NCT02939599

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_2

Geographic Reach
3 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 28, 2020

Completed
Last Updated

January 5, 2021

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

October 12, 2016

Results QC Date

November 1, 2019

Last Update Submit

December 9, 2020

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary hypertension (PH),Increase blood pressure in the pulmonary arteryIncreased blood pressure in the pulmonary veinIncreased blood pressure in the lung vasculatureShortness of breathDizzinessFaintingLeg swellingCoughAngina pector

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) in Patients With PAH Over a Two Year Period

    Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported

    Two years

Secondary Outcomes (8)

  • Maximum Observed Plasma Concentration (Cmax)

    16 weeks

  • Time to Reach the Maximum Plasma Concentration (Tmax)

    16 Weeks

  • Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)

    16 weeks

  • Area Under the Plasma Concentration Time Curve From 0 to the End of a Dosing Interval (AUCtau)

    16 Weeks

  • Change From Baseline in Six Minute Walk Distance (6MWD)

    16 weeks

  • +3 more secondary outcomes

Study Arms (1)

QCC374

EXPERIMENTAL

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

Interventions

QCC374DRUG

0.015mg and 0.06mg

QCC374

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15261, United States

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, PulmonaryDyspneaDizzinessSyncopeCough

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersNeurologic ManifestationsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNervous System Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
8627788300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 20, 2016

Study Start

February 1, 2018

Primary Completion

November 6, 2018

Study Completion

November 6, 2018

Last Updated

January 5, 2021

Results First Posted

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Locations

US(1)DE(2)GB(1)