Pulmonary Arterial Hypertension (PAH)ORIENTATIONNCT06968962
Comparison of Sequential to Initial Combination Therapy in PAH
A study testing Tadalafil, Ambrisentan and Ambrisentan mimic in people with Pulmonary Arterial Hypertension (PAH), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in patients with pulmonary arterial hypertension (PAH). Ambrisentan and Tadalafil will be used in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- Tadalafil, Ambrisentan and Ambrisentan mimic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 80 years and weight ≥ 40 kg.
- WHO functional classification I-III.
- Diagnosed with PAH caused or related to the following:
- 1) Idiopathic PAH 2) Hereditary PAH 3) Associated PAH:
- Connective tissue diseases (e.g., scleroderma, systemic lupus erythematosus, mixed connective tissue disease, etc.)
- Drug or toxin exposure
Show all 15Show fewer
- Corrected congenital heart diseases for more than 1 year (e.g., atrial septal defect, ventricular septal defect, and patent ductus arteriosus) 4. Risk stratification assessed as low-risk or intermediate-risk according to the 2022 ESC/ERS guidelines.
- 5. Right heart catheterization meets the following criteria (end-expiratory data, original waveform must be retained for quality control):
- 1) Mean pulmonary artery pressure ≥ 25 mmHg 2) Pulmonary vascular resistance ≥ 3 Wood units 3) Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg 4) Cardiac output measurement requirements: thermal dilution or direct Fick method; indirect Fick method does not meet study criteria.
- 6. Pulmonary function tests meet the following criteria:
- 1） Total lung capacity (TLC) ≥ 60% of the predicted normal value; 2） Forced expiratory volume in the first second (FEV1) ≥ 55% of the predicted normal value; 3） DLCOSB ≥ 40% of the predicted normal value. 7. Baseline 6MWD more than 100 meters repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value) 8. In a resting state, without supplemental oxygen, arterial oxygen saturation (SaO2) ≥ 88%.
- 9. No participation in cardiopulmonary rehabilitation training programs within 12 weeks prior to the screening visit.
- 10. Females of childbearing potential must agree to use contraception until the end of the study.
- 11. No participation in clinical studies involving other investigational drugs or devices throughout the study duration.
- 12. Ability to understand the informed consent form and sign it.
Who cannot join
- 1. Other types of pulmonary arterial hypertension (PAH)
- Other types of PAH, such as HIV-related PAH, schistosomiasis-related PAH, etc.
- Pulmonary arterial hypertension associated with portal hypertension
- Pulmonary vein occlusive disease or pulmonary capillary hemangiomatosis 2. Group 4 PH, e.g. Chronic thromboembolic pulmonary hypertension 3. Group 2 PH, i.e., PH associated with left heart disease 4. Group 3 PH, i.e., PH associated with lung disease or hypoxia 5. Group 5 PH, i.e., PH with unclear mechanisms or multi-mechanism 6. PAH Therapy
- 1) Subjects who have received PAH therapy (such as PDE5 inhibitors, ERAs, or chronic prostacyclin therapy) within 4 weeks prior to the screening visit.
- 2) Subjects who have ever received ERA therapy (e.g., macitentan) or PDE5 inhibitor therapy (e.g., sildenafil) and discontinued due to tolerance issues unrelated to liver dysfunction.
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- 3) Subjects known to have an allergy to the investigational product, its metabolites, or excipients.
- 7. Other Therapies
- Subjects who have received intravenous inotropes (e.g., dobutamine) within 2 weeks prior to the screening visit.
- Subjects receiving protease inhibitors, systemic ketoconazole, or systemic itraconazole therapy.
- Subjects receiving strong CYP3A4 inducers (e.g., rifampicin).
- Subjects who have received unstable doses of calcium channel blockers or HMG-CoA reductase inhibitors (statins) within 4 weeks prior to the screening visit (eligible subjects must not have changed doses within 4 weeks prior to the screening visit).
- Subjects with a history of angina or who have received long-acting or short-acting nitrate treatment within the 12 weeks prior to the visit.
- 8. Laboratory Tests at Screening
- 1） Serum ALT or AST laboratory values > 2 times the upper limit of normal at screening.
- 2） Serum bilirubin laboratory values > 1.5 times the upper limit of normal at screening.
- 3） Severe renal impairment (estimated glomerular filtration rate < 45 mL/min/1.73m3) at screening.
- 9. Medical History/Current Medical Conditions
- Severe liver dysfunction (Child-Pugh Class C, with or without cirrhosis) at screening.
- Significant anemia in the opinion of the investigator.
- History of bleeding disorders or significant active peptic ulcers.
- Uncontrolled hypertension (≥ 180/110 mmHg) at screening.
