CClinicalTrials.gg
No longer availableNCT01931085Updated May 4, 2021

Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)

An expanded access record providing Triclabendazole in Parasitic Disease, sponsored by University of Colorado, Denver. No longer available. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by University of Colorado, Denver · Expanded access

Study type
Expanded access
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary practice. Triclabendazole is considered to be a second-line drug for parasites and is used when other preferred agents cannot be used because they are ineffective or because adverse reactions limit their use. Although Triclabendazole is widely used in developing countries for the treatment of parasites it is not approved by the FDA for this treatment in the US. It is currently being distributed in the US through a special arrangement with the FDA and the manufacturer on an individual patient approval basis. This arrangement requires that a single patient Investigational New Drug (IND) be obtained from FDA for each patient requiring Triclabendazole. Upon approval by FDA, the manufacturer (Novartis) will ship the drug directly to the prescribing physician.

02

Conditions studied

  • Parasitic Disease

Browse trials for

03

In context

Parasitic Diseases

62 studies on the registry are indexed under Parasitic Diseases; 13 are open to participants now.

Browse Parasitic Diseases studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All

Inclusion criteria

  • Patients with a diagnosis of parasites whose resistance pattern has indicated resistance to first line agents and sensitivity to Triclabendazole or in whom an additional drug needs to be added to their regimen because of inadequate response to existing therapy.
  • Patients with a parasite that is sensitive to Triclabendazole and who have experienced an allergic or adverse reaction to other agents that prevent their use.
  • Patients with parasitic disease that has responded to treatment with first line drugs but who experienced allergic or adverse reactions to these agents that has prevented their continued use or who have experienced a relapse in their disease that necessitates the addition, or substitution, of second-line agents
  • Patients who do not qualify for a study using Triclabendazole or for whom a study does not exist and thus the patient would not otherwise have access to the drug

Exclusion criteria

Exclusion Criteria:

  • Anyone whose parasitic disease can be adequately treated by other available medications.
  • Anyone who is allergic or who has had a severe adverse reaction to Triclabendazole in the past.
  • Pregnant Women
05

Access details

Study type
Expanded access

Available treatment

  • DrugTriclabendazole

    Triclabendazole (10 mg/kg body-weight as a single dose).

    Also known as: Egaten

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01931085
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Aug 29, 2013
Last update
May 4, 2021

Study contacts

Marilyn Levi, MD
principal investigator · University of Colorado, Denver
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion