|
Main
|
|
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. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
25 November 2019 |
|
Main ID: |
EUCTR2006-000252-41-GB |
|
Date of registration:
|
11/04/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
|
|
Scientific title:
|
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis |
|
Date of first enrolment:
|
29/06/2006 |
|
Target sample size:
|
325 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000252-41 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: yes
Other trial design description: 3 Arm
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
Italy
|
United Kingdom
| | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Clinical symptoms consistent with IPF, including the insidious onset of otherwise unexplained dyspnea on exertion, of =3 months duration
2. Diagnosis of IPF, defined as first instance in which a patient was informed of having IPF, within 48 months of randomization
3. Age 40 through 80 years, inclusive
4. High-resolution computed tomographic (HRCT) scan showing a pattern of disease consistent with a confident (definite) radiographic diagnosis of usual interstitial pneumonia (UIP)/IPF. For patients with surgical lung biopsy showing definite or probable UIP, the HRCT criterion of probable (UIP)/IPF is sufficient.
5. For patients aged <50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP within 48 months of randomization. In addition, there are no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage (BAL), if performed (see Table 3–1).
6. For patients aged more/equal to 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months of randomization (see Table 3–1):
a. Open or VATS lung biopsy showing definite or probable UIP (see Appendix C of protocol)
b. Transbronchial biopsy showing no features to support an alternative diagnosis. These alternative diagnoses include but are not limited to granulomatous disease, sarcoidosis, and hypersensitivity pneumonitis.
c. BAL showing no features to support an alternative diagnosis
Summary of Select Criteria for Diagnosis of IPF
Patient age =50 Years <50 Years
HRCT findings Definitive IPF Probable IPF Definitive IPF Probable IPF
Pathologic Nondiagnostic Surgical* lung Surgical* lung Surgical* lung
findings transbronchial biopsy with biopsy with biopsy with
biopsy or BAL, UIP UIP UIP
or surgicala lung
biopsy with UIP
*VATS or open lung.
7. Percent predicted FVC =50% at the Screen Visit and Day 1 (before randomisation). The change in FVC (measured in liters) between the Screen Visit and Day 1 must be =10% relative difference
8. Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon monoxide transfer capacity (DLco) =35% of predicted value at the Screen Visit only
9. Either FVC or Hb-corrected DLco less/equivalent to 90% of predicted value at the Screen Visit
10. No evidence of improvement in measures of IPF disease severity over the preceding year
11. Distance walked =150 meters (492 feet) with O2 saturation =83% on less/equal to 6 L/min of O2 during the 6-Minute Walk Test (6MWT) oxygen titration procedure performed during screening (see Study Reference Guide).
12. Able to understand and sign a written informed consent form
13. Able to understand the importance of adherence to study treatment and the study protocol, including the concomitant medication restrictions th
Exclusion criteria:
1.Not a suitable candidate for enrolment or unlikely to comply with the requirements of this study
2.Premature withdrawal from a randomized IPF clinical trial in the previous 2 years for any reason other than Sponsor decision or current participation in a clinical drug trial
3.FEV in the first second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at the Screen Visit and Day 1 before randomisation
4.Bronchodilator Response defined by an absolute increase of =12% and an increase of 200 mL in the predicted FEV1 or FVC or both after bronchodilator use compared to the values seen before bronchodilator at the Screen Visit and Day 1 before randomisation
5 RV >120% of predicted (before administration of bronchodilator)
6.History of clinically significant environmental exposure known to cause PF (including drugs, asbestos, beryllium, radiation, domestic birds)
7.Known explanation for interstitial lung disease
8.Diagnosis of any connective tissue disease including scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
9.Clinical evidence of active infection, including bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
10.In the clinical opinion of the investigator, the patient is expected to need and be eligible for a lung transplant within 72 weeks after randomisation.
11.Unable to undergo pulmonary function testing, which includes meeting the following reproducibility standards: At Screening, the 2 highest acceptable FVC values must be within 0.10 liter; At Day 1 the 2 highest acceptable FVC values must be within 0.10 liter; At Screening 2 of the 3 acceptable DLco values must be within 2 units (for TLco, within 0.67 SI units) of each other.
12.Any history of malignancy likely to result in death or significant disability or likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma)
13.Any condition other than IPF which, in the opinion of the investigator, is likely to result in the death of the patient within the next 2 years
14.History of advanced cirrhosis or clinically significant liver disease
15.History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months, including: Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty; Congestive heart failure requiring hospitalization; Uncontrolled arrhythmias; Asthma or chronic bronchitis requiring hospitalization in the last 6 months
16.Any condition, which, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone
17.Poorly controlled diabetes (defined by glycosylated hemoglobin [HbA1C] >10)
18.Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced then one o
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1
Level: LLT
Classification code 10021240
Term: Idiopathic pulmonary fibrosis
|
|
Intervention(s)
|
Product Name: Pirfenidone
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pirfenidone
CAS Number: 5317-13-8
Current Sponsor code: PIR, S-7701
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 133-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Pirfenidone
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pirfenidone
CAS Number: 5317-13-8
Current Sponsor code: PIR, S-7701
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 267-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
Main Objective: •To assess the efficacy of treatment with pirfenidone 2403 mg/d compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)
•To assess the safety of treatment with pirfenidone (1197 and 2403 mg/d) compared with placebo in patients with IPF
•To characterize the pharmacokinetic disposition of pirfenidone in patients with IPF
|
|
Secondary Objective:
|
|
Primary end point(s): The absolute change in percent predicted FVC from Baseline to Week 72.
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|