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All-Case Surveillance of Ofev in Patients With IPF in Japan
trial testing Nintedanib in Idiopathic Pulmonary Fibrosis in 10,117 participants. Completed in 2 May 2023.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10,117 |
| Start date | 31 August 2015 |
| Primary completion | 2 May 2023 |
| Estimated completion | 2 May 2023 |
| Sites | 1 location across Japan |
Boehringer Ingelheim — full company profile →
Eligibility, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients with any suspected Adverse Drug Reactions (ADRs) is presented.
| Group | Value | 95% CI |
|---|---|---|
| IPF Patients Receiving Nintedanib | 3852 |
Absolute change from baseline in Forced Vital Capacity (FVC) at Week 104 is presented. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured in Milliliter by spirometry.
| Group | Value | 95% CI |
|---|---|---|
| IPF Patients Receiving Nintedanib | -152.5 | ± 323.0 |
Time frame: Up to week 104. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | IPF Patients Receiving Nin… |
|---|---|---|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia bacterial | Infections and infestations | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Pneumonia aspiration | Infections and infestations | — |
| Cardiac failure | Cardiac disorders | — |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Death | General disorders | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | — |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | — |
| Liver disorder | Hepatobiliary disorders | — |
| Respiratory tract infection | Infections and infestations | — |
| Drug-induced liver injury | Hepatobiliary disorders | — |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Influenza | Infections and infestations | — |
| Cerebral infarction | Nervous system disorders | — |
| Cardio-respiratory arrest | Cardiac disorders | — |
| Pyrexia | General disorders | — |
| Reaction | System | IPF Patients Receiving Nin… |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — |
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Liver disorder | Hepatobiliary disorders | — |
| Nausea | Gastrointestinal disorders | — |
Most-reported serious reactions: Idiopathic pulmonary fibrosis, Pneumonia, Pneumothorax, Pneumonia bacterial, Respiratory failure, Malignant neoplasm progression, Dyspnoea, Decreased appetite.
Data from ClinicalTrials.gov NCT02607722 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing