CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Nintedanib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Documented diagnosis of IPF based on ATS/ERS/JRS/ALAT 2011 guidelines
  • ✓Nintedanib-naive or pirfenidone-pretreated patients
  • ✓Initiated or will initiate nintedanib per package insert after commercial availability in India (January 23, 2017)
  • ✓Voluntary informed consent obtainable from patient or legally authorized representative
Key exclusion· 3
  • ✕Prior nintedanib treatment
  • ✕Concurrent nintedanib and pirfenidone initiation
  • ✕Active participation in a clinical trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03047031
NCT03047031N/ACompleted
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An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim·observational·Posted Feb 8, 2017·Updated May 16, 2025

In Brief

An observational study evaluating Nintedanib and Pirfenidone for Idiopathic Pulmonary Fibrosis. Completed, enrolled 21 participants across 8 sites.

Detailed Summary

This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in clinical trials.This active surveillance aims to collect the safety data of 200 IPF patients treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017). The objective is to look at safety of nintedanib in the real world setting.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 8, 2017
Enrollment StartApr 5, 2017
Primary CompletionJul 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.4 years ago

Interventions

Nintedanibdrug

Nintedanib

Pirfenidonedrug

Pirfenidone