Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004639229710 Date of Approval: 17/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
Official scientific title A randomized, double blind, parallel trial in the Democratic Republic of Congo (DRC) comparing the safety and efficacy of annual or biannual doses of moxidectin or ivermectin for treatment of onchocerciasis
Brief summary describing the background and objectives of the trial The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness. Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Onchocerciasis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2021
Actual trial start date 03/05/2021
Anticipated date of last follow up 31/07/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants) 323
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
MDGH MOX 3001 Medicines Development for Global Health
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Annual Moxidectin 8 mg per oral, taken annually 24 months Moxidectin 2 mg tablets (4x), taken orally 375
Experimental Group Biannual Moxidectin 8 mg per oral, taken biannually 24 months Moxidectin 2 mg tablets (4x), taken orally 375
Experimental Group Biannual Ivermectin Approximately 150 μg/kg per oral, taken biannually 24 months Ivermectin 3 mg tablets (approximately 150 μg/kg per oral), taken orally 125
Control Group Annual Ivermectin Approximately 150 μg/kg per oral, taken annually 24 months Ivermectin 3 mg tablets (approximately 150 μg/kg per oral), taken orally 125 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Provision of written informed consent, or assent with parental or guardian written consent. 2. Mean ≥ 10 O. volvulus mf/mg skin, determined by four skin snips. 3. Living in a village selected for the study. 4. Age ≥ 12 years. 5. All female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product. 1. Pregnant or breast-feeding. 2. Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health. 3. Has received ivermectin, oral diethylcarbamazine (DEC) or doxycycline (for > 2 weeks) within 6 months of Baseline. 4. Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline. 5. Known or suspected allergy to ivermectin or moxidectin or their excipients. 6. Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations. 7. Weight > 88 kilograms. 8. Infection with Loa loa. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 999 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/08/2020 National Committee of Health Ethics
Ethics Committee Address
Street address City Postal code Country
Local 5, 1er niveau, Immeuble PNMLS C/ Kasa-Vubu Kinshasa 0000 Democratic Republic of the Congo
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/09/2020 World Health Organization Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
World Health Organization 20 Appia Avenue Geneva 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of full analysis set participants in the moxidectin annual and biannual treatment arms with zero O. volvulus skin microfilariae at both Months 6 and 12; microfilaridermia is determined by the count of four skin snips for each participant at each assessment Months 6 and 12
Primary Outcome Safety across all dose groups will be evaluated by the incidence and severity of adverse events (AEs) and measurement of vital signs up to and including Month 36 and liver function tests up to and including Month 12. Months 6, 12, 18, 24, 30 and 36
Secondary Outcome Sustained microfilariae response, defined as zero O. volvulus skin microfilariae sustained at all post-Baseline assessments Months 12, 18, 24, 30 and 36
Secondary Outcome Sustained ocular microfilariae response, defined as zero live O. volvulus microfilariae in the anterior chambers of the eyes at all post-Baseline assessments in those with live microfilariae in the anterior chambers of the eyes before the first treatment Months 12, 18, 24, 30 and 36
Secondary Outcome Mean and median percent reduction (from pre-treatment) of skin microfilariae density and live microfilariae in the anterior chambers of the eyes Months 6, 12, 18, 24, 30 and 36
Secondary Outcome The proportion of participants in each treatment group with zero skin microfilariae and zero live microfilariae in the anterior chambers of the eyes at each post-Screening assessment Months 6, 12, 18, 24, 30 and 36
Secondary Outcome Mean skin microfilariae density at each post-Screening assessment and the mean and mean change from baseline, for the number of live microfilariae in the anterior chambers of the eyes at each post-Screening assessment in those with live microfilariae in the anterior chambers of the eyes before the first treatment Months 6, 12, 18, 24, 30 and 36
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherche en Maladies Tropicales Hopital General de Reference de Rethy Rethy 0000 Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trial Partnership Anna van Saksenlaan 51 The Hague 2593 Netherlands
Medicines Development for Global Health Level 1, 18 Kavanagh Street Southbank 3006 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medicines Development for Global Health Level 1, 18 Kavanagh Street Southbank 3006 Australia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tony Ukety tony.ukety@gmail.com +243822400101 Hopital General de Reference de Rethy
City Postal code Country Position/Affiliation
Rethy 0000 Democratic Republic of the Congo Principal Investigator
Role Name Email Phone Street address
Public Enquiries Sally Kinrade sally.kinrade@medicinesdevelopment.com +61399122400 Level 1, 18 Kavanagh Street
City Postal code Country Position/Affiliation
Southbank 3006 Australia Moxidectin for Onchocerciasis Project Leader
Role Name Email Phone Street address
Scientific Enquiries Sally Kinrade sally.kinrade@medicinesdevelopment.com +61399122400 Level 1, 18 Kavanagh Street
City Postal code Country Position/Affiliation
Southbank 3006 Australia Moxidectin for Onchocerciasis Project Leader
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data to be shared: anonymised demographic, baseline data and primary and secondary outcomes Clinical Study Report Following finalisation of the Clinical Study Report and initial publications, anticipated Q4, 2025 Controlled access. Requests anticipated from researchers. Decision made by Sponsor in consultation with site, on the following criteria: quality/purpose of request, and mutual agreement regarding publication planning and confidentiality provisions.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information