Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa (NCT02644525) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa
Stopped: Planned interim analysis demonstrated futility of intervention
Cameroon20 participantsStarted 2019-09-16
Plain-language summary
Background:
Many people who live in west or central Africa are at risk for infection from a very small worm called Loa loa. This infection is acquired through the bite of a fly. Baby worms called microfilariae live in the blood. The infection most commonly causes skin itching, mild temporary limb swelling, and sometimes a adult worm can be seen in the white of the eye of an infected individual. Very rarely, people with this infection can develop problems with the kidneys and heart as a result of the worm's effect on the immune system. Because the vast majority of people with the infection have minimal symptoms, people in Cameroon usually do not get treated. But infection with Loa loa can cause serious problems in people who are being treated for infections with other parasites (namely, river blindness and lymphatic filariasis). Researchers want to find out of a drug called imatinib can treat Loa loa infection so that patients with this infection can safely receive other drugs to cure river blindness and lymphatic filariasis. Researchers believe imatinib can be a safe drug to use on Loa loa, because in the lab this drug kills the worms slowly, whereas other drugs which can cause treatment reactions usually kill the worms very quickly.
Objective:
To test if imatinib can treat Loa loa infection by killing the worms slowly.
Eligibility:
People ages 18-65 with non-severe Loa loa infection who are otherwise healthy
Design:
Participants will be screened with a physical exam and blood and urine tests.
Participants will have a baseline visit. This will include a physical exam and blood and urine tests. It may include a stool sample. Participants will be randomly assigned to get 1 dose of either imatinib or a placebo.
Participants will return to the clinic every day for 1 week, then once a week for 3 weeks. Visits will include a physical exam and blood tests. They will have urine tests in the first week.
Participants will have follow-up visits 3, 6, and 12 months after taking the imatinib or placebo. These include a physical exam and blood tests. They may include urine and stool samples.
If participants develop side effects, they will be treated for them.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age greater than or equal to 18 years old and less than or equal to 65 years
. Loa loa microfilaremia \>500 MF/mL and \<2500 MF/mL at screening visit.
. Subject has the capacity to understand the potential risks and benefits and consents to protocol indicated blood draws and follow up visits.
Exclusion criteria
. Women under 45 years of age, or over 45 years of age with a menstrual period in the preceding 12 months.
. Currently breastfeeding
. Currently taking daily medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of Baseline Loa Loa Microfilariae
Timeframe: Days 1-7, 14, 21
Trial details
NCT IDNCT02644525
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Known chronic medical conditions, including but not limited to diabetes, renal failure, liver disease, seizure disorder, HIV, malignancy, psychiatric disorder, or any conditions which within the investigators judgement are deemed to be clinically significant.
. W. bancrofti serologic positivity against Wb123
. O. volvulus serologic positivity against Ov16
. HIV by history or clinical signs of HIV/AIDS (e.g. oral thrush, oral/skin lesions of Kaposi s sarcoma, etc.)
. Any of the following lab abnormalities: Creatinine \>1.5, Platelets \<100,000/mL, Hemoglobin \<12g/dL, alanine aminotransferase or aspartate aminotransferase \>60 U/L, total bilirubin \>1.7mg/dL, absolute neutrophil count equal to or less than 1500/mm(3).