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Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients

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ClinicalTrials.gov Identifier: NCT02939599
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH. This study provides the patients who completed the QCC374X2201 study with the option to continue receiving QCC374. The study will monitor the long-term safety, tolerability and efficacy of QCC374 in patients with PAH.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: QCC374 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : November 6, 2018
Actual Study Completion Date : November 6, 2018


Arm Intervention/treatment
Experimental: QCC374

placebo patients from QCC374X2201 rolled into extension study will start at 0.03mg b.i.d. or 0.06mg b.i.d. and have the opportunity to up-titrate 0.12mg

-active patients will continue at the dose they finished on the QCC374X2201 study

Drug: QCC374
0.015mg and 0.06mg




Primary Outcome Measures :
  1. Number of AE and SAE in patients with PAH over a two year period [ Time Frame: Two years ]
    Adverse Events, Serious Adverse Events and all safety Assessments


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 16 weeks ]
    Cmax is the observed maximum plasma concentration following drug administration

  2. Tmax [ Time Frame: 16 Weeks ]
    Tmax is the time to reach the maximum concentration after drug administration

  3. AUClast [ Time Frame: 16 weeks ]
    AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

  4. AUCtau [ Time Frame: 16 Weeks ]
    The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau [mass x time / volume]

  5. Change from Baseline in Six Minute Walk Test (6MWT) [ Time Frame: Two Years ]
    Six Minute Walk Distance (6MWD)

  6. Change from Baseline in Echocardiography Measurements [ Time Frame: Two Years ]
    Key right ventricular (RV) function endpoints with echocardiography will include but not limited to tricuspid annular peak systolic velocity (TA S'), RV Tei index and RV fractional area change.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Subject was enrolled in the QCC374X2201 study and completed per protocol

Exclusion Criteria:

  • Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e. selexipag) since the last study drug intake in the QCC374X2201 study.
  • Females who are pregnant, or who plan to become pregnant during the study, or who are breastfeeding
  • Any known factor or disease that may interfere with treatment compliance or study conduct (i.e. drug or alcohol dependence)
  • Subjects who withdrew consent from the study QCC374X2201

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939599


Locations
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United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15261
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Heidelberg, Germany, 69120
United Kingdom
Novartis Investigative Site
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02939599     History of Changes
Other Study ID Numbers: CQCC374X2201E1
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pulmonary hypertension (PH),
Increase blood pressure in the pulmonary artery
Increased blood pressure in the pulmonary vein
Increased blood pressure in the lung vasculature
Shortness of breath
Dizziness
Fainting
Leg swelling
Cough
Angina pector

Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases