Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2006-006980-22-HU
EUCTR2006-006980-22-HUActive, not recruitingNot Applicable

MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA

Transave, Inc.0 sites60 target enrollmentStarted: April 3, 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
60
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •CF study subjects with mild to moderate obstructive lung disease (FEV1% predicted = 40%) will be eligible for enrollment. Study subjects must be 6 years old or older. To be eligible, study subjects must also have history of sputum containing Pseudomonas aeruginosa.
  • •1) Written informed consent prior to the performance of any study related
  • •2) Male or female study subjects = 6 years of age or older
  • •3) Confirmed diagnosis of CF defined as a positive sweat chloride > 60 mEq/liter
  • •(by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations
  • •consistent with CF accompanied by one or more clinical features of the CF
  • •4) History of chronic infection with P. aeruginosa (defined as 3 documented positive
  • •cultures in the prior 2 years of which at least one was obtained in the 3 months
  • •prior to randomization. The cultures could be obtained from the following
  • •respiratory secretions:
  • •sputum, throat swabs, nasopharyngeal swabs or broncho-alveolar lavage fluid
  • •5) Study subjects must produce a screening specimen (expectorated or induced
  • •sputum, throat swabs, nasopharyngeal swabs or broncho-alveolar lavage fluid)
  • •that is positive for growth of P. aeruginosa
  • •6) FEV1 = 40% of predicted at Screening
  • •7) SaO2 = 90% at Screening while breathing room air
  • •8) Ability to comply with study medication use, study visits, and study procedures as
  • •judged by the investigator
  • •9) Ability to produce 0.5 grams sputum or be willing to undergo an induction to
  • •produce sputum for clinical evaluation
  • •10)Clinically stable with no evidence of acute upper or lower respiratory tract
  • •infection or history of pulmonary exacerbation within the 4 weeks prior to
  • •randomization
  • •Main criteria for inclusion of patients participating in the 6 months extension period:
  • •1) Written informed consent obtained from the patient or designated legal guardian prior to the performance of any study related procedures in the extension period
  • •2) Patient meets all of the above listed inclusion criteria (1-10) of the main protocol
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1) Administration of any investigational drug within 8 weeks prior to Screening
  • •2) Emergency room visit or hospitalization for CF or respiratory-related illness within
  • •the 4 weeks prior to screening
  • •3) History of alcohol, medication, or illicit drug abuse within the 1 year prior to
  • •4) History of lung transplantation
  • •5) Female of childbearing potential who is lactating or is not practicing an acceptable
  • •method of birth control (e.g., abstinence, hormonal or barrier methods, partner
  • •sterilization, or IUD)
  • •6) Positive pregnancy test. All women of child bearing potential will be tested
  • •7) Use of any anti-pseudomonal antibiotics (IV antibiotics, all inhalation antibiotics,
  • •oral fluoroquinolones) within the 28 days prior to screening.
  • •8) Initiation of chronic therapy (i.e. TOBI®, high-dose ibuprofen, rhDNase, macrolide
  • •antibiotics) within the 28 days prior to screening
  • •9) History of sputum or throat swab culture yielding Burkholderia cepacia within 2
  • •years of Screening
  • •10)History of mycobacterial infection
  • •11)History of biliary cirrhosis, portal hypertension, or splenomegaly (refer to study
  • •12)GGT, AST, or ALT = 3 times the upper limit of normal at Screening visit
  • •13)ANC = 1000 performed at Screening visit
  • •14)Serum creatinine > 1.5 times normal performed at Screening visit
  • •15)History of daily, continuous oxygen supplementation or requirement for more
  • •than 2 L/min at night
  • •16)Change in chest x-ray at screening (or within the 3 months prior to screening)
  • •with new onset infiltrates or that which compromise the safety of the study
  • •patient or the quality of the study data
  • •Main criteria for exclusion of patients participating in the 6 months extension period:
  • •1)Patient meets all criteria for exclusion as listed above in the main protocol
  • •2)Patient which met any criteria for study drug discontinuation in the main protocol (see section 5.3 Criteria for Study Drug Discontinuation)

Investigators

Similar Trials

Active, not recruiting
Phase 1
MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSACystic fibrosis
EUCTR2006-006980-22-SKTransave, Inc.60
Active, not recruiting
Phase 1
MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSACystic fibrosis
EUCTR2006-006980-22-PLTransave, Inc.60
Active, not recruiting
Not Applicable
MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosisCystic fibrosis
EUCTR2006-006980-22-BETransave, Inc.60
Completed
Not Applicable
STUDY ON THE SAFETY AND TOLERANCE OF MULTIPLE DOSE OF DESLORATADINE IN PEDIATRIC SUBJECTS ATOPICOS AND PEDIATRIC SUBJECTS WITH CIU, FROM> 2 TO <12 YEARS OF AGE, WHICH ARE SLOW METABOLIZERS OF DYSORATADINE
PER-078-02SCHERING PLOUGH RESEARCH INSTITUTE,
Active, not recruiting
Not Applicable
Clinical trials assessing efficacy, safety and tolerability of different doses of oral cebranopadol in patients with moderate to severe chronic pain due to diabetic peripheral neuropathy
EUCTR2013-000473-68-DEGrünenthal GmbH699