A Study of the Experimental Medicine Alvelestat (MPH966) for Chronic Obstructive Pulmonary Disease (COPD)

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 to 75 years old
Gender:
Any
Healthy Volunteers: No
Keywords: antitrypsin deficiency, COPD, Chronic Obstructive Pulmonary Disease
Type: Drug study, Phase 2
Target:
5 Participants
Investigator:
Description
Alpha-1 antitrypsin (α1AT) is a protein. It is made in the liver, circulates in the bloodstream, and protects lung tissue from an enzyme called elastase. Elastase is released by your white blood cells (a type of cell in your blood that helps fight infections). Elastase fights infection in the lungs, but can attack healthy lung tissue if not controlled by α1AT.

This study is being done to see if the study drug, alvelestat (MPH966), can inhibit the activity of elastase. Alvelestat is an experimental drug which has not been approved by the FDA.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Patients with a confirmed diagnosis of alpha-1-anti-trypsin deficiency and a PiZZ or null geno/phenotype and serum anti-alpha1 antitrypsin levels of less than 11uM
  • FEV1 ≥25% predicted
  • Computerised tomography (CT) scan evidence of emphysema
  • Non-smokers

Exclusion criteria:

  • Primary diagnosis of bronchiectasis
  • An ongoing acute exacerbation of the underlying lung disease
  • Underlying liver disease or abnormal liver function tests
  • Previous augmentation therapy within 6 months of dosing
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
We will pay you for each study visit completed at the research site according to the following schedule: Screening $75.00. Baseline $112.50. Week 1 $75.00. Week 2 $75.00. Week 3 (Telephone) $37.50. Week 4 $75.00. Week 6 $75.00. Week 8 $112.50. Week 10 (Telephone) $37.50. Week 12/EOT $112.50. Week 16 (Safety Follow-up) $75.00.

If you complete all the study visits, you will receive up to $862.50 for being in this study. If you choose to leave or we take you off the study for any reason, you will only receive payment for the visits that you have completed.
Resources
Schedule
Study duration and period
If you agree to take part in this study, you will receive study drug for about 12 weeks and you will be in this study for about 20 weeks in total. You will need to visit the research site about 9 times and receive 2 formal phone calls during the study.
Recruitment period
From April 3, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Alpha 1-Antitrypsin Deficiency
  • Emphysema
  • COPD