Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)Phase 3NCT03856853
Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease
A Phase 3 study testing Pirfenidone in people with Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild), run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the eEfficacy and safety of pirfenidone in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)
- What is being tested?
- Pirfenidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2018to 10 May 2021
- Phase
- Phase 3
- 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
- 1.Female or male subjects aged between 18 and 75 years of age. 2.2013 ACR / EULAR classification criteria for SSc fulfilled. 3.SSc disease onset (defined by first non-Raynaud symptom) within 5 years. 4.SSc related Interstitial Lung Disease confirmed by HRCT. 5.Forced vital capacity (FVC) 40% to 70% predicted(include 40% and70% ). 6.Subject have the ability to understand and sign the informed consent before the trials.
Who cannot join
- Subjects not fulfill all of the above inclusion criteria.
- AST, ALT >1.5 x ULN.
- Bilirubin >1.5 x ULN.
- Creatinine clearance <30 mL/min.
- Airway obstruction (pre-bronchodilator FEV1/FVC <0.7).
- Other clinically significant pulmonary abnormalities.
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- Allergic to test drugs or components (e.g. lactose).
- Clinical Significant Pulmonary hypertension:.
- Significant past clinical evidence or echocardiography of right heart failure.
- History of right heart catheterization showed that cardiac index ≤ 2 l/min/m2.
- Pulmonary hypertension, which needs to use EPoprostenol/ Treprostinil for parenteral treatment .
- Cardiovascular diseases:
- Six weeks in severe hypertension, and out of control after treatment(≥160/100mmHg).
- Myocardial infarction within six months.
- A period of 6 months in unstable angina.
- More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers.
- Bleeding risk, including the following criterias:
- Predisposition to bleeding. b.Subjects need to the following treatments: i.Fibrinolysis, full-dose anticoagulation therapy(such as vitamin K antagonists, direct thrombin inhibitor, heparin, Hirudin ).
- High dose antiplatelet therapy[Note: not prohibited to maintain equipment needed indwelling venous pathway prophylactic low dose of heparin or heparin fluid (e.g. enoxaparin, daily 4000 I.U. s.c.) and the prevention of the use of antiplatelet therapy (e.g. acetylsalicylic acid, until 325 mg/d, or other antiplatelet dose of 75 mg/d the same dose of clopidogrel, or treatment)].
- c.history of hemorrhagic central nervous system (CNS) event within last year. d. Any of the following conditions within 3 months: i.Hemoptysis or hematuria ii. Active gastrointestinal bleeding or gastrointestinal ulcer. iii. major trauma or major surgery (researchers determined). e.coagulation parameters:international normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
- May interfere with detection procedures (such as interrupt oxygen intolerance in pulmonary function tests) or based on the researchers estimate, may affect the test to participate in or participate in the test may put patients at risk of disease or other complications (such as caused by SSc severe gastrointestinal symptoms).
- Researchers determined that life expectancy was due to other diseases (non SSc) for a period of up to 2.5 years.
- Clinical signs of malabsorption or needing parenteral nutrition.
- History of thrombotic event within last year(Including stroke and transient ischemic attack).
- Previous treatment with nintedanib or pirfenidone.
- Use the following medicine:
- Treatment with prednisone >10 mg/day within 2 weeks.
- Treatment with azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine within 8 weeks .
- Treatment with cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium para-aminobenzoate within 6 months.
- Unstable background therapy with cyclophosphamide or mycophenolate mofetil / sodium or methotrexate (not allow treatment). Patients must or A. patients cannot receive immunosuppressive therapy, sodium cyclophosphamide or mycophenolate mofetil / or MTX stable or B. within 6 months of acceptance, and in at least 6 months after randomization, the treatment to keep the background stable (exclusion criteria 16 and 17 and the combined use of early precautions).
- Previous or planned hematopoietic stem cell transplantation next year.
- Major surgery is planned during the treatment period.
- Pregnancy or lactation or make a schedule during the trials.
- Give the drug 28 days before or after administration of the 3 month period, women of childbearing age * are unwilling or unable to use contraceptive methods highly effective (according to ICH M3 (R2)), a highly effective means in the correct and consistent application of a barrier method when the failure rate of less than 1% per year. * women of childbearing age is defined has undergone menarche and in line with "infertile women" standard "[female infertile women" is defined as: postmenopausal period (12 months without menstruation, no other medical reasons) or permanent sterilization (e.g., tubal occlusion, hysterectomy, bilateral ovarian resection or bilateral tubal resection women)].
- (23)According to the researchers,exhibited evidence of alcohol or drug abuse. (24)Patients who were unable to understand or comply with the procedure were included in the self-administered questionnaire, which was completed without help.
- 25.Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment).
- 26.Clinical signs of malabsorption or needing parenteral nutrition. 27.With active peptic ulcer. 28.With mental illness . 29.Within 3 months to participate in other clinical trials. 30.Researchers determined that they did not participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhang, Ling
Beijing, Beijing Municipality, 100102
Ling Zhang, +86-13501209210, rlzhang1006@163.com
Qian Wang, +86-13681211155, zhengaqian@icloud.com
About this study
Official title: A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
The purpose of this study is to evaluate the eEfficacy and safety of pirfenidone in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
- Being tested
- Pirfenidone, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
pirfenidone for SSc-ILD treatment
placeboOther
as control
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | pirfenidone group Receives: Drug: Pirfenidone |
| placebo group | Placebo comparator | placebo group Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline (%) of FVC%
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start15 Jun 2018
- Primary completion10 Feb 2021 (estimated)
- Study completion10 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Genomics, Inc., GNI-EPS Pharmaceuticals, Inc. (GNI Group)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856853
- Sponsor's protocol ID
- GNI-F647-1701
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
- ClinicalTrials.gov ID
- NCT03856853
- Acronym / sponsor ID
- GNI-F647-1701
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Genomics, Inc., GNI-EPS Pharmaceuticals, Inc. (GNI Group)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 10 Feb 2021 (estimated)
- Study completion
- 10 May 2021 (estimated)
- First posted
- 27 Feb 2019 (actual)
- 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.
The purpose of this study is to evaluate the eEfficacy and safety of pirfenidone in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Pirfenidonepirfenidone group |
| placebo group | Placebo comparator | Other: placeboplacebo group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Female or male subjects aged between 18 and 75 years of age. 2.2013 ACR / EULAR classification criteria for SSc fulfilled. 3.SSc disease onset (defined by first non-Raynaud symptom) within 5 years. 4.SSc related Interstitial Lung Disease confirmed by HRCT. 5.Forced vital capacity (FVC) 40% to 70% predicted(include 40% and70% ). 6.Subject have the ability to understand and sign the informed consent before the trials.
Key exclusion criteria (37 listed)
- Subjects not fulfill all of the above inclusion criteria.
- AST, ALT >1.5 x ULN.
- Bilirubin >1.5 x ULN.
- Creatinine clearance <30 mL/min.
- Airway obstruction (pre-bronchodilator FEV1/FVC <0.7).
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 for SSc-ILD treatment | Drug | treatment group |
| placeboas control | Other | placebo group |
Primary outcome
Relative change from baseline (%) of FVC%
Time frame: 52 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pirfenidone in people with Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild), run by Beijing Continent Pharmaceutical 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 1 inclusion and 37 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 27 Feb 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change from baseline (%) of FVC% (time frame: 52 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 27 Feb 2019.