Back to results

Lamprene Multiple Patient Program

Primary Purpose

Non-Tuberculous Mycobacterial (NTM) Infections

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

Lamprene®/Clofazimine

About this trial

This is an expanded access trial for Non-Tuberculous Mycobacterial (NTM) Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients 18 years of age or older
Written informed consent must be obtained before any project specific assessment is performed.
Patients previously diagnosed with NTM infection with local or disseminated infection(i.e. patients with any NTM species at any site of infection)
Patients who failed or are intolerant of prior therapies or who have baseline macrolide resistance or for whom an appropriate regimen cannot otherwise be devised
Male patients (including vasectomized patients) who agree to use a condom during intercourse while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine
Female patients of child-bearing potential with negative pregnancy test before clofazimine treatment initiation and who confirm no intention to become pregnant during the treatment with clofazimine, by using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine

Exclusion Criteria:

History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine
History or current diagnosis of clinically significant ECG abnormalities that pose a safety risk for the patient, such as clinically significant cardiac arrhythmias (e.g.,sustained ventricular tachycardia, second or third degree heart block without a pacemaker)
History or additional risk factors for Torsades de Pointes such as heart failure, clinically relevant hypokalemia, familial long QT syndrome or known family history of Torsades de Pointes
Confirmed demonstration of resting QTcF >500 msec at screening
Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe
Unable to swallow capsules
HIV-infected patients with disseminated NTM infection
Life expectancy less than 6 months
Pregnant or nursing (lactating) females

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04334070

First Posted

April 2, 2020

Last Updated

December 14, 2022

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04334070

Brief Title

Lamprene Multiple Patient Program

Official Title

Novartis Multiple Patient Program for Lamprene® (Clofazimine) for the Treatment of Non-Tuberculous Mycobacterial (NTM) Infections

Study Type

Expanded Access

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM). To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Tuberculous Mycobacterial (NTM) Infections

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lamprene®/Clofazimine

Intervention Description

All participants will receive Lamprene/clofazimine 50 mg capsules. The recommended dose of clofazimine for this program is 100 mg once daily, administered orally, preferably with meals. Duration of treatment will be decided by the treating physician. When considering clofazimine for the treatment of NTM infection, clofazimine is to be administered as part of a multi-drug regimen.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients 18 years of age or older Written informed consent must be obtained before any project specific assessment is performed. Patients previously diagnosed with NTM infection with local or disseminated infection(i.e. patients with any NTM species at any site of infection) Patients who failed or are intolerant of prior therapies or who have baseline macrolide resistance or for whom an appropriate regimen cannot otherwise be devised Male patients (including vasectomized patients) who agree to use a condom during intercourse while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine Female patients of child-bearing potential with negative pregnancy test before clofazimine treatment initiation and who confirm no intention to become pregnant during the treatment with clofazimine, by using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine Exclusion Criteria: History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine History or current diagnosis of clinically significant ECG abnormalities that pose a safety risk for the patient, such as clinically significant cardiac arrhythmias (e.g.,sustained ventricular tachycardia, second or third degree heart block without a pacemaker) History or additional risk factors for Torsades de Pointes such as heart failure, clinically relevant hypokalemia, familial long QT syndrome or known family history of Torsades de Pointes Confirmed demonstration of resting QTcF >500 msec at screening Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe Unable to swallow capsules HIV-infected patients with disseminated NTM infection Life expectancy less than 6 months Pregnant or nursing (lactating) females

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

1-888-669-6682

Novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

12. IPD Sharing Statement

Learn more about this trial

Lamprene Multiple Patient Program

We'll reach out to this number within 24 hrs