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Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)

NCT02323100 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-17

Study results available
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Summary

We propose to test the effectiveness of the combination of CF pancreatic enzyme replacement therapy (PERT) on absorption of Ravicti® and subsequent restoration of nasal epithelial cystic fibrosis transmembrane conductance regulator (CFTR)-mediated chloride transport during the nasal potential difference (NPD) test. Funding source FDA Office of Orphan Products Development.

Conditions

Interventions

DRUG

Ravicti low dose

8 am, 4pm and midnight

DRUG

Placebo

8 am, 4pm and midnight

Sponsors & Collaborators

Principal Investigators

  • Pamela L Zeitlin, MD, PhD · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-02
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02323100 on ClinicalTrials.gov