Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease
- Conditions
- Pulmonary arterial hypertension associated with connective tissue disease
- Registration Number
- JPRN-UMIN000016320
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
1)Patients with pulmonary hypertension associated with left heart disease, chronic thromboembolic pulmonary hypertension, respiratory disease, and hypoxia 2)Patients with vasodilators (endothelin receptor antagonists, prostacyclin analogues and phosphodiesterase 5 inhibitors) started, or the dosage of the vasodilators changed within 4 weeks before the trial 3)Patients with malignancies or malignancy history within 5 years 4)Patients with sever liver diseases (AST(GOT) or ALT(GPT) over 100 U/L) 5)Patients with sever kidney diseases (serum creatinine over 3.0 mg/dL) 6)Patients with sever heart diseases 7)Patients with apparent active infectious diseases 8)Patients with hepatitis B virus carrier (patients with positive HBs antibody or HBc antibody should be monitored on their HBV-DNA monthly.(Exclude patients with history of HBV vaccination)) 9)Patients with history of serious infectious diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Estimated right ventricular systolic pressure (echocardiography) and mean pulmonary arterial pressure (right heart catheterization) Safety: Adverse events and laboratory tests
- Secondary Outcome Measures
Name Time Method