OnchocerciasisPhase 3NCT02078024

Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana

A Phase 3 study testing IVM plus ALB and IVM in people with Onchocerciasis, run by University Hospitals Cleveland Medical Center at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to IVM alone given annually, which is the current standard for mass drug administration (MDA), is more effective in sterilizing adult worms. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Onchocerciasis
What is being tested?: IVM plus ALB and IVM
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 375 participants
Where: 1 siteGhana
Study dates: Jun 2014to 25 Jun 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana
Two or more assessable onchocercal nodules
Skin microfilaria density ≥5mf/mg.

Who cannot join

Prior treatment with the antifilarial and/or anti-nematodal drugs diethylcarbamazine, suramin, ivermectin, albendazole, levamisole or >1week of treatment with doxycycline, within 12 months before planned test article administration.
Pregnant or breastfeeding women.
Low probability of residency in the area (based on subject's assessment) over the next 36 months.
Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension
Weight of <40kg suggesting malnourishment
Hemoglobin levels <7 gm/dL

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aspartate aminotransferase, alanine aminotransferase, creatinine > 1.5 upper limit of normal.
Significant glycosuria or proteinuria (2+ or 3+ protein or glucose).
Known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.

Trial locations and contacts

1 site in 1 country.

Ghana1 site

Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital
Hohoe

Other trials in Ghana

About this study

Official title: Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.

Read the detailed description

We hypothesize that more effective combinations of dose schedules of existing antifilarial drugs for MDA against onchocerciasis could shorten the number of years needed to interrupt onchocerciasis transmission and eliminate this infectious disease in areas that previously had high disease rates. Improved treatments should also make it feasible to extend MDA into areas that are currently not being helped. These changes have the potential to completely change the game to make global elimination of onchocerciasis a feasible goal.

Participants will be randomized into 5 treatment arms with 75 subjects in each arm for a total of 375 and followed for 36 months after the initial treatment. The primary endpoint will be the percent fertile adult female worms in nodules removed 36 months after the initiation of treatment.

Conditions: Onchocerciasis
Being tested: IVM plus ALB, IVM
Keywords: Onchocerciasis
Medical subject headings: Onchocerciasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVM plus ALBDrug
IVMDrug

Study groups in NCT02078024
Study group	Role	What they receive
Annual Ivermectin	Active comparator	Ivermectin 200 µg/kg body weight given orally at 0, 12 and 24 months Receives: Drug: IVM
Biannual IVM 200 µg/kg plus ALB 800 mg	Experimental	IVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months. Receives: Drug: IVM plus ALB
Annual IVM 200 µg/kg plus ALB 800 mg	Experimental	IVM 200 µg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months. Receives: Drug: IVM plus ALB
Biannual IVM 200 µg/kg	Experimental	IVM 200 µg/kg given 0, 6, 12, 18, and 24 months. Receives: Drug: IVM
IVM 200 µg/kg plus ALB 400 mg	Experimental	IVM 200 µg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months. Receives: Drug: IVM plus ALB

What is being measured

The primary outcome is the main question the study is designed to answer.

parasitologic efficacy
To compare the parasitologic efficacy, as measured by percent fertile adult female worms in nodules at 36 months after administration of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvolus
Measured: 36 months

Secondary outcomes (6)

additional measures of parasitologic efficacy
To compare additional measures of parasitologic efficacy of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvulus as measured by skin microfilaria levels at additional time points.
Measured: 0, 6, 12, 18, 24 and 36 months
compare the percentage living versus dead female worms
To compare the percentage living versus dead female worms in nodules at 36 months following initiation of therapy of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvulus.
Measured: 36 months
compare the number of nodules with intact microfilaria
To compare the number of nodules with intact microfilaria (Mf) at 36 months after administration annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvulus.
Measured: 36 months
assess different treatment regimens on Soil Transmitted Helminth infections
To assess different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools.
Measured: 0, 6, 12, 18, 24 and 36 months
determine if IVM plus ALB enhances immunological reactions
To determine if IVM plus ALB enhances immunological reactions to adult worms antigens, or release of circulating parasite antigens as potential biomarkers of drug efficacy.
Measured: 0, 6, 12, 18, 24 and 36 months
determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae
To determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae. This can be accomplished by examining immune biomarkers prior to and following treatment using stored whole blood, and serum/plasma samples.
Measured: 0, 6, 12, 18, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201425 Jun 2018

