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

Expanded access is currently available for this treatment.
Verified August 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01931085
First received: August 22, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Parasitic Disease
Drug: Triclabendazole

Study Type: Expanded Access     What is Expanded Access?
Official Title: "Compassionate Use of Triclabendazole for the Treatment of Parasites" (Prior to FDA Approval; Expanded Access Program)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Intervention Details:
    Drug: Triclabendazole
    Triclabendazole (10 mg/kg body-weight as a single dose).
    Other Name: Egaten
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931085

Contacts
Contact: Marilyn Levi, MD 720-848-0817 MARILYN.LEVI@UCDENVER.EDU

Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01931085     History of Changes
Other Study ID Numbers: 11-1438
Study First Received: August 22, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parasitic Diseases
Triclabendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014