Your session is about to expire
← Back to Search
mTOR inhibitor
Sirolimus for Nosebleeds in HHT
Phase 2
Recruiting
Led By Marie E Faughnan, MD MSc FRCPC
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Epistaxis at least 15 min per week
COVID-19 Vaccine (2 doses)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial is testing if the drug sirolimus can help people with HHT who have moderate or severe nosebleeds. The study will last 3 months, and people will take sirolimus once a day.
Who is the study for?
This trial is for adults over 18 with Hereditary Hemorrhagic Telangiectasia (HHT) who suffer from moderate to severe nosebleeds lasting at least 15 minutes per week. Participants must have received two COVID-19 vaccine doses and not be pregnant, breastfeeding, or planning pregnancy without effective contraception. They should not have a history of cancer, acute infections, unstable illnesses, high creatinine levels, liver issues twice above normal limits or untreated dyslipidemia.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of oral sirolimus in reducing nosebleeds in HHT patients. Participants will take a daily dose of sirolimus to maintain specific blood levels for three months. The impact on nosebleeds will be measured against their situation before the trial using patient-reported outcomes.See study design
What are the potential side effects?
Sirolimus may cause side effects such as mouth sores, diarrhea, nausea, lower blood cell counts increasing infection risk; it can also affect kidney function and cholesterol levels. Side effects vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience nosebleeds lasting over 15 minutes each week.
Select...
I have received 2 doses of a COVID-19 vaccine.
Select...
I am older than 18 years.
Select...
I have been diagnosed with HHT either through clinical evaluation or genetic testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood glucose level
Electrolytes
Hematology
+4 moreSecondary outcome measures
Biomarkers
Epistaxis
Side effects data
From 2008 Phase 4 trial • 293 Patients • NCT0011874229%
Diarrhoea
18%
Abdominal Pain
16%
Nausea
16%
Headache
16%
Fatigue
16%
Hepatitis C
14%
Vomiting
14%
Pyrexia
14%
Leukopenia
12%
Oedema Peripheral
11%
Insomnia
10%
Anaemia
10%
Hyperkalaemia
10%
Tremor
10%
Back Pain
10%
Hypertension
9%
Cough
9%
Pruritis
9%
Arthralgia
8%
Neutropenia
8%
Abdominal Pain Upper
8%
Dizziness
8%
Pain in Extremity
8%
Hepatic Enzyme Increased
7%
Dyspnoea
7%
Constipation
7%
Sinusitis
7%
Weight Decreased
6%
Blood Creatinine Increased
6%
Liver Function Test Abnormal
6%
White Blood Cell Count Decreased
5%
Jaundice
5%
Renal Failure
5%
Muscle Spasms
5%
Decreased Appetite
5%
Weight Increased
5%
Upper Respiratory Tract Infection
5%
Nasopharyngitis
5%
Asthenia
5%
Incision Site Pain
5%
Depression
4%
Anorexia
4%
Night Sweats
4%
Oropharyngeal Pain
4%
Rhinorrhoea
3%
Myalgia
3%
Pleural Effusion
3%
Hyperlipidaemia
3%
Thrombocytopenia
3%
Rash
3%
Acne
3%
Incisional Hernia
2%
Sepsis
2%
Pneumonia
2%
Hypokalaemia
1%
Cerebral Haemorrhage
1%
Gastritis
1%
Urinary Retention
1%
Abdominal Hernia
1%
Multi-Organ Failure
1%
Ventricular Tachycardia
1%
Renal Failure Acute
1%
Hypoglycaemia
1%
Benign Prostatic Hyperplasia
1%
Non-Small Cell Lung Cancer Metastatic
1%
Crohn's Disease
1%
Clostridium Difficile Colitis
1%
Hepatic Neoplasm Malignant
1%
Hepatic Failure
1%
Chest Pain
1%
Blood Alkaline Phosphatase Increased
1%
Inappropriate Antidiuretic Hormone Secretion
1%
Gastrointestinal Haemorrhage
1%
Cardiac Failure Congestive
1%
Hepatic Artery Stenosis
1%
Portal Vein Thrombosis
1%
Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%
Gastrointestinal Tract Adenoma
1%
Febrile Neutropenia
1%
Encephalopathy
1%
Atrial Flutter
1%
Blood Glucose Increased
1%
Transplant Rejection
1%
Confusional State
1%
Spinal Osteoarthritis
1%
Hypercholesterolaemia
1%
Convulsion
1%
Peritonitis
1%
Haemorrhage Intracranial
1%
Deep Vein Thrombosis
1%
Inguinal Hernia
1%
Viral Infection
1%
Acarodermatitis
1%
Atrial Fibrillation
1%
Malaise
1%
Hepatic Cancer Metastatic
1%
Adenocarcinoma
1%
B-Cell Lymphoma
1%
Desmoid Tumour
1%
Pulmonary Embolism
1%
Stomatitis
1%
Influenza
1%
Staphylococcal Infection
1%
Umbilical Hernia
1%
Hepatic Function Abnormal
1%
Hyponatraemia
1%
Bacteraemia
1%
Cellulitis
1%
Clostridial Infection
1%
Diverticulitis
1%
Escherichia Urinary Tract Infection
1%
Lactobacillus Infection
1%
Lobar Pneumonia
1%
Pseudomonal Sepsis
1%
Post Procedural Haemorrhage
1%
Procedural Pain
1%
Biliary Anastomosis Complication
1%
Complications of Transplanted Kidney
1%
Bile Duct Obstruction
1%
Bile Duct Stenosis
1%
Biliary Tract Disorder
1%
Autoimmune Hepatitis
1%
Cholestasis
1%
Lung Disorder
1%
Pulmonary Oedema
1%
Sinus Congestion
1%
Embolism Venous
1%
Orthostatic Hypotension
1%
Vasculitis
1%
Hyperglycaemia
1%
Graft Versus Host Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept + Sirolimus
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oral sirolimus tabletsExperimental Treatment1 Intervention
Sirolimus starting dose of 2 mg once daily, orally adjusted as need to maintain drug blood levels of 6-10 ng/ ml The first dose will be given at the week 12 visit and participants will be observed for 30 min
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,755 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,866 Total Patients Enrolled
Marie E Faughnan, MD MSc FRCPCPrincipal InvestigatorUnity Health Toronto
2 Previous Clinical Trials
35 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no known allergies or reactions to the study drug.I experience nosebleeds lasting over 15 minutes each week.I am a man and my partner can have children but we are not using effective birth control.I have received 2 doses of a COVID-19 vaccine.My immune system is weak.I am older than 18 years.I have been diagnosed with HHT either through clinical evaluation or genetic testing.You are allergic to the study drug or similar medications.I have had cancer before.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.Your creatinine levels are higher than the normal range.I currently have an infection.Your liver enzymes (AST or ALT) are more than twice the normal levels.You have high levels of cholesterol and triglycerides that have not been treated.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Oral sirolimus tablets
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it currently possible to sign up for this trial?
"The trial is still recruiting patients, if the information from clinicaltrials.gov is accurate. The study was originally posted on March 16th, 2022, and has been edited most recently on July 22nd, 2022."
Answered by AI
How many people are enrolled in this program?
"The information available on clinicaltrials.gov indicates that this study is still recruiting patients. The trial was originally posted on March 16th, 2022 and was last updated on July 22nd, 2022. 1 location is currently enrolling 10 participants."
Answered by AI
What is the FDA's official opinion on Sirolimus?
"Sirolimus has been evaluated in Phase 2 clinical trials, meaning that while there is some evidence for its safety profile, there is currently no data to suggest that it is an effective medication."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger