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Efficacy and Safety of Pirfenidone Treatment in HPS-ILD

NCT04193592 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-12-10

No results posted yet for this study

Summary

This research study will explore the safety and efficacy of the drug, pirfenidone, in patients with a diagnosis of Hermansky-Pudlak Syndrome (HPS) who have an associated interstitial lung disease (ILD) over a planned period of 56 weeks.

Conditions

Interventions

DRUG

Pirfenidone

Pirfenidone will be titrated over 14 days, as tolerated, to the full dose of 2403 mg per day, as follows: Days 1 - 7: one capsule TID; Days 8 - 14: two capsules TID; Days 15 to week 52: three capsules TID. Dose may be reduced to manage an adverse event.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Jesse Roman

    lead OTHER

Principal Investigators

  • Jesse Roman, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04193592 on ClinicalTrials.gov