Ignite Creation Date:
2024-05-05 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00781885
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2008-10-27
Brief Title:
A Multi-Center Open-Label Multiple Dose Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients
Sponsor:
Lung Biotechnology PBC
Organization:
Lung Biotechnology PBC
Study Overview
Official Title:
A Multi-Center Open-Label Multiple Dose Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an international open-label multi-center Phase II multiple dose dose-finding study to investigate the safety tolerability and pharmacokinetic characteristics of BPS-MR tablets in male and female patients with PAH
Patients who meet the inclusionexclusion criteria will enter the Treatment Phase at a Baseline visit Patients will begin taking one BPS-MR tablet 60µg twice daily bid escalating by one tablet bid each week to a maximum dose of 600µg ten tablets bid or until the patient reaches their MTD Following the achievement of the MTD patients will be down-titrated off BPS-MR in weekly one tablet bid decrements Patients may alternatively elect to continue taking the study drug at their MTD in a separate open-label extension study
Patients who meet the inclusionexclusion criteria will enter the Treatment Phase at a Baseline visit Patients will begin taking one BPS-MR tablet 60µg twice daily bid escalating by one tablet bid each week to a maximum dose of 600µg ten tablets bid or until the patient reaches their MTD Following the achievement of the MTD patients will be down-titrated off BPS-MR in weekly one tablet bid decrements Patients may alternatively elect to continue taking the study drug at their MTD in a separate open-label extension study
Detailed Description:
This study is an international open-label multi-center Phase II multiple dose dose-finding study to investigate the safety tolerability and pharmacokinetic characteristics of BPS-MR tablets in male and female patients with PAH All patients will be receiving background therapy with either a phosphodiesterase PDE-5 inhibitor endothelin receptor antagonist ERA or the combination of these two
The study is divided into two phases
1 The Treatment Phase and
2 The Down-Titration Phase
Screening will be conducted on an outpatient basis within 21 days prior to the Baseline visit Patients meeting the inclusionexclusion criteria at the Baseline visit will enter the Treatment Phase and begin taking one BPS-MR tablet 60µg bid and escalating by one tablet bid each week to a maximum dose of 600µg ten tablets bid or until the patient reaches an intolerable dose
Patients who reach an intolerable dose will be instructed to continue treatment at the previous dose which will be considered as their individual MTD For example if a patient attains a full week of six BPS-MR tablets bid 360µg but is unable to tolerate seven tablets 420µg then the patient will return to using six tablets of BPS-MR bid 360µg for up to an additional week of treatment In this scenario BPS-MR 360µg bid is the patients MTD Patients who do not reach an intolerable dose and tolerate the full ten weeks of BPS-MR dosing will be considered to have their individual MTD as BPS-MR 600µg bid
When patients reach their individual MTD either at 10 weeks or earlier they will return to the site 3-7 days after for an End of Treatment Phase assessment to be evaluated for safety and optionally a PK assessment Subsequent to the End of Treatment Phase visit patients will be instructed to begin down-titration off of BPS-MR in weekly increments However patients may alternatively elect to continue taking BPS-MR at their MTD in a separate open-label extension study
The study is divided into two phases
1 The Treatment Phase and
2 The Down-Titration Phase
Screening will be conducted on an outpatient basis within 21 days prior to the Baseline visit Patients meeting the inclusionexclusion criteria at the Baseline visit will enter the Treatment Phase and begin taking one BPS-MR tablet 60µg bid and escalating by one tablet bid each week to a maximum dose of 600µg ten tablets bid or until the patient reaches an intolerable dose
Patients who reach an intolerable dose will be instructed to continue treatment at the previous dose which will be considered as their individual MTD For example if a patient attains a full week of six BPS-MR tablets bid 360µg but is unable to tolerate seven tablets 420µg then the patient will return to using six tablets of BPS-MR bid 360µg for up to an additional week of treatment In this scenario BPS-MR 360µg bid is the patients MTD Patients who do not reach an intolerable dose and tolerate the full ten weeks of BPS-MR dosing will be considered to have their individual MTD as BPS-MR 600µg bid
When patients reach their individual MTD either at 10 weeks or earlier they will return to the site 3-7 days after for an End of Treatment Phase assessment to be evaluated for safety and optionally a PK assessment Subsequent to the End of Treatment Phase visit patients will be instructed to begin down-titration off of BPS-MR in weekly increments However patients may alternatively elect to continue taking BPS-MR at their MTD in a separate open-label extension study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None