Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients

NCT03084952 | Unknown Phase 2

• 1 other identifier: HB/F2-002/2016
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.

Conditions

Leishmaniasis; American, Cutaneous; Drug Side Effect

Keywords

safety; pharmacokynetics; leishmaniasis treatment

Outcome Measures

Primary Outcomes (3)

• Lesion Reduction and Re-epithelization - Definitive Cure

  complete epithelization of all ulcers and complete disappearance of inflammatory hardening of all lesions at 6 months at the follow-up visit.

  6 months at the follow-up visit.

• Lesion Reduction and Re-epithelization - Partial Cure

  incomplete epithelialization or incomplete regression of inflammatory hardening of one or more lesions, and without the appearance of new lesions. Apparent cure: complete epithelization of all ulcers and regression ≥ 70% of the inflammatory hardening of all lesions.

  6 months at the follow-up visit.

• Clinical Failure

  Any of the following topics as clinical failure: residual readers with the presence of non-GiemsaDiff-Quick print parasites, or the appearance of new lesions or ≥ 20% increase or no improvement of lesions previously documented.

  6 months at the follow-up visit.

Study Arms (7)

1 mg/day

EXPERIMENTAL

Drug: 18-Methoxycoronaridine

4 mg/day

EXPERIMENTAL

Drug: 18-Methoxycoronaridine

8 mg/day

EXPERIMENTAL

Drug: 18-Methoxycoronaridine

12 mg/day

EXPERIMENTAL

Drug: 18-Methoxycoronaridine

Glucantime

ACTIVE COMPARATOR

Drug: Glucantime

Best dose 18-MC

EXPERIMENTAL

Drug: 18-Methoxycoronaridine

Minimum effective dose 18-MC

EXPERIMENTAL

Drug: 18-Methoxycoronaridine

Interventions

18-Methoxycoronaridine DRUG

Drug under evaluation for leishmaniasis treatment

1 mg/day; 12 mg/day; 4 mg/day; 8 mg/day; Best dose 18-MC; Minimum effective dose 18-MC

Glucantime DRUG

Leishmaniasis standard drug in Brazil

Glucantime

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 59 years of age;
• Clinical diagnosis of leishmaniasis with at least one ulcerated lesion with evolution time from one month;
• Parasitological confirmation;
• Women of childbearing potential should not be pregnant or breastfeeding, confirmed by examination of b-HCG (Gonadotrophic-Chorionic Hormone beta) at the time of screening;
• Men and women should use barrier contraceptive methods during the course of the study;

You may not qualify if:

• History of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study;
• History or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product;
• Any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary);
• Pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy;
• History of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion;
• Any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator;
• Any positive screening result for hepatitis B antigens, hepatitis C antibodies, and human immunodeficiency virus (HIV);
• Any clinically significant abnormalities in the rate, or driving the resting ECG morphology that may interfere with the interpretation of the QT interval variations;
• History of cancer;
• History of drug abuse, judging by the investigator
• History of alcohol abuse or excessive alcohol consumption, judged by the investigator;
• History of smoking
• History of severe allergy / hypersensitivity, judged by the investigator;
• History of hypersensitivity to drugs with similar chemical structure.

Sponsors & Collaborators

• Infan Industria Quimica Farmaceutica Nacional: lead

MeSH Terms

Conditions

Leishmaniasis, Mucocutaneous; Drug-Related Side Effects and Adverse Reactions

Interventions

18-methoxycoronaridine; Meglumine Antimoniate

Condition Hierarchy (Ancestors)

Leishmaniasis, Cutaneous; Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates

Central Study Contacts

Jan Carlo Delorenzi, PhD

CONTACT

+55(11)989780869; jancarlo@hebron.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 21, 2017
• Study Start: May 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: March 19, 2020

Record last verified: 2020-03