NL-OMON43501
Completed
Phase 3
An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) That are Refractory to Treatment - INS-312
lnsmed lncorporated0 sites1 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lung infection
- Sponsor
- lnsmed lncorporated
- Enrollment
- 1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects are eligible to participate in the study if they meet all the following inclusion criteria:
- •1\. have successfully completed the Month 6 and EOT visits in INS\-212
- •2\. have not achieved the INS\-212 protocol definition of culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 in INS\-212
- •have experienced a relapse or recurrence (agar positive or more than 2 consecutive broth positive results after culture conversion has occurred) by Month 6 in INS\-212
- •3\. have demonstrated compliance with treatment regimen in INS\-212, including LAI, if applicable
- •4\. willing to adhere to multi\-drug treatment regimen during the course of the study
- •5\. female of child bearing potential agrees to practice an acceptable method of birth control (e.g., true abstinence \[refraining from heterosexual intercourse during the study], hormonal or barrier
- •methods, partner sterilization, or intrauterine device \[IUD]) while participating in the trial. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post\-ovulation methods), declaration of abstinence for the duration of the study, and withdrawal are not acceptable methods of contraception.
- •6\. the subject will provide written informed consent
- •7\. willing to have serum and sputum specimens stored
Exclusion Criteria
- •Subjects are not eligible to participate in the study if they meet any of the following criteria:
- •1\. achieved culture conversion without relapse or recurrence in the INS212study by Month 6
- •2\. early discontinuation (prior to Month 6 study visit) from INS\-212
- •3\. met any of the exclusion criteria of the INS\-212 study, with the exception of the following:
- •a. unable to perform the 6MWT
- •b. prior exposure to LAI (including clinical study)
- •c. in the opinion of the Investigator, patients who are not expected to survive the duration of the study
- •d. active allergic bronchopulmonary mycosis or any other condition requiring chronic systemic corticosteroids at a dose greater than the equivalent of 10 mg/day of prednisone within 3 months before Baseline (Day 1\)
- •e. initiation of chronic therapy (e.g., high dose ibuprofen, inhaled anti\-inflammatory agents including steroids, low dose maintenance steroids, rhDNase) at Baseline (Day 1\)
- •4\. positive pregnancy test or lactation. All women of child bearing potential will be tested. Women not of child bearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile.
Outcomes
Primary Outcomes
Not specified
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