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Idiopathic Pulmonary FibrosisPhase 2NCT01504334

Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)

A Phase 2 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of lung disease characterized by fibrosis of the supporting framework (interstitium) of the lungs. By definition, the term is used only when the cause of the pulmonary fibrosis is unknown ("idiopathic"). Read more about this study

Who is it for?
Ages 18 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
80 participants
Where
1 siteChina
Study dates
Jan 2012to Mar 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent signed;
  • 18-75 years of age;
  • Clinically or multidisciplinarily 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;
  • Dyspnea symptoms relieved in the past 6 months;
  • Patients in acute exacerbation phase;
  • Diabetic patients whose fasting venous glucose >11.1 mmol/L;
  • Patients with malignant tumor and hemorrhagic diseases;
  • Patients with serious underlying pulmonary disease;
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  • 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);
  • Patients who has taken Acetylcysteine in the past 3 months;
  • Patients who has taken Prednisone>15mg/day(or other equivalent amount of glucocorticoid) and/or Immunosuppresants in the past 3 months;
  • Patients who has taken interferon, penicillamine, colchine or other agents for the treatment of IPF;
  • Pregnant or lactating women;
  • Participated in other clinical trials in the past 1 month;
  • The investigator assessed as inappropriate to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country.

Xu Zuojun, MD contact

+86-10-65295039

xuzj@hotmail.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijng, 100032

    Zuojun Xu, MD, 010-65295039, xuzj@hotmail.com

    Zuojun Xu, MD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for the Safety and Efficacy of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of lung disease characterized by fibrosis of the supporting framework (interstitium) of the lungs. By definition, the term is used only when the cause of the pulmonary fibrosis is unknown ("idiopathic"). Microscopically, lung tissue from patients shows a characteristic set of histologic/pathologic features known as usual interstitial pneumonia (UIP). UIP is therefore the pathologic counterpart of IPF.Idiopathic pulmonary fibrosis is characterized by radiographically evident interstitial infiltrates predominantly affecting the lung bases and by progressive dyspnea and worsening of pulmonary function. No therapy has been clearly shown to prolong survival. The current strict definition of idiopathic pulmonary fibrosis provides a new focus for basic and clinical research that will improve insight into the pathogenesis of this disorder and stimulate the development of novel therapies.

Pirfenidone has proven antifibrotic and anti-inflammatory properties in various in vitro systems and animal models of pulmonary fibrosis, although its precise mechanism of action remains unclear. It attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokines such as transforming growth factor-β. It is also shown to slow tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor and platelet-derived growth factor.

Pirfenidone has not been widely approved for clinical use in China, in this study, safety and efficacy were evaluated to see if pirfenidone has a significant advantage over placebo in terms of improving lung function and life quality etc. (see primary and secondary criteria) or slows down the deterioration of lung function in Chinese subjects diagnosed with IPF.

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 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week.

  • PlaceboDrug

    Placebo（without active ingredient） tablets will be taken 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week for both groups.

Study groups in NCT01504334
Study groupRoleWhat they receive
Pirfenidone(200mg)ExperimentalPirfenidone（200mg）tablets will be taken 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week.
Receives: Drug: Pirfenidone
Placebo (without active ingredient)Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in forced vital capacity (FVC)

    Changes in FVC from 48 weeks to baseline

    Measured: 48 weeks

Secondary outcomes (7)

  1. Changes in lung function (including arterial blood gas analysis)

    Lung function will be assessed as improved/stabilized/exacerbated from 48 weeks to baseline.

    Measured: 48 weeks

  2. Acute Exacerbation during the whole treatment procedure（frequency and severity）

    The following clinical deterioration symptoms within a month that cannot be explained by other reasons will be assessed as acute exacerbation:

    1. Aggravated dyspnea;
    2. Newly discovered chest interstitial lung abnormality by radiograph/HRCT, without pneumothorax or pleural effusion;
    3. PaO2 decreases ≥10mm Hg，heart failure or pulmonary embolism excluded.

    Acute Exacerbation can be assessed if 1 and 2 appear or 1 and 3 appear.

    Measured: 48 weeks

  3. Progression-free time

    Progression of disease during the whole study period is defined as follows:

    1. Progressive dyspnea (objective evaluation);
    2. FVC absolute value progressively and constantly decreases compared with baseline value;
    3. DLCO absolute value (after hemoglobin calibration) progressively and constantly decreases compared with baseline value;
    4. Fibrosis progressive deterioration by HRCT examination;
    5. Acute Exacerbation;
    6. Death caused by respiratory failure.

    Measured: 48 weeks

  4. 6 Minute Walk Test (6MWT )： Changes in 6 minute walk distance (6MWD) and SpO2 from 48 weeks to baseline

    Method: The walking test is conducted in a corridor 33 meters long. The patient is instructed to "walk from end to end, covering as much ground as they can in the allotted time". The total distance ambulated in meters during the 6-minute walk test and the number of rest stops is recorded. 6MWD, weight, heart rate, BP, SpO2, and a self-reported rating of perceived exertion [modified Borg RPE scale rating (0 to 10 scale)] is recorded after the walk.

    Measured: 48 weeks

  5. Borg RPE scale rating improvement rate during the whole study period

    Patient percentage whose Borg RPE scale rating improves more than 1 level.

    Measured: 48 weeks

  6. Lung interstitial change observed by HRCT

    Changes in HRCT lung interstitial evaluation score from 48 weeks to baseline

    Measured: 48 weeks

  7. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionNov 2012 (estimated)
  4. Study completionMar 2013 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504334
Sponsor's protocol ID
KAWIN-001
Status last verified
Feb 2012
First submitted
30 Dec 2011
Last updated
7 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Huang H, Dai HP, Kang J, Chen BY, Sun TY, Xu ZJ. Double-Blind Randomized Trial of Pirfenidone in Chinese Idiopathic Pulmonary Fibrosis Patients. Medicine (Baltimore). 2015 Oct;94(42):e1600. doi: 10.1097/MD.0000000000001600.

    PubMed 26496265

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 1 site in 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 13 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: status not confirmed, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xu Zuojun, MD (+86-10-65295039, xuzj@hotmail.com), or a site near the patient. 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?

On the ClinicalTrials.gov record for NCT01504334, which also lists 1 linked publication.

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 7 Feb 2012.

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