LXE408 treatment for visceral leishmaniasis in Ethiopia
A Randomized, Open-label, Phase II, Single-centre Study to Evaluate the Efficacy, Safety and Pharmacokinetics of LXE408 in Patients With Primary Visceral Leishmaniasis in Ethiopia
This study is testing a new treatment called LXE408 for adults with visceral leishmaniasis in Ethiopia to see if it works better than the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Sponsor | Drugs for Neglected Diseases Academic / other |
| Locations | 1 site (Gondar) |
| Trial ID | NCT05957978 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, open-label, phase II study that aims to evaluate the efficacy of LXE408 in treating primary visceral leishmaniasis in adults aged 18 to 45 years in Ethiopia. Participants will be randomly assigned to receive either LXE408 orally for 14 days or the standard treatment of sodium stibogluconate combined with paromomycin for 17 days. The study will involve a screening period, treatment duration, and follow-up assessments to monitor patient outcomes and potential cure rates. Approximately 52 patients will be enrolled, and the study will be conducted at the University of Gondar.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female adults aged 18 to 45 years with confirmed primary visceral leishmaniasis.
Not a fit: Patients with severe clinical signs of visceral leishmaniasis or significant laboratory abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and potentially safer option for patients suffering from visceral leishmaniasis.
How similar studies have performed: While this approach is novel in the context of visceral leishmaniasis treatment, other studies have explored similar drug regimens with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients ≥18 and \<45 years (at the time of the screening visit) who are able to comply with the study protocol * Written informed consent must be obtained before any study protocol specific assessment is performed, other than procedures performed as part of standard of care * Primary symptomatic VL (defined as typical parameters including, but not limited to, fever for \>2 weeks, weight loss and splenomegaly) * Visualization of Leishmania amastigotes by microscopy in tissue samples (spleen or bone marrow) Exclusion Criteria: * Clinical signs of severe VL (including for example jaundice, spontaneous bleeding, oedema, ascites, coma, organ failure) * Laboratory abnormalities including ALT/SGPT \>3 times ULN, total bilirubin \>1.5 times ULN, creatinine \>1.5 times ULN, serum amylase or lipase \>1.5 times ULN, haemoglobin \<6 g/dL or other clinically significant abnormal laboratory parameters which, in the opinion of the investigator, may indicate severe VL * Patients with history of visceral leishmaniasis and confirmed relapse * Patients with para-kala-azar dermal leishmaniasis * Patients with severe malnutrition (Mid-Upper Arm Circumference (MUAC) \<170 mm) * History of congenital or acquired immunodeficiency, including positive HIV (test at screening), as these patients present lower efficacy rates, higher toxicity and higher lethality compared to non-HIV patients, requiring different case management and care * ECG abnormalities, either historic (no longer present) or current which, in the view of the investigator, indicate a significant risk to study participation. These include, but are not limited to, the following: 1. Clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia and clinically significant second- or third-degree AV block without a pacemaker) 2. QTcF ≥ 450 ms 3. History of familial long QT syndrome or known family history of Torsades de Pointes 4. Resting heart rate (physical exam or 12 lead ECG) \<60 bpm * Concomitant known infections, including tuberculosis, severe malaria and any other serious underlying disease that may interfere with disease assessment (e.g., cardiac, renal, hepatic, haematologic and pancreatic) * Infection with hepatitis B (HBV) or hepatitis C virus (HCV). Patients with a positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, and patients with a positive HCV antibody test must be excluded and will be followed up as per local practice. * Known history of hearing impairment and/or clinical signs and symptoms of hearing impairment identified during routine physical examination * Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments or excipients * Pregnant or nursing (lactating) women * Women of childbearing potential who do not agree to have a pregnancy test done at screening and who do not agree to use highly effective contraception while taking the investigational drug and for 5 days after stopping the investigational drug * Sexually active males unwilling to use a condom during intercourse while taking the investigational drug and for 5 days after stopping the investigational drug * Patients who cannot comply with the planned scheduled visits and procedures of the study protocol
Where this trial is running
Gondar
- University of Gondar — Gondar, Ethiopia (Recruiting)
Study contacts
- Principal investigator: Mezgebu Silamsaw, Dr — University of Gondar, Ethiopia
- Study coordinator: Alexandra Solomos
- Email: asolomos@dndi.org
- Phone: + 41 22 906 92 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.