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

NCT01931085 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-05-04

No results posted yet for this 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.

Conditions

  • Parasitic Disease

Interventions

DRUG

Triclabendazole

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

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Marilyn Levi, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01931085 on ClinicalTrials.gov