NL-OMON48255
Completed
Phase 2
An uncontrolled, open label pilot-study assessing the efficacy in reducing bleeding severity, and the safety of oral tacrolimus in patients with hereditary hemorrhagic telangiectasia - Tacrolimus for bleeding in HHT patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Patients with HHT:
- •o Definite HHT according to the Curacao criteria (3 positive criteria or more)
- •o Genetically confirmed HHT
- •\* Suffering from epistaxis at least on average of 4 days per week or documented
- •gastrointestinal teleangiectasis by endoscopy with suspicion of bleeding;
- •\* In the last six months suffering from anemia, iron deficiency or use iron
- •treatment or blood transfusions;
- •\* Failure or partial failure of local treatment with systemic treatment
- •indicated by ENT specialist or gastroenterologist;
- •\* Adult (18 years or older at time of inclusion).
Exclusion Criteria
- •\* Hypersensitivity or allergy for tacrolimus
- •\* Patients with a severe disease with a life\-expectancy \<1 year;
- •\* Women that are pregnant, nursing, have a pregnancy wish in the study period
- •or who use anticonception inadequately;
- •\* Patients currently receiving chemotherapy;
- •\* Severe kidney disease
- •\* History of severe ventricular cardiac dysfunction
- •\* A negative advise of a clinical pharmacist in cases with concurrent use of
- •drugs that have a clinically relevant interaction with tacrolimus.
- •\* Patients who do not understand English or Dutch language sufficiently enough;
Outcomes
Primary Outcomes
Not specified
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