- Severe hypotension (< 90/50 mmHg) at screening.
- Myocardial infarction within 3 months prior to screening.
- Clinically significant aortic or mitral valve disease, constrictive pericarditis, restrictive or congestive cardiomyopathy, life-threatening arrhythmias, significant left ventricular dysfunction, left ventricular outflow tract obstruction, symptomatic coronary artery disease, autonomic hypotension, or circulatory failure.
- History of non-arteritic anterior ischemic optic neuropathy.
- Hereditary degenerative retinal disease (e.g., retinitis pigmentosa).
- Significant fluid retention in the opinion of the investigator.
- Subjects with cardiovascular, liver, kidney, hematologic, gastrointestinal, immune, endocrine, metabolic, or central nervous system diseases that the investigator believes may adversely affect the subject's safety and/or the efficacy of the investigational product or significantly impact the subject's lifespan.
- History of malignant tumors within the past 5 years, except for those with local, non-metastatic basal cell carcinoma, cervical carcinoma in situ, or prostate cancer who are not anticipated to receive radiotherapy, chemotherapy, and/or surgical interventions or initiate hormonal therapy during the study period.
- Pregnant or breastfeeding female subjects.
- Subjects with demonstrated poor compliance.
- History of alcohol abuse or illicit drug use within 1 year.
- Participation in clinical studies involving another investigational drug or device within 4 weeks prior to the screening visit.
- Subjects who fail inclusion/exclusion criteria may be re-screened once.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310058
Zongye Cai, MD, PhD, 15216621557, z.cai@zju.edu.cn
About this study
Official title: A Multicenter, Randomized, Controlled, Double-blind, and Non-inferiority Clinical Trial to Compare the Efficacy of Sequential to Initial Combination Therapy in Patients With Pulmonary Arterial Hypertension
This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in patients with pulmonary arterial hypertension (PAH). Ambrisentan and Tadalafil will be used in the study. Our research hypothesis is that the efficacy of sequential combination therapy in PAH patients is not inferior to the initial combination therapy as the primary efficacy endpoint is the change in 6MWD at month 12 from baseline.
Read the detailed description
This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in symptomatic patients with PAH (WHO functional class I-III) and assessed as low-risk or moderate-risk based on 2022 ESC/ERS risk stratification. Subjects must not have previously received chronic PAH therapy (i.e., prostanoids, ERAs, or PDE-5 inhibitors) within 4 weeks prior to Screening.
Treatment Escalation
- The investigators will conduct a risk stratification assessment based on COMPERA 2.0 every 4 months, i.e. at month 4, 8, and 12.
- If the patient meets the low-risk criteria, their current treatment regimen will be maintained, and both the patient and the investigator will be unaware of the specific regimen.
- If the patient does not meet the low-risk criteria:
- No clinical failure events have occurred: The first step is to escalate to blinded dual therapy.
- The investigator initiates a request for blinded dual therapy, and the pharmacist informs the investigator that the treatment plan has been upgraded as requested.
- If the patient is currently on mono therapy, the pharmacist will escalate the regimen to dual therapy.
- If the patient is currently in the initial combination therapy group or has already escalated to blinded dual therapy, the pharmacist will maintain the current dual therapy regimen.
- If any clinical failure event occurs at any time, as determined by the Clinical Event Evaluation Committee:
- Escalate to blinded dual therapy as described above
- Or add prostacyclin analogue
- Or add IP receptor agonist
- Or transition of Tadalafil to Riociguat
- Or add Sotatercept
Primary efficacy endpoint is exercise capacity, as the change in 6MWD at month 12 from baseline. Secondary efficacy endpoints will include time to clinical failure events during the 12-month treatment period, and others detailed in outcome measures.
Study duration will be approximately 4 years. A non-inferiority test will be conducted based on the mean difference and 95% CI of the change in 6MWD between groups after 12 months of treatment following randomization. An unblinded, external, independent DSMB will monitor participants' data and safety throughout the course of the study.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- Tadalafil, Ambrisentan, Ambrisentan mimic, Tadalafil mimic
- Keywords
- Sequential combination therapy, Initial combination therapy, Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Target dose 40 mg OD
AmbrisentanDrug
Target dose 10 mg OD
Ambrisentan mimicDrug
Ambrisentan mimic will switch to Ambrisentan if low risk status was not achived at month 4, or 8, or 12.
