- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117791
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH ) (JPMS-CTEPH)
April 9, 2024 updated by: Bayer
Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment.
It is planned to include a total of 400 patients (valid for safety analysis).
This study is performed as an all-case investigation.
The treatment of Riociguat is performed based on the product label in Japan.
The standard observation period is 12 months from the 1st treatment of Riociguat.
Safety and effectiveness are evaluated at 4th and 12th month.
In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues.
When the treatment of Riociguat is terminated, observation of a patient ends.
For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system.
The duration of the study is approximately 9 years from launch.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1298
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Multiple Locations, Japan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Study population includes patients treated with Riociguat for inoperable CTEPH/ persistent or recurrent CTEPH after surgical treatment.
This study is performed as an all-case investigation.
Therefore, all patients who have been treated with Riociguat for CTEPH need to be registered in principle, until the target number of patients reached.
Description
Inclusion Criteria:
- Patients who are treated with Riociguat for CTEPH
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Riociguat treatment group
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The treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with treatment emergent adverse events and adverse drug reactions
Time Frame: up to 8 years
|
up to 8 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months
Time Frame: baseline and 4 months, and 12 months
|
baseline and 4 months, and 12 months
|
|
Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months
Time Frame: baseline and 4 months, and 12 months
|
baseline and 4 months, and 12 months
|
|
Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months
Time Frame: baseline and 4 months, and 12 months
|
baseline and 4 months, and 12 months
|
|
Change from baseline in BNP/NT-pro BNP after 4 and 12 months
Time Frame: baseline and 4 months, and 12 months
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baseline and 4 months, and 12 months
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Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months
Time Frame: baseline and 4 months, and 12 months
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baseline and 4 months, and 12 months
|
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Time to Clinical Worsening
Time Frame: up to 8 years
|
The first occurrence of the following events is recorded and will be considered for the calculation of the combined endpoint: • Death (all-cause mortality) • Heart/lung transplantation • Rescue Pulmonary Endarterectomy, Rescue Balloon Pulmonary Angioplasty or Hospitalization due to persistent worsening of Pulmonary Hypertension • Start of new PH specific treatment due to worsening Pulmonary Hypertension.
• Persistent decrease in 6MWD due to worsening pulmonary hypertension • Persistent worsening of functional class due to deterioration of Pulmonary Hypertension.
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up to 8 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bayer Study Director, Bayer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2014
Primary Completion (Actual)
April 3, 2023
Study Completion (Actual)
September 20, 2023
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 16, 2014
First Posted (Estimated)
April 21, 2014
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16843
- ADEMPAS-CTEPH (Other Identifier: company internal)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing".
This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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