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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01417156 |
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Date of registration:
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15/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)
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Scientific title:
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A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01417156 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Written informed consent consistent with Good Clinical Practice (GCP) signed prior to
entry into the study
2. Completion of 1199.31 study and still under treatment with pirfenidone at a stable
dose
Exclusion criteria:
1. Any disease that may interfere with testing procedures or in judgement of investigator
may interfere with trial participation or may put the patient at risk when
participating in this trial. Reconsider carefully all exclusion criteria of trial
1199.31. However, patients may qualify for participation even though they meet the
exclusion criteria (for 1199.31), if the investigators benefit-risk assessment remains
favorable.
2. Any other investigational therapy received within 8 weeks before visit 1.
3. For female: Pregnant women or women who are breast feeding or of child bearing
potential not using a highly effective method of birth control for both at least 4
weeks prior to enrolment and 10 weeks after last study drug intake.
For male: Sexually active males not committing to using condoms both during the course
of the study and ten weeks after last study drug intake (except if their partner is
not of childbearing potential).
4. Known or suspected active alcohol or drug abuse.
5. Patients who require full-dose therapeutic anticoagulation (e.g. vitamin K
antagonists, heparin), except low dose heparin and/or heparin flash as needed for
maintenance of an indwelling intravenous device. As an example, prophylactic use of
heparin, e.g. enoxaparin 2000 International unit (I.U.) subcutaneously (s.c.) per day,
should be allowed.
6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel)
therapy. As an example, chronic low-dose acetyl salicylic acid, below or equal to 100
mg per day, should be allowed.
7. Patient not compliant in previous trial, with trial medication or trial visits.
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Fibrosis
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Intervention(s)
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Drug: Pirfenidoneone
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Drug: Nintedanib
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Primary Outcome(s)
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Incidence of Overall Adverse Events
[Time Frame: First drug administration until end of treatment, up to 5 years]
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Secondary Outcome(s)
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Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.
[Time Frame: Week 234]
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Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.
[Time Frame: First drug administration until end of treatment, up to 5 years]
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Annual Rate of Decline in Forced Vital Capacity (FVC).
[Time Frame: Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years]
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Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
[Time Frame: Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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