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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-11-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

QCC374

Intervention Type DRUG

0.015mg and 0.06mg

Interventions

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QCC374

0.015mg and 0.06mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No