Trial record 7 of 31 for:    "hereditary hemorrhagic telangiectasia"

Submucosal Bevacizumab for the Management of Recurrent Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01402531
First received: July 19, 2011
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

This is a research study to find out more about the use of Avastin (proper chemical name is bevacizumab) in the treatment of epistaxis (nose bleeding) in patients with Hereditary Hemorrhagic Telangiectasia (HHT).


Condition Intervention Phase
Hereditary Hemorrhagic Telangiectasia (HHT)
Drug: Submucosal Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Submucosal Bevacizumab for the Management of Recurrent Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Epistaxis using the Epistaxis Severity Score, hematocrit, hemoglobin and serum feritin levels.. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Submucosal Bevacizumab
200mg Bevacizumab, submucosal injection
Drug: Submucosal Bevacizumab
200 mg Bevacizumab, injected submucosally- 100 mg per nostril
Other Name: Avastin

Detailed Description:

The treatment, regardless of participation in the proposed research, is to bring the patients to the operating room where under general anesthesia the nose is suctioned clean of blood clot, crust and secretion. The mucosa is then injected with a local anesthetic with adrenaline to reduce discomfort and to reduce bleeding. The nasal mucosa is treated with a KTP laser in our standard fashion. A 100mg of Avastin delivered in 4cc is then diluted with 4cc of normal saline to a total volume of 8cc. The dilution is made not for any known difference in treatment but rather it normally takes a minimum of 8cc to properly inject the nasal mucosa. The 1% Bevacizumab is then injected submucosally throughout the nasal cavity sparing the mucosa of the cartilage and the septum. The nasal cavity is then sprayed with 2cc of a fibrin sealant (EVICEL) this reduces postoperative bleeding and facilitates healing from the laser therapy. It has nothing to do with the Bevacizumab injection. The patient is then awakened and returned to the recovery room and discharged home. Beginning in approximately one week the patient is instructed to begin their hypertonic pulsatile nasal irrigations. They will follow-up in the clinic at 1 month. The data collection form is attached. Prior to treatment patient completes the HHT epistaxis severity score, blood is drawn for hematocrit, hemoglobin and serum feritin levels. Women of childbearing age all have a urine pregnancy test, required both by anesthesia and for the Bevacizumab study as well. Patients are followed monthly for the first 6 months. At 3 and 6 months the blood tests are repeated. For those living in San Diego they can be performed at UCSD. For those living outside the San Diego area they can be repeated by their primary care physician. For the ensuing 18 months patients are followed monthly either electronically or by telephone. ESS scores are calculated. Laboratory tests are not repeated. Patients are followed-up until such time as they begin re-bleeding and their ESS scores increase either above 2 or by 1 point above their 1 month post-op evaluation. Experience to date with 20 or 30 patients is that bleeding ceases within 1 to 2 weeks. Hence the 1 month score should be their optimum result. Adverse events will be recorded and appropriately reported to the IRB.

A new epistaxis severity score (ESS) has been developed and tested by the HHT Foundation. We have used this for the past several months and found it to be an excellent measure of HHT epistaxis. A copy is attached.

The minimum sample size is 10 patients. Study duration is planned for 24 months and if more patients are recruited they will be included. If fewer patients are recruited the study may be extended. Data will be reported by means and standard deviations. Patients will be compared individually and collectively to their pretreatment data specifically hematocrit, hemoglobin, serum ferritin and epistaxis severity score.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over the age of 18, both male and non-pregnant females capable of making informed consent who have HHT by Curacao criteria and whose nasal bleeding due to HHT is of such a magnitude that it requires medical care.
  • Females of childbearing age will be given a pregnancy test as a preliminary measure to ensure that those who become involved are not at risk.
  • Generally these patients will have an ESS score of 5 or greater. However on occasion an individual with a score between 2 and 5 but not capable of cleansing their nose adequately to be involved in a Bevacizumab spray treatment may be included.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402531

Contacts
Contact: Terence Davidson, M.D. 619-543-7466 tdavidson@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Terence Davidson, M.D.    619-543-7466    tdavidson@ucsd.edu   
Principal Investigator: Terence Davidson, M.D.         
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Terence Davidson, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT01402531     History of Changes
Other Study ID Numbers: 100295
Study First Received: July 19, 2011
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Hereditary hemorrhagic telangiectasia (HHT)
nosebleed
Bevacizumab
Avastin

Additional relevant MeSH terms:
Epistaxis
Telangiectasia, Hereditary Hemorrhagic
Telangiectasis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014