Tadalafil mimicDrug
Tadalafil mimic will switch to Tadalafil if low risk status was not achived at month 4, or 8, or 12.
| Study group | Role | What they receive |
|---|---|---|
| Initial combination therapy | Active comparator | Patients will receive dual combination therapy with Ambrisentan and Tadalafil immediately after randomization. Receives: Drug: Tadalafil; Drug: Ambrisentan |
| Sequential combination therapy (B1 group) | Experimental | Patients will receive Ambrisentan and Tadalafil mimic first, with sequential addition of Tadalafil if low risk status was not achived at month 4, or 8, or 12. Receives: Drug: Ambrisentan; Drug: Tadalafil mimic |
| Sequential combination therapy (B2 group) | Experimental | Patients will receive Tadalafil and Ambrisentan mimic first, with sequential addition of Ambrisentan if low risk status was not achived at month 4, or 8, or 12. Receives: Drug: Tadalafil; Drug: Ambrisentan mimic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of 6MWD at month 12 from baseline
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT).
Measured: Baseline and Month 12
Secondary outcomes (8)
Time to clinical failure events during the 12-month treatment period.
Definition of Clinical Failure Events:
- Death (all-cause)
- Hospitalization due to worsening PAH (adjudicated)
- Any hospitalization for worsening
- PAH Lung or heart/lung transplantation
- Atrial septostomy
- Initiation of parenteral prostanoid therapy
- Need to initiate rescue therapy <!-- -->
- Switch Tadalafil to Macitentan
- Add Selexipag
- Add Sotatercept
- Disease progression (adjudicated)
- Decrease in 6MWD of more than 15% from baseline
- Concurrent presence of WHO functional class III or IV symptoms (continuously observed in follow-up after baseline with at least 14 days apart)
- Unsatisfactory long-term clinical response (Adjudicated, all criteria must be met)
- Receiving at least one dose of randomized treatment and being in the study for at least 6 months
- A decrease in 6MWD from baseline in two assessments separated by at least 14 days
- WHO functional class III symptoms assessed at two visits separated by > 6 months
Measured: During the 12-month treatment period
Low-risk status achievement rates.
Risk stratification will be assess according to COMPERA 2.0, which includes WHO functional class, 6MWD, and BNP or NT-proBNP.
Measured: Month 4, 8 and 12
The change of NT-proBNP at month 12 from baseline
NT-proBNP is a circulating biomarker that reflects cardiac afterload, this will be measured by central lab.
Measured: Baseline and Month 12
The change of WHO functional class at month 12 from baseline
WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest).
Measured: Baseline and Month 12
The change of pulmonary vascular resistance at month 12 from baseline
Pulmonary vascular resistance is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization.
Measured: Baseline and Month 12
Percentage of subjects receiving mono, dual or triple therapy
Measured: Month 4, 8, and 12
Percentage of subjects with satisfactory clinical response
- An increase of 10% in 6MWD compared to baseline.
- Improvement or maintenance of WHO class I or II symptoms.
- No clinical failure events occurring during the study.
Measured: Month 8, and 12
The change of EmPHasis-10 score from baseline
The EmPHasis-10 questionnaire is used during clinical assessments to estimate how pulmonary hypertension affects patients' life (range: 0=no impact to 5=severe impact). A higher score indicated more severe impact.
Measured: Baseline, Month 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start14 May 2025
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Huzhou Central Hospital, Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Ningbo University, Ningbo No.2 Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, First Affiliated Hospital of Wenzhou Medical University, Shanghai Pulmonary Hospital, Shanghai, China, Taizhou Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, JianAn Wang, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968962
- Sponsor's protocol ID
- YAN2024-1201
- Acronym
- ORIENTATION
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Double-blind, and Non-inferiority Clinical Trial to Compare the Efficacy of Sequential to Initial Combination Therapy in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06968962
- Acronym / sponsor ID
- ORIENTATION / YAN2024-1201
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Sequential combination therapy, Initial combination therapy, Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Huzhou Central Hospital, Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Ningbo University, Ningbo No.2 Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, First Affiliated Hospital of Wenzhou Medical University, Shanghai Pulmonary Hospital, Shanghai, China, Taizhou Hospital, Guangdong Provincial People's Hospital
- Study start
- 14 May 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 May 2025 (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.
This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in patients with pulmonary arterial hypertension (PAH). Ambrisentan and Tadalafil will be used in the study. Our research hypothesis is that the efficacy of sequential combination therapy in PAH patients is not inferior to the initial combination therapy as the primary efficacy endpoint is the change in 6MWD at month 12 from baseline.
Detailed description
This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in symptomatic patients with PAH (WHO functional class I-III) and assessed as low-risk or moderate-risk based on 2022 ESC/ERS risk stratification. Subjects must not have previously received chronic PAH therapy (i.e., prostanoids, ERAs, or PDE-5 inhibitors) within 4 weeks prior to Screening.
Treatment Escalation
- The investigators will conduct a risk stratification assessment based on COMPERA 2.0 every 4 months, i.e. at month 4, 8, and 12.
- If the patient meets the low-risk criteria, their current treatment regimen will be maintained, and both the patient and the investigator will be unaware of the specific regimen.
