Idiopathic Pulmonary FibrosisPhase 2IPFNCT02136992
Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent signed;
- Age ≤75 years;
- Clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
- Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.
Who cannot join
- Allergic to pirfenidone;
- Patients with serious Significant pulmonary infection need anti-infection treatment;
- Patients who has taken interferon, penicillamine or other agents for the treatment of IPF;
- Patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month;
- Patients who has taken immunosuppressants in the past 1 month;
- Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
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- Patients with malignant tumor in the past 5 years;
- Participated in other clinical trials in the past 3 months;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times above the upper level of normal value range), kidney disease(Cr above the upper level of normal value range);
- Pregnant or lactating women;
- The investigator assessed as inappropriate to participate in this clinical trial.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases.
Read the detailed description
The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 12w, 24w, 36w, 48w.all participants will be required to check the various efficacy and safety indicators.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Pirfenidone, placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.
placeboDrug
placebo will be taken two tablets 3 times a day during the whole study process
| Study group | Role | What they receive |
|---|---|---|
| Placebo (without active ingredient) | Placebo comparator | placebo will be taken two tablets 3 times a day during the whole study process. Receives: Drug: Pirfenidone; Drug: placebo |
| Pirfenidone（200mg） | Experimental | Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process. Receives: Drug: Pirfenidone; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in forced vital capacity (FVC)
to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks
Measured: 48 weeks
Secondary outcomes (4)
changes in lung function (including Forced expiratory volume in one second (FEV1) and The differences of diffusing capacity of the lung for carbon monoxide (DLco) )
Lung function will be measured as improved/stabilized/exacerbated from baseline to 12 weeks/24 weeks/36 weeks/48 weeks
Measured: 48week
Changes in 6 minute walk distance (6MWD)
Changes in 6 minute walk distance (6MWD) and from baseline to 12/24/36/48weeks
Measured: 48 weeks
Life quality: assessed by St. George respiratory questionnaire (SGRQ).
Life quality will be assessed as improved if SGRQ single or total score increased >4% when completing the trial; Life quality will be assessed as stabilized if SGRQ single or total score changes within the range of 4% when completing the trial; Life quality will be assessed as exacerbated if SGRQ single or total score decreased >4% when completing the trial.
Measured: 48 weeks
Dyspnea score according by Modified Medical Research Center(MMRC)
to measure rating dyspnea according by Medi Medical Research Center(MMRC)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Chia-tai Tianqing Pharmaceutical
- Responsible party
- Principal investigator, Huiping Li, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Huiping Li, Principal investigator, Shanghai Pulmonary Hospital , Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136992
- Sponsor's protocol ID
- SPH01312
- Acronym
- IPF
- Status last verified
- May 2014
- First submitted
- 11 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02136992
- Acronym / sponsor ID
- IPF / SPH01312
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Nanjing Chia-tai Tianqing Pharmaceutical
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases.
Detailed description
The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 12w, 24w, 36w, 48w.all participants will be required to check the various efficacy and safety indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (without active ingredient) | Placebo comparator | Drug: Pirfenidone, Drug: placeboplacebo will be taken two tablets 3 times a day during the whole study process. |
| Pirfenidone（200mg） | Experimental | Drug: Pirfenidone, Drug: placeboPirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent signed;
- Age ≤75 years;
- Clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
- Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.
Key exclusion criteria (11 listed)
- Allergic to pirfenidone;
- Patients with serious Significant pulmonary infection need anti-infection treatment;
- Patients who has taken interferon, penicillamine or other agents for the treatment of IPF;
- Patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month;
- Patients who has taken immunosuppressants in the past 1 month;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirfenidonePirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process. | Drug | Pirfenidone（200mg）, Placebo (without active ingredient) |
| placeboplacebo will be taken two tablets 3 times a day during the whole study process | Drug | Pirfenidone（200mg）, Placebo (without active ingredient) |
Primary outcome
Changes in forced vital capacity (FVC)
Time frame: 48 weeks
to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks
4 secondary outcomes
changes in lung function (including Forced expiratory volume in one second (FEV1) and The differences of diffusing capacity of the lung for carbon monoxide (DLco) )
Time frame: 48week
Changes in 6 minute walk distance (6MWD)
Time frame: 48 weeks
Life quality: assessed by St. George respiratory questionnaire (SGRQ).
Time frame: 48 weeks
Dyspnea score according by Modified Medical Research Center(MMRC)
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiping Li principal investigator
Shanghai Pulmonary Hospital , Tongji University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Shanghai Pulmonary Hospital, Shanghai, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in forced vital capacity (FVC) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.