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Protocol Details

Multiple Patient Program for Lamprene (clofazimine) for the treatment of Non-Tuberculous Mycobacterial (NTM) Infections- CLAM320B2002M

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-H-0057

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

Lamprene;
Bronchiectasis;
Clofazimine;
Non-Tuberculous Mycobacteria

Recruitment Keyword(s)

None

Condition(s)

Bronchiectasis;
Non-Tuberculous Mycobacteria;
Leprosy;
Cardiac Arrhythmia

Investigational Drug(s)

Lamprene (clofazimine)

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

Background:

Non-tuberculous mycobacteria (NTM) are a group of many kinds of mycobacteria. They are common in soil and water. They usually do not cause disease in humans. But they can cause infection in people with lung problems. It is hard to treat NTM. Researchers want to see if a combination of medicines that includes the drug clofazimine (Lamprene) can help treat NTM.

Objectives:

To test the effectiveness of clofazimine (Lamprene) to treat non-tuberculous mycobacteria.

Eligibility:

Adults ages 18 99 who have NTM

Design:

Participants will be screened with:

Physical exam

Medical and psychiatric history

Review of medicines they are taking

Blood, liver, and heart tests

Participants must agree not to become pregnant or father a child while they are taking the study drug and for 4 months after stopping.

Participants will take the study drug 1 time each day by mouth with a meal.

Participants will have a visit with their doctor 2 4 months after starting the drug. Then they will have visits about every 6 months. They will repeat most of the screening tests.

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Eligibility

INCLUSION CRITERIA:

Patients eligible for inclusion in this program have to fulfill all of the following criteria:

1. Male or female patients 18 years of age or older

2. Written informed consent must be obtained before any project specific assessment is performed.

3. Patients previously diagnosed with NTM infection with local or disseminated infection (i.e. patients with any NTM species at any site of infection)

4. 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

5. 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

6. 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

Women of child-bearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopaus l is defined as 12 consecutive months with no menses without an alternative medical cause.

EXCLUSION CRITERIA:

Patients fulfilling any of the following criteria are not eligible for inclusion in this program:

1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine

2. 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)

3. 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

4. Confirmed demonstration of resting QTcF >500 msec at screening

5. Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe

6. Unable to swallow capsules

7. HIV-infected patients with disseminated NTM infection

8. Life expectancy less than 6 months

9. Pregnant or nursing (lactating) females


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kevin P. Fennelly, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 5-1421
10 CENTER DR
BETHESDA MD 20892
(301) 385-0807
kevin.fennelly@nih.gov

Chevalia Robinson, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 4-5350
10 Center Drive
Bethesda, Maryland 20892
(301) 496-3973
chevalia.robinson@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

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