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Clinical Trials/NL-OMON45838
NL-OMON45838
Recruiting
Phase 2

Treatment of congenital vascular malformations using Sirolimus: improving quality of Life - Treatment of congenital vascular malformations with Sirolimus

Radboud Universitair Medisch Centrum0 sites75 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
75
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of Congenital venous malformation, or lymphatic malformation or combined.
  • •Age between 1\-70 years.
  • •Patients (or legal guardians for children) have to be able to sign the informed consent
  • •Patients are either refractory to standard care such as medical treatment (low molecular weight heparines, pain medication etc.), surgical resection and/or sclerotherapy/embolization (ineffective or accompanied by major complications) or there is no possibility for surgical intervention anymore. Only patients that have a normal clinical screening (no signs for infection, normal bone marrow function, normal liver and kidney function, normal glucose metabolism etc.) can be included.
  • •Patients included have no cardiac impairment
  • •Patients have no gastrointestinal impairment as Sirolimus is absorbed gastro\-intestinal and normal function is needed
  • •No other underlying medical disorder like Down syndrome or other syndromes
  • •Women of reproductive age have to be informed that contraceptive methods are
  • •mandatory during the study time, pregnant women are excluded as also breast\-feeding women
  • •Karnofsky score \> 50

Exclusion Criteria

  • •No written informed consent
  • •Known hypersensitivity to drugs or metabolites from similar classes as study
  • •Patient has other concurrent severe and /or uncontrolled medical condition that would, in the investigator\*s judgment, contraindicated participation in the clinical study (e.g. acute or chronic pancreatitis, liver cirrhosis, active chronic hepatitis, severely impaired lung function with a spirometry \<\= 50% of the normal predicted value and/or O2 saturation \<\= 88% at rest, etc.)
  • •Recent history of primary malignancy \<\= 5 years
  • •Impaired cardiac function or clinically significant cardiac diseases
  • •Immunocompromised patients, including known seropositivity for HIV
  • •Patient with any other concurrent severe and /or uncontrolled medical condition that
  • •would,in the investigator\*s judgment, contraindicated participation in the clinical
  • •Pregnant or lactating women
  • •Karnofsky score \< 50

Outcomes

Primary Outcomes

Not specified

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