Health TrialsbyHealthPanel

Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis

ConditionIdiopathic Pulmonary Fibrosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity of Alabama at Birmingham

About this trial

This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 40-85 years old.

A diagnosis of IPF that fulfills latest ATS/ERS Consensus Criteria.

A diagnosis of Progressive IPF (P-IPF), defined as a relative decrease of FVC%p >10% during the preceding twelve months, and substantiated by replicate values at least three weeks apart.

Ability and willingness to give informed consent (no surrogates) and adhere to requirements.

Disqualifiers

Diagnoses of current infection by clinical or microbial assessments.

Diagnoses of an additional or alternative etiology for lung dysfunction based upon clinical assessment, including sepsis, congestive heart failure, thromboembolism, worsened pulmonary artery hypertension, etc. using routine clinical evaluations under direction of the attending physician.

History or serologic evidence of hepatitis B or C infection. Positive serology for Hepatitis C will not exclude patients if their circulating HC virus RNA test is negative.

Coagulopathy, defined as an INR >1.6, PTT >2x control, fibrinogen <100 mg/dL, or platelet count <50,000 unless these abnormalities can be reversed.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Plasma Exchange

    Other intervention

    Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma

  • Rituximab

    Drug

    Infusion of humanized mouse monoclonal antibody with specificity for human CD20

  • Intravenous immunoglobulin

    Drug

    intravenous infusions of normal human immunoglobulin

  • Treatment as Usual

    Drug

    Continued therapy with conventional, approved, specific IPF medications

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Autoantibody Reduction Therapy (AART)Experimental treatment 3 interventions
Group B: Treatment as Usual (TAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Forced Vital Capacity (FVC)

Intergroup comparisons of FVC changes over duration of observations

Time frame
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)

Secondary outcomes

1

Supplemental Oxygen Requirements (O2)

Intergroup comparisons of changing O2 requirements over duration of observations

Time frame
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
2

Six-minute walk distances (6MWD)

Intergroup comparisons of changes of 6MWD over duration of observations

Time frame
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
3

Durations of progression-free survival

Intergroup comparisons of number who survive without \>5% decrements of FVC as percent of predicted normal values

Time frame
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
4

Composite outcome measure

Absolute numbers of acute IPF exacerbations or all cause deaths or unscheduled hospitalizations

Time frame
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: