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  4. Drug Trials Snapshots: LAMPIT
  1. Development & Approval Process | Drugs

Drug Trials Snapshots: LAMPIT

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to LAMPIT Prescribing Information for complete information.

LAMPIT (nifurtimox)
LAM-pit
Bayer HealthCare Pharmaceuticals Inc.
Approval date: August 6, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

LAMPIT is a drug used to treat Chagas disease in children less than 18 years of age.

Chagas disease is an infectious disease caused by a parasite (Trypanosoma [T.] cruzi). After years of infection, the parasites may cause serious and sometimes deadly heart conditions as well as serious gut and nerve damage.

How is this drug used?

LAMPIT is a tablet. It is taken by mouth three times a day with food for 60 days. Total daily dose is determined by the child’s weight.

What are the benefits of this drug?

The benefit of LAMPIT was measured by the number of patients who had a change in the antibodies to T. cruzi parasite (called serologic response). In the trial, 32% of patients who received LAMPIT for 60 days had serologic response after one year.

LAMPIT was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: LAMPIT worked similarly in males and females.
  • Race: Most of the patients were White. Differences in how well LAMPIT worked among races could not be determined.
  • Age: Differences in how well LAMPIT worked among age groups could not be determined.

What are the possible side effects?

LAMPIT can cause serious reactions including worsening of neurologic and mental conditions, severe allergic reactions, weight loss, and possible harm to the developing fetus.

Common side effects of LAMPIT are vomiting, abdominal pain, headache, decreased appetite, nausea, fever, and rash.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: Most of the patients were White. Differences in side effects by race could not be determined.
  • Age: The occurrence of side effects was similar in tested age groups.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved LAMPIT based on evidence from the one clinical trial (Trial 1/NCT02625974) of 219 children with Chagas disease. Trial was conducted at 25 sites in Argentina, Bolivia and Colombia. Demographics of this trial are presented in the figures below.

Figure 1 summarizes by sex how many children were in the clinical trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 119 women (54%) and 100 men (46%) participated in the clinical trial.

FDA Review

Figure 2 summarizes by race how many children were in the clinical trial.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 155 White (71%) 64 (29%) American Indian or Alaska Native

FDA Review

Figure 3 summarizes how many patients of certain age were in the clinical trial.

Figure 3. Baseline Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  29 (13%) were less than 2 years and 190 (87%) patients were 2 - 18 years and older.

FDA Review

Figure 4 summarizes by ethnicity how many children were in the clinical trial.

Figure 4. Baseline Demographics by Ethnicity

Pie charts summarizing ethnicity of patients enrolled in the clinical trial. In total,  217 patients were Hispanic or Latino (98%) and 2 patients were not Hispanic or Latino (2%).

FDA Review

How were the trials designed?

There was one trial that provided data for the assessment of benefit and side effects of LAMPIT.

In the trial, children less than 18 years of age with Chagas disease and without symptoms of heart or gastrointestinal disease were randomly treated with LAMPIT tablets three times a day for 60 days. Patients were followed for 1 year.

The benefit of LAMPIT was evaluated at the end of follow-up by measuring antibodies to the parasite in the blood.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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