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A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations

NCT03000348 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2021-04-14

Study results available
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Summary

This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.

Conditions

Interventions

DRUG

Cysteamine

Oral Cysteamine Capsule

DRUG

Placebo Oral Capsule

Placebo Oral Capsule

Sponsors & Collaborators

  • Agility Clinical, Inc.

    collaborator INDUSTRY

  • PSR Group B.V.

    collaborator INDUSTRY

  • NovaBiotics Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States
  • Italy
  • United Kingdom

Study Locations

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Entities

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 NCT03000348 on ClinicalTrials.gov