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New study tracks pancreas health in babies with cystic fibrosis

NCT ID NCT06506773

Knowledge-focused Sponsor: Vertex Pharmaceuticals Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study followed 79 infants with cystic fibrosis during their first year of life to see how well their pancreas works over time. Researchers measured a substance called fecal elastase-1 in stool samples to track pancreatic function. The goal was to learn more about the natural course of the disease in very young children, which may help improve future care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand how cystic fibrosis affects the pancreas in early infancy, potentially guiding earlier treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. It does not test any new drug or therapy, so it cannot directly lead to a cure or symptom relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

79 people

The number who actually took part.

Started

Jul 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Infants with CF less than (\<) 6 months of age at the index date who are not eligible for commercial Kalydeco™ (according to local product labels). The day of enrollment into this study will be referred to as the "index date".

Ages

Up to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participants with CF less than (\<) 6 months of age at the index date * Participants not eligible to receive commercial Kalydeco™ (based on local product labels) and are not receiving Kalydeco or any other cystic fibrosis transmembrane conductance regulator gene (CFTR) modulator Key Exclusion Criteria: * Participant whose mother took any CFTR modulator while pregnant with the participant, or who has any history of exposure to a CFTR modulator Other protocol defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Florence, Italy

  • Billings Clinic

    Billings, Montana, 59101, United States

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115, United States

  • British Columbia Children's Hospital

    Vancouver, Canada

  • Canterbury District Health Board

    Christchurch, New Zealand

  • Centre Hospitalier de Quebec - Universite Laval

    Québec, Canada

  • Charite Paediatric Pulmonology Department

    Berlin, Germany

  • Children's Nebraska

    Omaha, Nebraska, 68114, United States

  • Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fakultni nemocnice v Motole

    Prague, Czechia

  • Great Ormond Street Hospital for Children

    London, United Kingdom

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Johns Hopkins All Children's Hospital Outpatient Care Center

    St. Petersburg, Florida, 33701, United States

  • Kinderklinik III, Abt. fur Pneumologie

    Essen, Germany

  • Kinderspital Zurich

    Zurich, Switzerland

  • Klinikum Westbrandenburg (CF)

    Potsdam, Germany

  • Leeds Regional Children's Cystic Fibrosis Centre

    Leeds, United Kingdom

  • Leicester Royal Infirmary, University of Leicester

    Leicester, United Kingdom

  • McGill University Health Centre, Glen Site, Montreal Children's Hospital

    Montreal, Canada

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • Nottingham University Hospitals NHS Trust, Children's Clinical Research Facility

    Nottingham, United Kingdom

  • Pediatric Hospital Polanki named of Maciej Płażyński

    Gdansk, Poland

  • Prisma Health Clinical Research Unit - Midlands

    Columbia, South Carolina, 29203, United States

  • ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

    Toledo, Ohio, 43606, United States

  • Providence Pediatric Pulmonary & Cystic Fibrosis Clinic

    Spokane, Washington, 99204, United States

  • Queensland Children's Hospital

    South Brisbane, Australia

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Royal Hospital for Children

    Glasgow, United Kingdom

  • Royal Manchester Children's Hospital

    Manchester, United Kingdom

  • Royal Stoke University Hospital

    Stoke-on-Trent, United Kingdom

  • Sanford Children's Speciality Clinic

    Sioux Falls, South Dakota, 57105, United States

  • St. Luke's Cystic Fibrosis Center of Idaho

    Boise, Idaho, 83702, United States

  • Starship Children's Hospital

    Grafton, New Zealand

  • The Hospital for Sick Children

    Toronto, Canada

  • The Kids Research Institute Australia

    Nedlands, Australia

  • The Royal London Children's Hospital

    London, United Kingdom

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708, United States

  • University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital for Children

    Bristol, United Kingdom

  • Virginia Commonwealth University Hospital Systems, Children's Pavilion

    Richmond, Virginia, 23298, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Women's and Children's Hospital

    North Adelaide, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.