Actively Recruiting
Anlotinib Capsules in the Treatment for IPF/PF-ILDs
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2026-02-17
30
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
C
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with FVC as the primary efficacy endpoint to evaluate its effectivenes
CONDITIONS
Official Title
Anlotinib Capsules in the Treatment for IPF/PF-ILDs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 40 to 85 years with any gender
- Voluntarily joined the study and signed informed consent with good compliance
- Diagnosed with IPF confirmed by HRCT within 5 years or PF-ILDs with specific fibrotic lung disease features
- HRCT showing 10% to less than 50% parenchymal fibrotic changes and less than 25% honeycombing for IPF
- For PF-ILDs, must meet criteria including decline in FVC or worsening respiratory symptoms with fibrosis increase
- Carbon monoxide diffusion capacity (DLco) between 30% and 80% of predicted value
- Forced vital capacity (FVC) at least 45% predicted
- Six-minute walk test distance at least 150 meters
- Arterial oxygen pressure (PaO2) at least 60 mmHg at rest and breathing room air
- Good major organ function meeting blood, biochemical, coagulation, thyroid, and echocardiography criteria
- Female participants of childbearing potential must use contraception and have a negative pregnancy test; male participants must use contraception
You will not qualify if you...
- Acute exacerbation of PF/PF-ILDs
- Conditions affecting oral medication intake such as dysphagia, chronic diarrhea, or intestinal obstruction
- Major surgery, incisional biopsy, or significant trauma within 28 days before study treatment
- Long-standing non-healing wounds or fractures
- Thrombotic events (e.g., stroke, deep vein thrombosis, pulmonary embolism) within past 6 months or bleeding disorders
- Severe or uncontrolled comorbidities including uncontrolled blood pressure, heart conditions, recent infections, severe pulmonary hypertension, renal failure requiring dialysis
- Immune deficiency diseases or history of organ transplantation
- Clinically significant liver disease or active viral hepatitis infection
- Poorly controlled blood glucose (FBG >10 mmol/L)
- Significant proteinuria (urine protein 2+ or >1.0g/24h)
- High-dose steroids or immunosuppressants use within 1 month before randomization
- Recent use of drugs that cause pulmonary fibrosis or anti-fibrotic drugs within 1 month
- Treatment with nintedanib or pirfenidone for less than 28 days before randomization
- Participation in other drug trials within 3 months before randomization
- Considered ineligible by the researcher
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
D
Dan Yao, Master
CONTACT
X
Xiaoying Huang, Docter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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