First posted4 Mar 2014 (estimated)
Study startJun 2014
Primary completionJun 2018
Study completion25 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OnchocerciasisStudies of the same condition, open and under way.
More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 375 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02078024
Sponsor's protocol ID: WU-10-205
Other IDs: CWRU-OCR-1
Status last verified: Apr 2019
First submitted: 28 Feb 2014
Last updated: 26 Apr 2019
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
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All Onchocerciasis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.
ClinicalTrials.gov ID: NCT02078024
Acronym / sponsor ID: WU-10-205
Conditions: Onchocerciasis
Keywords: Onchocerciasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 375 participants (estimated)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Study start: Jun 2014
Primary completion: Jun 2018 (actual)
Study completion: 25 Jun 2018 (actual)
First posted: 4 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Annual Ivermectin	Active comparator	Drug: IVMIvermectin 200 µg/kg body weight given orally at 0, 12 and 24 months
Biannual IVM 200 µg/kg plus ALB 800 mg	Experimental	Drug: IVM plus ALBIVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months.
Annual IVM 200 µg/kg plus ALB 800 mg	Experimental	Drug: IVM plus ALBIVM 200 µg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months.
Biannual IVM 200 µg/kg	Experimental	Drug: IVMIVM 200 µg/kg given 0, 6, 12, 18, and 24 months.
IVM 200 µg/kg plus ALB 400 mg	Experimental	Drug: IVM plus ALBIVM 200 µg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana
Two or more assessable onchocercal nodules
Skin microfilaria density ≥5mf/mg.

Key exclusion criteria (9 listed)

Prior treatment with the antifilarial and/or anti-nematodal drugs diethylcarbamazine, suramin, ivermectin, albendazole, levamisole or >1week of treatment with doxycycline, within 12 months before planned test article administration.
Pregnant or breastfeeding women.
Low probability of residency in the area (based on subject's assessment) over the next 36 months.
Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension
Weight of <40kg suggesting malnourishment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IVM plus ALB	Drug	Annual IVM 200 µg/kg plus ALB 800 mg, Biannual IVM 200 µg/kg plus ALB 800 mg, IVM 200 µg/kg plus ALB 400 mg
IVM	Drug	Annual Ivermectin, Biannual IVM 200 µg/kg

Primary outcome

parasitologic efficacy
Time frame: 36 months
To compare the parasitologic efficacy, as measured by percent fertile adult female worms in nodules at 36 months after administration of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvolus

6 secondary outcomes

additional measures of parasitologic efficacy
Time frame: 0, 6, 12, 18, 24 and 36 months
compare the percentage living versus dead female worms
Time frame: 36 months
compare the number of nodules with intact microfilaria
Time frame: 36 months
assess different treatment regimens on Soil Transmitted Helminth infections
Time frame: 0, 6, 12, 18, 24 and 36 months
determine if IVM plus ALB enhances immunological reactions
Time frame: 0, 6, 12, 18, 24 and 36 months
determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae
Time frame: 0, 6, 12, 18, 24 and 36 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.

Related trials for Onchocerciasis

Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Active, not recruitingPhase 3
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
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Active, not recruitingPhase 2
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
Onchocercal Subcutaneous Nodule, Onchocerciasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher L King, MD, PhD principal investigator

Case Western Reserve University

James W Kazura, MD principal investigator

Case Western Reserve University

Nicholas O Opoku, MBChB, MSc principal investigator

Municipal Hospital, Hohoe, Ghana

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IVM plus ALB and IVM in people with Onchocerciasis, run by University Hospitals Cleveland Medical Center at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

parasitologic efficacy (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.