribution of the drug in the lungs
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2005 |
| Study Completion Date: | April 2006 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Single or double lung transplant recipients
- Age > 18
- Willing to be available at the testing center
- Able to understand and complete informed consent
Exclusion Criteria:
- Pregnant women, or women capable of bearing children who will not perform urine pregnancy test.
- Nursing mothers.
- Hypersensitivity to amphotericin B (Abelcet®) or technetium [Tc-99m] based radiopharmaceuticals.
- Subjects with a past history of bronchospasm associated with aerosol drug use
- Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications
- Subjects with an FEV1 < 30% predicted or forced vital capacity (FVC) % predicted < 30%
- Subjects requiring supplemental oxygen
- Receipt of inhalational or IV amphotericin B within last 30 days
- Subjects with known fungal infection, as per Mycoses Study Group (MSG) criteria, on therapy with antifungal drugs or diagnosed on the day of bronchoscopy
- Serum creatinine > 1.9 mg/dl on the day of clinic visit
- Liver enzymes ALT/AST/alk phos greater than two times the normal limit
- Concurrent intravenous aminoglycoside use
- Subjects with fever > 38.2°C
- Subjects on mechanical ventilation.
- Have participated in any studies involving radiopharmaceuticals within 14 days.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235651
Locations
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
University of Pittsburgh
Enzon Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Shahid Husain, MD | University of Pittsburgh |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00235651 History of Changes |
| Other Study ID Numbers: | IRB# 0509013 |
| Study First Received: | October 6, 2005 |
| Last Updated: | December 16, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
Lung transplant recipient |
Additional relevant MeSH terms:
|
Lung Diseases Respiratory Tract Diseases Amphotericin B Liposomal amphotericin B Amebicides Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013