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Lymphatic FilariasisPhase 2NCT01975441

Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa

A Phase 2 study testing Diethylcarbamazine, Albendazole and Ivermectin in people with Lymphatic Filariasis, run by University Hospitals Cleveland Medical Center at 1 site in Papua New Guinea.

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

This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Lymphatic Filariasis
What is being tested?
Diethylcarbamazine, Albendazole and Ivermectin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 sitePapua New Guinea
Study dates
May 2014to Jun 2018
Phase
Phase 2
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women 18-65 years
  • >50 mf/ml in finger stick blood samples
  • Willing to give informed consent

Who cannot join

  • Prior treatment for LF within last 5 years
  • Pregnant (do pregnancy test)
  • Hemoglobin < 7 g/dl
  • permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension
  • AST/ALT and creatinine > 1.5 upper limit of normal.
  • Urine dipstick with glucose ≥ 2+ and/or protein ≥ 2+

Trial locations and contacts

1 site in 1 country.

Papua New Guinea1 site

  • Papua New Guinean Institute for Medical Research

    Maprik, East Sepik Province

Other trials in Papua New Guinea

About this study

Official title: Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa

This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.

Read the detailed description

This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.

There will be 3 treatment arms as follows:

  1. The comparator (standard treatment) DEC 6 mg/kg + Alb 400 mg administered annually (at 0, 12, and 24 months).
  2. DEC 6 mg/kg + Alb 400 mg given once
  3. DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).
Being tested
Diethylcarbamazine, Albendazole, Ivermectin
Keywords
Diethycarbamazine, Albendazole, Ivermectin, Lymphatic filariasis
Medical subject headings
Elephantiasis, Filarial

What participants receive

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

  • DiethylcarbamazineDrug

    Also called DEC

    Diethylcarbamazine 6mg/kg

  • AlbendazoleDrug

    Also called ALB, Albenda

    Albendazole 400mg

  • IvermectinDrug

    Also called IVM, Stromectol

    Ivermectin 200 mcg/kg

Study groups in NCT01975441
Study groupRoleWhat they receive
standard treatmentActive comparatorDiethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).
Receives: Drug: Diethylcarbamazine; Drug: Albendazole
DEC 6 mg/kg + Alb 400 mg x 1ExperimentalDiethylcarbamazine 6 mg/kg + Albendazole 400 mg given once
Receives: Drug: Diethylcarbamazine; Drug: Albendazole
DEC + ALB + IVMExperimentalDiethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
Receives: Drug: Diethylcarbamazine; Drug: Albendazole; Drug: Ivermectin

What is being measured

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

  1. Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)

    Measured: at 36 months

Secondary outcomes (3)

  1. Percentage of subjects with total clearance of Mf at 24 months.

    Measured: 24 months

  2. Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months

    Measured: 24 months and 36 months

  3. Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study

    Measured: 24 months and 36 months

Timeline

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

  1. First posted4 Nov 2013 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2017
  4. Study completionJun 2018

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01975441
Sponsor's protocol ID
CWRU 3 vs 2 LF ELIM PNG
Status last verified
Oct 2018
First submitted
28 Oct 2013
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • King CL, Suamani J, Sanuku N, Cheng YC, Satofan S, Mancuso B, Goss CW, Robinson LJ, Siba PM, Weil GJ, Kazura JW. A Trial of a Triple-Drug Treatment for Lymphatic Filariasis. N Engl J Med. 2018 Nov 8;379(19):1801-1810. doi: 10.1056/NEJMoa1706854.

    PubMed 30403937

  • Thomsen EK, Sanuku N, Baea M, Satofan S, Maki E, Lombore B, Schmidt MS, Siba PM, Weil GJ, Kazura JW, Fleckenstein LL, King CL. Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis. Clin Infect Dis. 2016 Feb 1;62(3):334-341. doi: 10.1093/cid/civ882. Epub 2015 Oct 20.

    PubMed 26486704

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diethylcarbamazine, Albendazole and Ivermectin in people with Lymphatic Filariasis, run by University Hospitals Cleveland Medical Center at 1 site in Papua New Guinea.

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 6 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 9 Oct 2018. 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 Papua New Guinea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) (time frame: at 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 NCT01975441, which also lists 2 linked publications.

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 9 Oct 2018.

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