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Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations

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ClinicalTrials.gov Identifier: NCT01266317
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : January 24, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Donahoe, University of Pittsburgh

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: IPF
Intervention: Drug: Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Combined PEX, Rituximab and Steroids

Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.

Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.

Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.

Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab


Participant Flow:   Overall Study
    Combined PEX, Rituximab and Steroids
STARTED   9 [1] 
COMPLETED   7 
NOT COMPLETED   2 
Withdrawal by Subject                2 
[1] One additional patient was a protocol violation post consent when autoantibodies returned positive



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Combined PEX, Rituximab and Steroids

Standard Steroid Treatment: One gm of methylprednisolone I.V., on day 0, followed by 40 mg/day I.V. on days 1-4, and days 6-12 (or the P.O. prednisone equivalent). Methylprednisolone 100 mg I.V. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone I.V. (or P.O. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the principle investigator.

Plasma exchange (PEX) will consist of 1.5x estimated plasma volume exchanges for 3 successive days (0, 1,2) and then, after a one day interval to enable equilibration of autoantibodies sequestered in tissues, two more daily treatments on days 4 and 5.

Rituximab: One gm I.V. will be administered on day 5 (after completion of the last PEX) and day 13.

Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids: Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab


Baseline Measures
   Combined PEX, Rituximab and Steroids 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   6 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   3 
Male   6 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   9 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures

1.  Primary:   Number of Participants With Respiratory and/or Hemodynamic Deteriorations   [ Time Frame: 28 days ]

2.  Secondary:   Number of Participants Survived to 60 Days or to Transplantation   [ Time Frame: 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a pilot, open-label trial of an unprecedented regimen for a highly lethal disease and, as such, included only small numbers of subjects and historical controls.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Donahoe
Organization: University of Pittsburgh
phone: 412-383-2049
e-mail: donahoem@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Donahoe, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01266317     History of Changes
Other Study ID Numbers: PRO10110151
First Submitted: December 22, 2010
First Posted: December 24, 2010
Results First Submitted: December 31, 2017
Results First Posted: January 24, 2018
Last Update Posted: March 14, 2018