Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01469169
• Date of registration: 08/11/2011
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study IBUKI
• Scientific title: A Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH)
• Date of first enrolment: June 19, 2012
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01469169
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects aged 18 to 75 years

- Symptomatic Pulmonary Artery Hypertension (PAH) classified (Dana Point Classification
1)

- New York Heart Association (NYHA)/World Health Organization (WHO) functional class III
or IV

- PAPmean at rest > 25 mm Hg, Pulmonary capillary wedge pressure (PCWP) or left
ventricular end-diastolic pressure (PVR) >/= 240 dyn.sec.cm-5 (>/= 400 dyn.sec.cm-5 for patients treated with both
endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitor (PDE5i) ) as
measured by Right Heart Catheter test

- Women of childbearing potential and men must agree to use adequate contraception when
sexually active

Exclusion Criteria:

- Baseline 6-minute walk distance of less than 100 meters or more than 500 meters

- Subjects with critical severe PAH

- Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio < 60%
and/or Total Lung Capacity (TLC) < 70% predicted (especially at interstitial lung
disease, TLC < 60% predicted)

- Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive
pulmonary disease )

- More than mild patchy interstitial lung disease on High Resolution Computerized
Tomography (HRCT)

- History of left-sided heart disease

- Uncontrolled systemic hypertension as evidenced by systolic blood pressure >/= 160 mm
Hg or diastolic blood pressure >/= 100 mm Hg on repeated measurement

- Systemic hypotension with systolic blood pressure < 85 mm Hg



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: Iloprost (Ventavis inhaled, BAYQ6256)

Primary Outcome(s)

Area under the plasma concentration vs time curve from start of inhalation to infinity after single inhalation (AUC) [Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks]

Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation) [Time Frame: At baseline and 12 weeks]

Number of participants with adverse events as a measure of safety and tolerability [Time Frame: Over 52 weeks]

Maximum drug concentration in plasma after start of inhalation (Cmax) [Time Frame: Up to 12 weeks]

Number of participants with adverse events as a measure of safety and tolerability [Time Frame: Up to 52 weeks]

Secondary Outcome(s)

Change in 6-minute walking test (6MWT) [Time Frame: At baseline, 12 weeks and 52 weeks]

Change in Mean arterial pressure (MAP) [Time Frame: At baseline and 12 weeks]

Need for transplantation during the study [Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks]

Change in Mean right atrial pressure (RAPm) [Time Frame: At baseline and 12 weeks]

Change in Systemic vascular resistance (SVR) [Time Frame: At baseline and 12 weeks]

Maximum drug concentration in plasma after start of inhalation divided by dose (µg) (Cmax/D) [Time Frame: Up to 12 weeks]

Mortality during the study [Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks]

Quality of life assessed by EQ-5D and Living with Pulmonary Hypertension (LPH) questionnaires [Time Frame: At baseline, 12 weeks and 52 weeks]

AUC divided by dose (µg) (AUC/D) [Time Frame: Up to 12 weeks]

Change in Borg CR 10 Score [Time Frame: At baseline, 12 weeks and 52 weeks]

Change in Cardiac index [Time Frame: At baseline and 12 weeks]

Change of diastolic pulmonary artery pressure from baseline to week 12 [Time Frame: At baseline and 12 weeks]

Change of mean of pulmonary artery pressure from baseline to week 12 [Time Frame: At baseline and 12 weeks]

Half-life associated with the terminal slope (t1/2) [Time Frame: Up to 12 weeks]

AUC from time start of inhalation to the last data point AUC(0-tlast) [Time Frame: Up to 12 weeks]

Change in Cardiac output (CO) [Time Frame: At baseline and 12 weeks]

Change Mixed venous oxygen saturation (SVO2) [Time Frame: At baseline and 12 weeks]

Change in N-terminal pro-B-type natriuretic peptide (NT-ProBNP) [Time Frame: At baseline, 12 weeks and 52 weeks]

Time to clinical worsening during the study [Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks]

Change in New York Heart Association/ World Health Organization (NYHA/WHO) class [Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks]

Maximum drug concentration in plasma after start of inhalation divided by dose (µg) per kg body weight (Cmax,norm) [Time Frame: Up to 12 weeks]

AUC divided by dose per kg body weight (AUCnorm) [Time Frame: Up to 12 weeks]

Change in Pulmonary capillary wedge pressure (PCWP) [Time Frame: At baseline and 12 weeks]

Time to reach maximum drug concentration in plasma after start of inhalation (tmax ) [Time Frame: Up to 12 weeks]

Change of systolic pulmonary artery pressure from baseline to week 12 [Time Frame: At baseline and 12 weeks]

Change in Systemic vascular resistance index (SVRI) [Time Frame: At baseline and 12 weeks]

Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12 [Time Frame: At baseline and 12 weeks]

Secondary ID(s)

15503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors