Fibrosing MediastinitisACCT-NOPHNCT06980584
Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
A study testing Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention and Pulmonary Vascular Interventional Therapy in people with Fibrosing Mediastinitis and Pulmonary Hypertension, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Through a randomized controlled trial (RCT) design, this study aiming to evaluated the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular interventional therapy in treating fibrosing mediastinal pulmonary hypertension (FM-PH).Eligible participants were randomly assigned to either… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fibrosing Mediastinitis, Pulmonary Hypertension
- What is being tested?
- Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention and Pulmonary Vascular Interventional Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 31 Oct 2027
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years.
- The patient presented with symptoms of chest tightness, shortness of breath, and reduced exercise tolerance.
- Chest CT revealed mediastinal lymph node compression of the pulmonary artery, with evidence of pulmonary hypertension consistent with the patient's symptoms.
- The subject signed the informed consent form prior to participation and is able to comply with the study protocol and one-year follow-up.
Who cannot join
- Currently in the active phase of infection, including but not limited to tuberculosis, Histoplasma capsulatum, and Aspergillus infections;
- The underlying primary disease, such as sarcoidosis, Behcet's disease, or uncontrolled IgG4-related disease, is currently not well controlled.
- Before treatment, a large amount of pleural effusion was still present.
- Pulmonary function tests (PFT) showed FEV1 <30% of the predicted value, FEV1/FVC <30%, and DLCO <30%.
- There are contraindications to bronchoscopy or endovascular intervention.
- Complicated by other end-stage organ dysfunction, such as Child-Pugh class C liver function or stage IV chronic renal failure.
- Complicated by severe immunosuppression.
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
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Juanni Gong, 15801511482, juannigong2018@126.com
About this study
Official title: Analysis of Clinical Characteristics and Follow-Up Study on Treatment of Nonthrombotic Obstructive Pulmonary Hypertension: Interventional Study
Through a randomized controlled trial (RCT) design, this study aiming to evaluated the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular interventional therapy in treating fibrosing mediastinal pulmonary hypertension (FM-PH).Eligible participants were randomly assigned to either the combined treatment group, receiving both pulmonary vascular intervention and rituximab lymph node injection, or the interventional-only group, which received pulmonary vascular intervention alone. At 3, 6, and 12 months post-treatment, the efficacy was assessed based on symptom improvement, hemodynamic changes, lesion volume reduction, etc. Safety was mainly evaluated by comparing adverse event incidence between the two groups.
- Conditions
- Fibrosing Mediastinitis, Pulmonary Hypertension
- Being tested
- Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention, Pulmonary Vascular Interventional Therapy
- Keywords
- Rituximab, Endobronchial Ultrasound, Pulmonary Vascular Intervention
- Medical subject headings
- Mediastinal Fibrosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab Lymph Node Injection Combined with Pulmonary Vascular InterventionProcedure or surgery
Based on the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed vessels. During the treatment cycle, one lymph node drug injection is administered: 50mg of rituximab is dissolved in 15ml of 5% glucose solution and injected at multiple sites into the identified enlarged mediastinal lymph nodes under ultrasound-guided bronchoscopy.
Pulmonary Vascular Interventional TherapyProcedure or surgery
According to the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed pulmonary vessels.
| Study group | Role | What they receive |
|---|---|---|
| Combined treatment group | Experimental | Participants assigned to this group will receive both pulmonary vascular intervention and rituximab lymph node injection. Receives: Procedure: Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention |
| Interventional-only group | Active comparator | Participants assigned to this group will receive pulmonary vascular intervention alone. Receives: Procedure: Pulmonary Vascular Interventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Six Minutes Walk Distance at 12 Months.
Conduct 6-minute walk test to measure the 6-minute walk distance, and compare the walking distances at baseline and 12 months after treatment.
Measured: From enrollment to the end of treatment at 12 months
The incidence of treatment-related serious adverse events (SAE)
The incidence of treatment-related serious adverse events is measured by tracking and documenting any SAEs that occur during the treatment period, as well as through follow-up assessments. Each event is evaluated for severity and causality, and the incidence is calculated by dividing the number of patients who experience at least one treatment-related SAE by the total number of treated patients.
Measured: During the one-year follow-up period after treatment completion
Secondary outcomes (14)
Change from baseline in the World Health Organization Functional Classification of Pulmonary Hypertension at 3, 6 and 12 months.
Change from Baseline in the World Health Organization Functional Classification of Pulmonary Hypertension (WHO-FC) which assessed based on clinical symptoms and signs at baseline and the end of treatment at 3, 6 and 12 months. The WHO-FC system consists of four levels: I, II, III, and IV. Higher levels indicate progressively more severe conditions.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months.
Change from Baseline in the mean pulmonary artery pressure (mPAP) at 3 and 12 Months.
The mean pulmonary artery pressure (mPAP) was measured by right heart catheterization to evaluate the hemodynamic change from baseline to the end of treatment at 3 and12 months.
Measured: From enrollment to the end of treatment at 3 and12 months
Change from Baseline in the Cardiac Index (CI) at 3 and 12 Months.
The Cardiac Index (CI) was measured by right heart catheterization to evaluate the hemodynamic change from baseline to the end of treatment at 3 and12 months.
Measured: From enrollment to the end of treatment at 3 and12 months
Change from Baseline in the Pulmonary Vascular Resistance (PVR) at 3 and 12 Months.
The Pulmonary Vascular Resistance (PVR) was measured by right heart catheterization to evaluate the hemodynamic change from baseline to the end of treatment at 3 and12 months.
Measured: From enrollment to the end of treatment at 3 and12 months
Change from Baseline in the forced vital capacity (FVC) at 3, 6 and 12 Months.
Pulmonary function tests was performed, including the forced vital capacity (FVC), to evaluated pulmonary function at baseline and the end of treatment at 3, 6 and 12 Months.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the forced vital capacity of predicted (FVC%pred) at 3, 6 and 12 Months.
Pulmonary function tests was performed, including the forced vital capacity of predicted (FVC%pred), to evaluated pulmonary function at baseline and the end of treatment at 3, 6 and 12 Months.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the forced expiratory volume in 1 second (FEV1) at 3, 6 and 12 Months.
Pulmonary function tests was performed, including the forced expiratory volume in 1 second (FEV1), to evaluated ventilation function at baseline and the end of treatment at 3, 6 and 12 Months.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the forced expiratory volume in 1 second of predicted (FEV1%pred) at 3, 6 and 12 Months.
Pulmonary function tests was performed, including the forced expiratory volume in 1 second of predicted (FEV1%pred), to evaluated ventilation function at baseline and the end of treatment at 3, 6 and 12 Months.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the FEV1/FVC ratio at 3, 6 and 12 Months.
Pulmonary function tests was performed, including the FEV1/FVC ratio, to evaluated ventilation function at baseline and the end of treatment at 3, 6 and 12 Months.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months
Change of the BNP/NT-Pro BNP from baseline to the end of treatment at 3, 6 and 12 months.
The BNP/NT-Pro BNP will be measured at baseline the end of treatment at 3, 6 and 12 months to evaluate the condition of heart failure.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months.
The restenosis rate of blood vessels after interventional therapy at the end of treatment at 3 and 12 months
Restenosis following interventional therapy was monitored at the end of treatment at 3 and 12 months, with restenosis defined as a blood vessel diameter reduction of more than 50% from the original size, or when the pressure gradient (Pd) at the site of vascular stenosis increases by 5 mmHg or more compared to the last measurement.
Measured: From enrollment to the end of treatment at 3 and 12 months.
Change of the mediastinal lesion volume from baseline to 3 and 12 months after the end of treatment.
The mediastinal lesion volume will be measured at baseline and 3, 12 months after the end of treatment using CTPA or PET-CT imaging. The volume is represented by the maximum transverse diameter of the cross-section of the lesion site.
Measured: From enrollment to the end of treatment at 3 and12 months.
Change from baseline of the quality-of-life score at 3, 6 and 12 months after the end of treatment.
Quality of life was assessed using the 36-Item Short-Form Health Survey (SF-36) at baseline and 3, 6 and 12 months after the end of treatment. The SF-36 scoring scale consists of 8 dimensions, which can be summarized as physical health and mental health. The score range of each dimension is 0 to 100 points. The higher the score, the better the health condition.
