Extension Study for LIQ861 Trials to Test the Long-term Safety of Dry Powder Inhalation of Experimental Treprostinil
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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 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Pulmonary Arterial Hypertension, PAH
Type: Drug study, Phase 3
Target:
5 Participants
Investigator:
Description
This extension study will test an experimental form of a drug called treprostinil. We will test the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH). “Experimental” means that dry powder treprostinil has not been approved by the FDA. Treprostinil has been approved by the FDA in other forms. It is available by prescription under the following brand names:

· Tyvaso® (treprostinil) inhalation solution
· Orenitram® (treprostinil) extended-release tablets
· Remodulin® (treprostinil) injection

The investigational form in this study is called LIQ861. It delivers the drug to your lungs in a different way than the currently marketed product. In this study, LIQ861 will be inhaled using a hand-held device called a dry powder inhaler (DPI).
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:

  1. Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
  2. Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861.
  4. Patient has completed the protocol defined end of study procedures or met a protocol-defined and adjudicated endpoint in the original LIQ861 study in which they were enrolled.
  5. Patient, whether male or female, agrees to use a medically acceptable method of contraception throughout the entire study period from informed consent through the termination visit, if the possibility of conception exists. Eligible male and female patients must also agree not to participate in a conception process (e.g., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of LIQ861.

Exclusion criteria:

  1. Patient prematurely discontinued LIQ861 due to a drug-related AE/SAE or tolerability issue in the original LIQ861 study in which they were enrolled, or patient did not complete protocol defined study procedures at an end of study visit (not Early Termination visit) in their original LIQ861 study.
  2. Patient withdrew consent during participation in another LIQ861 study.
  3. Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit).
  4. Patient has undergone lung or heart/lung transplant or the initiation of parenteral (intravenous [IV] infusion or subcutaneous injection) therapy with a prostacyclin during the time since participation in their original LIQ861 study.
  5. Any reason exists that, in the opinion of the Investigator or Medical Monitor, precludes the patient from participating in the study, e.g., any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
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 $100 for each in-person study visit you attend. Payment will be provided quarterly in the form of a check.
Resources
Schedule
Study duration and period
Your participation in this research will involve visits scheduled every 4 months for at least one year. Visits will occur every 6 months after that until the study drug is approved by the FDA or until the study is cancelled.
Recruitment period
From June 10, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Nikhil Jaha
Research Topic
Conditions:
  • Primary Pulmonary Hypertension

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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