- If the patient does not meet the low-risk criteria:
- No clinical failure events have occurred: The first step is to escalate to blinded dual therapy.
- The investigator initiates a request for blinded dual therapy, and the pharmacist informs the investigator that the treatment plan has been upgraded as requested.
- If the patient is currently on mono therapy, the pharmacist will escalate the regimen to dual therapy.
- If the patient is currently in the initial combination therapy group or has already escalated to blinded dual therapy, the pharmacist will maintain the current dual therapy regimen.
- If any clinical failure event occurs at any time, as determined by the Clinical Event Evaluation Committee:
- Escalate to blinded dual therapy as described above
- Or add prostacyclin analogue
- Or add IP receptor agonist
- Or transition of Tadalafil to Riociguat
- Or add Sotatercept
Primary efficacy endpoint is exercise capacity, as the change in 6MWD at month 12 from baseline. Secondary efficacy endpoints will include time to clinical failure events during the 12-month treatment period, and others detailed in outcome measures.
Study duration will be approximately 4 years. A non-inferiority test will be conducted based on the mean difference and 95% CI of the change in 6MWD between groups after 12 months of treatment following randomization. An unblinded, external, independent DSMB will monitor participants' data and safety throughout the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Initial combination therapy | Active comparator | Drug: Tadalafil, Drug: AmbrisentanPatients will receive dual combination therapy with Ambrisentan and Tadalafil immediately after randomization. |
| Sequential combination therapy (B1 group) | Experimental | Drug: Ambrisentan, Drug: Tadalafil mimicPatients will receive Ambrisentan and Tadalafil mimic first, with sequential addition of Tadalafil if low risk status was not achived at month 4, or 8, or 12. |
| Sequential combination therapy (B2 group) | Experimental | Drug: Tadalafil, Drug: Ambrisentan mimicPatients will receive Tadalafil and Ambrisentan mimic first, with sequential addition of Ambrisentan if low risk status was not achived at month 4, or 8, or 12. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age between 18 to 80 years and weight ≥ 40 kg.
- WHO functional classification I-III.
- Diagnosed with PAH caused or related to the following:
- Connective tissue diseases (e.g., scleroderma, systemic lupus erythematosus, mixed connective tissue disease, etc.)
- Drug or toxin exposure
Key exclusion criteria (35 listed)
- 1. Other types of pulmonary arterial hypertension (PAH)
- 1) Subjects who have received PAH therapy (such as PDE5 inhibitors, ERAs, or chronic prostacyclin therapy) within 4 weeks prior to the screening visit.
- 2) Subjects who have ever received ERA therapy (e.g., macitentan) or PDE5 inhibitor therapy (e.g., sildenafil) and discontinued due to tolerance issues unrelated to liver dysfunction.
- 3) Subjects known to have an allergy to the investigational product, its metabolites, or excipients.
- 7. Other Therapies
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 |
|---|---|---|
| TadalafilTarget dose 40 mg OD | Drug | Initial combination therapy, Sequential combination therapy (B2 group) |
| AmbrisentanTarget dose 10 mg OD | Drug | Initial combination therapy, Sequential combination therapy (B1 group) |
| Ambrisentan mimicAmbrisentan mimic will switch to Ambrisentan if low risk status was not achived at month 4, or 8, or 12. | Drug | Sequential combination therapy (B2 group) |
| Tadalafil mimicTadalafil mimic will switch to Tadalafil if low risk status was not achived at month 4, or 8, or 12. | Drug | Sequential combination therapy (B1 group) |
Primary outcome
The change of 6MWD at month 12 from baseline
Time frame: Baseline and Month 12
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT).
8 secondary outcomes
Time to clinical failure events during the 12-month treatment period.
Time frame: During the 12-month treatment period
Low-risk status achievement rates.
Time frame: Month 4, 8 and 12
The change of NT-proBNP at month 12 from baseline
Time frame: Baseline and Month 12
The change of WHO functional class at month 12 from baseline
Time frame: Baseline and Month 12
The change of pulmonary vascular resistance at month 12 from baseline
Time frame: Baseline and Month 12
Percentage of subjects receiving mono, dual or triple therapy
Time frame: Month 4, 8, and 12
Percentage of subjects with satisfactory clinical response
Time frame: Month 8, and 12
The change of EmPHasis-10 score from baseline
Time frame: Baseline, Month 4, 8, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tadalafil, Ambrisentan and Ambrisentan mimic in people with Pulmonary Arterial Hypertension (PAH), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 15 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zongye Cai, MD, PhD (+8618258236820, z.cai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of 6MWD at month 12 from baseline (time frame: Baseline and Month 12). 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 29 Jul 2025.