Parasitic DiseaseNCT01931085
Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)
A study testing Triclabendazole in people with Parasitic Disease, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parasitic Disease
- What is being tested?
- Triclabendazole
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 99 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: "Compassionate Use of Triclabendazole for the Treatment of Parasites" (Prior to FDA Approval; Expanded Access Program)
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
- Being tested
- Triclabendazole
- Medical subject headings
- Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriclabendazoleDrug
Also called Egaten
Triclabendazole (10 mg/kg body-weight as a single dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasitic DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyn Levi, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931085
- Sponsor's protocol ID
- 11-1438
- Status last verified
- Apr 2021
- First submitted
- 22 Aug 2013
- Last updated
- 4 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Compassionate Use of Triclabendazole for the Treatment of Parasites" (Prior to FDA Approval; Expanded Access Program)
- ClinicalTrials.gov ID
- NCT01931085
- Acronym / sponsor ID
- 11-1438
- Conditions
- Parasitic Disease
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- First posted
- 29 Aug 2013 (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.
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.
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| TriclabendazoleAlso: EgatenTriclabendazole (10 mg/kg body-weight as a single dose). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
Marilyn Levi, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Triclabendazole in people with Parasitic Disease, run by University of Colorado, Denver.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 4 May 2021.