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Status unknownNCT02126098Updated Apr 29, 2014

Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis

An observational study in ANCA-associated Vasculitis, Granulomatosis With Polyangiitis and Microscopic Polyangiitis, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-04-29.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to observe the clinical manifestation, Lab findings including chest CT scans, pathological findings and outcomes in chinese patients with pulminary vasculitis.

Read the detailed description

Presentation of patient with suspected vasculitis

  1. Established diagnosis Clinical findings Laboratory workup Tissue biopsy Angiogram where appropriate
  2. Evaluating respiratory system Chest HRCT Pulmonary function test Bronchoscopy exam(BALF, TBB) Lung biopsy(needle biopsy, VAST)
  3. screening underlying damage to other system Paranasal sinus, vision \& audition Nervous system Kidney Gastrointestinal tract Heart \& vessel Skin Hematology Muscle, bone \& joint
  4. Treatment
  5. Prognosis

Evaluation

  1. Study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months.
  2. Disease activity was measured on the basis of the BVAS/WG and the physician's global assessment.
  3. Damage related to disease or treatment was scored according to the Vasculitis Damage Index (scores for this index range from 0 to 64, with higher scores in- dicating more severe damage).
  4. Health related quality of life was scored with the use of the Med- ical Outcomes Study 36-Item Short-Form Health Survey (SF-36).Scores on this scale range from 0 to 100, with higher scores indicating better health.
  5. Serial serum samples were tested for proteinase 3-ANCA and myeloperoxidase-ANCA by means of a direct enzyme-linked immunosorbent assay (ELISA).
02

Conditions studied

  • ANCA-associated Vasculitis
  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis
  • EosinphilicGranulomatosis With Polyangiitis

Keywords

  • ANCA-associated vasculitis
  • Granulomatosis with polyangiitis
  • Microscopic polyangiitis
  • Wegner's granulomatosis
  • Eosinphilic granulomatosis with polyangiitis
03

In context

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

142 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 72 are open to participants now.

This study's planned enrollment of 100 is below the median of 133 across 32 observational studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.

Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Peking Union Medical College Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who newly diagnosed ANCA-vasculitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males and Females
  • Aged from 18-75 years with informed consent

  • Patients with ANCA-vasculitis

    1. Wegener's granulomatosis, microscopic polyangiitis or CSS
    2. positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA
    3. manifestations of activity disease, and Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease)

Exclusion criteria

Exclusion Criteria:

  • Females planning to bear a child recently or with childbearing potential
  • Secondary vasculitis, cancer,infective disease or drug induced vasculitis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
30 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adults who diagosed ANCA-vasculitis

    Patients with Wegener's granulomatosis or microscopic polyangiitis were eligible to participate in the study if they had 1. Positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA 2. manifestations of severe disease,11 and a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease)

06

What researchers measure

Primary outcomes

  1. Completely Remission

    BVAS/WG of 0 and successful completion of the prednisone taper at 6 months.

    Time frame: 6 months

Secondary outcomes

  1. Disease flare

    Disease flare 1. an increase in the BVAS/WG of 1 point or more. 2. Patients were classified as having early treatment failure if at 1 month their BVAS/WG had not decreased by at least 1 point or a new manifestation of disease had emerged.

    Time frame: during the period of observation(30months)

Other outcomes

  1. Adverse events

    1. deaths (from all causes) 2. malignant conditions 3. grade 2 or higher leukopenia or thrombocytopenia 4. grade 3 or higher infections 5. drug induced cystitis 6. venous thromboembolic events 7. stroke 8. hospitalizations

    Time frame: during the period of observation (30months)

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of Nov 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2014
First posted
Apr 29, 2014
Start
May 2014
Primary completionEst.
Nov 2017
CompletionEst.
Dec 2017
Last update
Apr 29, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02126098
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Apr 29, 2014
Start date
May 2014
Primary completion
Nov 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Apr 29, 2014

Study contacts

Juhong Shi, M.D
Contact
juhong_shi@hotmail.com
+861069155028
Ling Qin, M.D
Contact
qinlingpumch@126.com
+861069155028
Juhong Shi, M.D
study chair · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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