IPF Clinical Trial
Official title:
Open-Label, Feasibility Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations
Verified date | February 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label Phase I/II trial to assess the feasibility and safety of combined
plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the
outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this
study are:
1. To assess the feasibility and safety of combined PEX, rituximab, and conventional
corticosteroid administrations for the treatment of hospitalized patients with acute IPF
exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function
during the treatment interval.
2. To assess the efficacy of combined PEX, rituximab, and conventional corticosteroid
administrations for the treatment of hospitalized patients with acute IPF exacerbations
on patient survival in comparison to historical controls. Patient survival for this
investigation will be defined using the composite outcome of 60 day survival and/or
survival to lung transplantation.
Subjects between 18 and 80 years of age who have a confirmed diagnosis of IPF, and meet all
the study requirements will be enrolled in this study. A total of 10 subjects of both genders
and all ethnic backgrounds with acute IPF exacerbations hospitalized at University of
Pittsburgh Medical Center will be enrolled in this study.
Status | Completed |
Enrollment | 9 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - A diagnosis of idiopathic pulmonary fibrosis that fulfills American Thoracic Society Consensus Criteria. - Unexplained worsening or development of dyspnea or hypoxemia within 30 days leading to the current hospitalization. - Radiographic imaging showing ground-glass abnormality and/or consolidation superimposed on a background of reticular or honeycomb pattern consistent with usual interstitial pneumonia. - Intent on the part of the treating physician to use high dose steroid therapy as a therapeutic effort to treat a diagnosis of acute IPF exacerbation. Exclusion Criteria: - Diagnosis of documented infection based upon clinical evaluation and microbial testing. - Diagnosis of thromboembolic disease by clinical assessment. - Diagnosis of an additional etiology for Acute Lung Injury/Acute Respiratory Distress Syndrome based upon clinical assessment to include sepsis, aspiration, trauma, inhalational injury, acute pancreatitis, drug toxicity, blood product transfusion reaction, or stem cell transplantation. - Diagnosis of congestive heart failure that accounts for the hypoxemia. - Presence of active hepatitis B infection. - Coagulopathy defined as an International Normalized Ratio > 1.8, Partial Thromboplastin Time > 2 x control, and platelet count < 50,000. - Hyperosmolar state or diabetic ketoacidosis to suggest uncontrolled diabetes mellitus or uncontrolled hypertension (systolic BP > 160 mm Hg and diastolic BP > 100 mm Hg) which would contraindicated the use of corticosteroids. - Hemodynamic instability defined as a vasopressor requirement which would contraindicate the use of plasmapheresis. - History of reaction to blood products, murine-derived products, or prior exposures to human-murine chimeric antibodies, - History of malignancy. - Inability or unwillingness to accept a blood transfusion. - Inability or unwillingness to complete post- treatment surveillance for 60 days. - Diagnosis of major comorbidities expected to interfere with subjects study participation for 60 days. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Michael Donahoe |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Respiratory and/or Hemodynamic Deteriorations | To assess the feasibility and safety of combined PEX, rituximab, and conventional corticosteroid administrations for the treatment of hospitalized patients with acute IPF exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function during the treatment interval. Respiratory deterioration was defined by a compilations of respiratory deteriorations (deteriorating gas exchange) and hemodynamic deteriorations (defined as a need for medical intervention). | 28 days | |
Secondary | Number of Participants Survived to 60 Days or to Transplantation | The secondary outcome measures a composite outcome defined as survival to 60 days or survival to transplantation at any time post therapy. | 60 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05570058 -
Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
Recruiting |
NCT02807025 -
Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
|
N/A | |
Recruiting |
NCT05895565 -
A Multiple Ascending Doses (MAD) Study of PMG1015 in Idiopathic Pulmonary Fibrosis Subjects
|
Phase 1 | |
Completed |
NCT03211507 -
Idiopathic Pulmonary Fibrosis Job Exposures Study
|
||
Completed |
NCT02503657 -
Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 2 | |
Recruiting |
NCT03873298 -
Inhaled NO in IPF and COPD During 6 Minute Walk Test
|
Phase 2 | |
Terminated |
NCT03864328 -
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
|
Phase 2 | |
Completed |
NCT05803850 -
A Study to Evaluate the Safety, Tolerability, PK and PD of HNC1058
|
Phase 1 | |
Withdrawn |
NCT05349760 -
A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
Recruiting |
NCT05147597 -
Turkish Validity and Reliability of SGRQ-I
|
||
Completed |
NCT04503044 -
ILAs in CT Lung Cancer Screening Population
|
||
Recruiting |
NCT04564183 -
Advancing Prevention of Pulmonary Fibrosis
|
||
Recruiting |
NCT05190211 -
Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis
|
N/A | |
Recruiting |
NCT04263727 -
A Study of Patients With Chronic Disease
|
||
Completed |
NCT05353556 -
Effects of Home-based Inspiratory Muscle Training in Patients With IPF
|
N/A | |
Completed |
NCT02976935 -
Functional MR Lung Imaging Using Hyperpolarised 129Xe
|
||
Recruiting |
NCT05193136 -
Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease
|
||
Recruiting |
NCT06181370 -
Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF
|
Phase 1 | |
Not yet recruiting |
NCT02885961 -
The Coagulation Cascade in Idiopathic Pulmonary Fibrosis
|
N/A | |
Completed |
NCT02151435 -
Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis
|
N/A |