All-Case Surveillance of Ofev in Patients With IPF in Japan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02607722|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : February 15, 2019
This is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the Ofev® Capsules treatment.
The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be followed up until discontinuation of Ofev® Capsules treatment.
As this is an observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for IPF must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed).
All patients administrated Ofev® Capsules after the launch at the sites contracted with the sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected. However the patient registration continues until the approval condition has been removed.
Patients participating in the subsequent follow-up will undergo regular observations. These observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment. Patients will not be followed any longer once they are reported to have discontinued the Ofev® Capsules treatment.
|Condition or disease||Intervention/treatment|
|Idiopathic Pulmonary Fibrosis||Drug: Nintedanib|
|Study Type :||Observational|
|Actual Enrollment :||5618 participants|
|Official Title:||The Special Drug Use-results Survey (All-Case Surveillance) of Ofev® Capsules in Patients With Idiopathic Pulmonary Fibrosis (IPF) in Japan|
|Actual Study Start Date :||August 31, 2015|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
Patients with IPF
- The primary endpoint of this study is the frequency of patients with any suspected Adverse Drug Reactions (ADRs) [ Time Frame: Week 104 ]
- The secondary endpoint of this study is absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 104 [ Time Frame: Week 104 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607722
|Multiple Locations, Japan|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|