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A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902509
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Continent Pharmaceutical Co, Ltd.

Brief Summary:
Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

Condition or disease Intervention/treatment Phase
Radiation-induced Lung Injury Drug: Pirfenidone Drug: basic treatment Phase 2

Detailed Description:
The study is a randomized, controlled, multi-site clinical trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

Arm Intervention/treatment
Experimental: Pirfenidone
pirfenidone + basic treatment
Drug: Pirfenidone
pirfenidone capsule made in China

Drug: basic treatment
glucocorticoid and expectant treatment etc.

Controll
with basic treatment and without pirfenidone treatment
Drug: basic treatment
glucocorticoid and expectant treatment etc.




Primary Outcome Measures :
  1. DLco% change [ Time Frame: Week 8 and 24 ]
    Compare DLco% from basement to the end of treatment


Secondary Outcome Measures :
  1. The grade change of radiation-induced lung injury [ Time Frame: Week 8 and 24 ]
  2. The score change of CT [ Time Frame: Week 8 and 24 ]
  3. Increase of effective lung volume [ Time Frame: Week 8 and 24 ]
  4. The grade change of Cough, Dyspnea and Fever [ Time Frame: Week 8 and 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-75 years old (including 18 and 75 years);
  2. clinically diagnosed grade 2 or 3 radiation-induced lung injury;
  3. the course of radiation-induced lung injury is less than 2 months;
  4. ECOG 0-2;
  5. the expected survival time is more than 6 months;
  6. the functional level of major organs meets the following standards: ANC≥3.0×109/L,PLT≥100×109/L,Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN, ALT、AST≤2.0×ULN
  7. capable of eating solid food upon enrollment;
  8. subjects will voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

  1. have a history of chronic bronchial acute attack or severe pulmonary heart disease;
  2. pneumonectomy;
  3. tumor progression;
  4. severe pulmonary infection;
  5. creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;
  6. concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
  7. patients with active peptic ulcer;
  8. pregnant women and patients with mental illness;
  9. participating in clinical trials of other drugs within 3 months;
  10. the investigator determined that subject was not suitable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902509


Contacts
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Contact: Lvhua Wang +86 10-67781331 cancergcp@163.com
Contact: Ming Chen +86 0571-88122222 zjzliec@163.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Science Not yet recruiting
Beijing, Beijing, China, 100021
Contact: Lvhua Wang         
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Ming Chen         
Sponsors and Collaborators
Beijing Continent Pharmaceutical Co, Ltd.
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Responsible Party: Beijing Continent Pharmaceutical Co, Ltd.
ClinicalTrials.gov Identifier: NCT03902509    
Other Study ID Numbers: RP-F647-201901
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Continent Pharmaceutical Co, Ltd.:
pirfenidone
Additional relevant MeSH terms:
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Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents