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Rituximab Therapy in Patients With Treatment Refractory Hypersenstivity Pneumonitis

NCT07035561 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-25

No results posted yet for this study

Summary

Hypersensitivity pneumonitis (HP) presents with a highly variable clinical course, and Traditional treatment involves systemic corticosteroids in conjunction with strict avoidance of the offending antigen. However, a subset of patients with progressive disease remains unresponsive to conventional therapies. The objective of this study is to evaluate the therapeutic potential of Rituximab in individuals with refractory hypersensitivity pneumonitis who did not respond to conventional immunosuppressive therapy and antigen avoidance.

Assessing FVC at three intervals: six months prior to the initiation of Rituximab therapy (M-6), at the time of treatment initiation (M0), and six months afterward (M+6).

Conditions

  • Hypersenstivity Pneumonitis
  • ILD

Interventions

DRUG

Rituximab (Mabthera)

In Chronic hypersensitivity pneumonitis patients with no improvement in lung function (deterioration in their FVC% predicted more than or equal 5%) after a minimum of 6 months treatment including antigen avoidance and immunosuppressive therapy. Rituximab will be administered by an intravenous infusion. * Two doses of Rituximab will be given, the first dose at day 0 and the second dose at day 15, 1 gram of Rituximab will be given in each dose. * Patients will be given acetaminophen and antihistamine before each infusion. * Rituximab will be diluted in an infusion bag of either 0.9% sodium chloride or 5% dextrose. * No other drugs will be mixed with it, and patients will be closely monitored for any infusion reactions.

Sponsors & Collaborators

  • Shereen Medhat Mohammed Elsayed Nassar

    lead OTHER

Principal Investigators

  • Yosri M. Akl, Professor of Chest Diseases · Cairo University

  • Safy Z. Kaddah, Professor of Chest Diseases · Cairo University

  • Rana K Gabr, MD in Chest Diseases · Cairo University

  • Sherin M. Nassar, MSc in Chest Diseases · Cairo University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035561 on ClinicalTrials.gov