Measured: From enrollment to the end of treatment at 3, 6 and 12 months
Number of participants with complications of bronchoscopy and pulmonary intervention.
Measure the probability of complications occurring during or after therapeutic operations. Complications of pulmonary vascular intervention include pulmonary vascular injury, arrhythmia, reperfusion pulmonary edema, etc; Complications of bronchoscopy include pneumothorax, massive hemoptysis, infection, etc.
Measured: Immediately or in the short term after treatment, and within 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start10 Feb 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibrosing MediastinitisStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980584
- Sponsor's protocol ID
- 2025-KE-61_Int
- Acronym
- ACCT-NOPH
- Status last verified
- Feb 2025
- First submitted
- 27 Apr 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia M, Su H, Jiang K, Wang A, Guo Z, Zhu H, Zhang F, Sun X, Shi Y, Pan X, Cao Y. Incidence and predictors of in-stent restenosis following intervention for pulmonary vein stenosis due to fibrosing mediastinitis. Orphanet J Rare Dis. 2024 Oct 14;19(1):379. doi: 10.1186/s13023-024-03391-8.
PubMed 39397011Varghese C, Johnson GB, Eiken PW, Edell ES, Specks U, Larson NB, Peikert T. A Retrospective Evaluation of the Treatment Effects of Rituximab in Patients with Progressive and Symptomatic Fibrosing Mediastinitis. Ann Am Thorac Soc. 2024 Nov;21(11):1533-1541. doi: 10.1513/AnnalsATS.202405-533OC.
PubMed 39106522
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Characteristics and Follow-Up Study on Treatment of Nonthrombotic Obstructive Pulmonary Hypertension: Interventional Study
- ClinicalTrials.gov ID
- NCT06980584
- Acronym / sponsor ID
- ACCT-NOPH / 2025-KE-61_Int
- Conditions
- Fibrosing Mediastinitis, Pulmonary Hypertension
- Keywords
- Rituximab, Endobronchial Ultrasound, Pulmonary Vascular Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 20 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.
Through a randomized controlled trial (RCT) design, this study aiming to evaluated the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular interventional therapy in treating fibrosing mediastinal pulmonary hypertension (FM-PH).Eligible participants were randomly assigned to either the combined treatment group, receiving both pulmonary vascular intervention and rituximab lymph node injection, or the interventional-only group, which received pulmonary vascular intervention alone. At 3, 6, and 12 months post-treatment, the efficacy was assessed based on symptom improvement, hemodynamic changes, lesion volume reduction, etc. Safety was mainly evaluated by comparing adverse event incidence between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined treatment group | Experimental | Procedure: Rituximab Lymph Node Injection Combined with Pulmonary Vascular InterventionParticipants assigned to this group will receive both pulmonary vascular intervention and rituximab lymph node injection. |
| Interventional-only group | Active comparator | Procedure: Pulmonary Vascular Interventional TherapyParticipants assigned to this group will receive pulmonary vascular intervention alone. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years.
- The patient presented with symptoms of chest tightness, shortness of breath, and reduced exercise tolerance.
- Chest CT revealed mediastinal lymph node compression of the pulmonary artery, with evidence of pulmonary hypertension consistent with the patient's symptoms.
- The subject signed the informed consent form prior to participation and is able to comply with the study protocol and one-year follow-up.
Key exclusion criteria (7 listed)
- Currently in the active phase of infection, including but not limited to tuberculosis, Histoplasma capsulatum, and Aspergillus infections;
- The underlying primary disease, such as sarcoidosis, Behcet's disease, or uncontrolled IgG4-related disease, is currently not well controlled.
- Before treatment, a large amount of pleural effusion was still present.
- Pulmonary function tests (PFT) showed FEV1 <30% of the predicted value, FEV1/FVC <30%, and DLCO <30%.
- There are contraindications to bronchoscopy or endovascular intervention.
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 |
|---|---|---|
| Rituximab Lymph Node Injection Combined with Pulmonary Vascular InterventionBased on the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed vessels. During the treatment cycle, one lymph node drug injection is administered: 50mg of rituximab is dissolved in 15ml of 5% glucose solution and injected at multiple sites into the identified enlarged mediastinal lymph nodes under ultrasound-guided bronchoscopy. | Procedure or surgery | Combined treatment group |
| Pulmonary Vascular Interventional TherapyAccording to the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed pulmonary vessels. | Procedure or surgery | Interventional-only group |
Primary outcome
Change from Baseline in the Six Minutes Walk Distance at 12 Months.
Time frame: From enrollment to the end of treatment at 12 months
Conduct 6-minute walk test to measure the 6-minute walk distance, and compare the walking distances at baseline and 12 months after treatment.
The incidence of treatment-related serious adverse events (SAE)
Time frame: During the one-year follow-up period after treatment completion
The incidence of treatment-related serious adverse events is measured by tracking and documenting any SAEs that occur during the treatment period, as well as through follow-up assessments. Each event is evaluated for severity and causality, and the incidence is calculated by dividing the number of patients who experience at least one treatment-related SAE by the total number of treated patients.
14 secondary outcomes
Change from baseline in the World Health Organization Functional Classification of Pulmonary Hypertension at 3, 6 and 12 months.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months.
Change from Baseline in the mean pulmonary artery pressure (mPAP) at 3 and 12 Months.
Time frame: From enrollment to the end of treatment at 3 and12 months
Change from Baseline in the Cardiac Index (CI) at 3 and 12 Months.
Time frame: From enrollment to the end of treatment at 3 and12 months
Change from Baseline in the Pulmonary Vascular Resistance (PVR) at 3 and 12 Months.
Time frame: From enrollment to the end of treatment at 3 and12 months
Change from Baseline in the forced vital capacity (FVC) at 3, 6 and 12 Months.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the forced vital capacity of predicted (FVC%pred) at 3, 6 and 12 Months.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the forced expiratory volume in 1 second (FEV1) at 3, 6 and 12 Months.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the forced expiratory volume in 1 second of predicted (FEV1%pred) at 3, 6 and 12 Months.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months
Change from Baseline in the FEV1/FVC ratio at 3, 6 and 12 Months.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months
Change of the BNP/NT-Pro BNP from baseline to the end of treatment at 3, 6 and 12 months.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months.
The restenosis rate of blood vessels after interventional therapy at the end of treatment at 3 and 12 months
Time frame: From enrollment to the end of treatment at 3 and 12 months.
Change of the mediastinal lesion volume from baseline to 3 and 12 months after the end of treatment.
Time frame: From enrollment to the end of treatment at 3 and12 months.
Change from baseline of the quality-of-life score at 3, 6 and 12 months after the end of treatment.
Time frame: From enrollment to the end of treatment at 3, 6 and 12 months
Number of participants with complications of bronchoscopy and pulmonary intervention.
Time frame: Immediately or in the short term after treatment, and within 12 months after treatment
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 23 May 2025.
- Background: PubMed 39397011Jia M, Su H, Jiang K, Wang A, Guo Z, Zhu H, Zhang F, Sun X, Shi Y, Pan X, Cao Y. Incidence and predictors of in-stent restenosis following intervention for pulmonary vein stenosis due to fibrosing mediastinitis. Orphanet J Rare Dis. 2024 Oct 14;19(1):379. doi: 10.1186/s13023-024-03391-8.
- Background: PubMed 39106522Varghese C, Johnson GB, Eiken PW, Edell ES, Specks U, Larson NB, Peikert T. A Retrospective Evaluation of the Treatment Effects of Rituximab in Patients with Progressive and Symptomatic Fibrosing Mediastinitis. Ann Am Thorac Soc. 2024 Nov;21(11):1533-1541. doi: 10.1513/AnnalsATS.202405-533OC.
- Individual participant dataSharing planned: No
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 Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention and Pulmonary Vascular Interventional Therapy in people with Fibrosing Mediastinitis and Pulmonary Hypertension, run by Beijing Chao Yang Hospital 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 7 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 23 May 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 Juanni Gong, Doctor of Medicine (15801511482, juannigong2018@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Six Minutes Walk Distance at 12 Months. (time frame: From enrollment to the end of treatment at 12 months). The study lists 2 primary outcomes in all. 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 NCT06980584, which also lists 2 linked publications.
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 23 May 2025.