Health TrialsbyHealthPanel

TEPH: Telaglenastat Efficacy in Pulmonary Hypertension

ConditionPulmonary Hypertension
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChan, Stephen, MD, PhD

About this trial

The research study is being conducted to evaluate the effectiveness of a drug called Telaglenastat in adults diagnosed with Pulmonary Hypertension (PH). PH is a progressive condition that affects the arteries in the lungs, specifically the pulmonary arteries, which carry blood from the right side of the heart to the lungs. Telaglenastat is not currently approved by the Food and Drug Administration for the treatment of PH. However, the study investigators believe that Telaglenastat may help lower blood pressure in the lungs and improve both heart and lung function. It is important to note that the drug will not be available to participants once the study concludes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female age 18- 75 years old.

Able to provide written informed consent.

Able to comply with study procedures, able to undergo cardiac catheterization and exercise testing.

For Group 1and 3 PH, prior right heart catheterization (RHC) should show documented diagnosis of precapillary PH at mean pulmonary arterial pressure (mPAP > 20 mm Hg, PCWP<15 mm Hg, and PVR>3.5 WU) at screening..

Disqualifiers

Group 3 PH-ILD, patients receiving approved therapies other than inhaled Treprostinil, tadalafil or sildenafil for PAH less than 30 days before randomization are not eligible for enrollment.

Group 1 PH, patients naïve to medical treatment for PH are not eligible for enrollment.

History of lung reduction surgery or likely to undergo lung transplantation within the next 6 months.

Enrolled in, or planned participation in, device or other interventional clinical studies or cardio-pulmonary rehabilitation programs, based upon exercise within 90 days of Screening or during study participation.

Trial design

Design model

Single group

Treatments tested in this trial

  • Telaglenastat

    Drug

    The participant will need to come in for a screening visit prior prescribing the medication to confirm eligibility. The visit will include physical exams, labs, right heart cath, and maybe pulmonary function test and chest imaging. Eligible participants will be taking 800 mg Telaglenastat (CB-839) by mouth with food twice a day for a total of 12 weeks. Participants will need to come in for study related visits during this time. At the end of 12 months period, we will need to repeat same activities we did prior to prescribing to medication. Pending FDA approval, eligible participants may continue Telaglenastat for an additional 12 weeks.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Open-Label Telaglenastat ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pulmonary Vascular Resistance (PVR) measured via Right Hearth Catheterization (RHC)

We will use PVR to measure the effect of treatment on PH

Time frame
Visit 2 at week 1 and Visit 7 at week 12

Secondary outcomes

1

Functional class (FC)

We will use the functional class evaluated by licensed physician based on clinical history. Functional Class I: No symptoms with normal activity. Class II: Mild symptoms with ordinary activity (e.g., walking, climbing stairs). Class III: Noticeable symptoms with less-than-ordinary activity; limited daily tasks. Class IV: Symptoms at rest; unable to perform any physical activity without discomfort.

Time frame
The functional class will be determined at week 1 and 12
2

6 minute walk test

The person walks back and forth along a marked corridor for 6 minutes. They can slow down, stop, or rest if needed. The total distance walked is recorded in meters. Will be completed by clinical research coordinator

Time frame
6MWT will be at week 1 and 12
3

NT-proBNP

Blood work including NT-proBNP will be drawn by CRC

Time frame
Will be measure at week 1 and 12
4

Glutamine and glutamate plasma levels

Measure serum glutamine/glutamate ratio

Time frame
Will be done on screening visit, on week 1 and week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chan, Stephen, MD, PhD

Lead sponsor

University of Pittsburgh

Sponsor institution

Synhale Theraputics

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: