Cystic FibrosisNCT01858519
Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy
An observational study of Cystic Fibrosis, run by AbbVie at 47 sites in United States.
Trial summary
This is a point prevalence study conducted entirely in the United States (US) to establish the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for pancreatic insufficiency compared with… Read more about this study
- Who is it for?
- Ages 2 to 99 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 1,310 participants
- Where
- 47 sitesUnited States
- Study dates
- Aug 2013to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) and patients with chronic disease not receiving any PERT.
Who may be able to join
- All Patients (PERT-exposed and unexposed controls) must meet the following criteria:
- Have a blood draw planned as part of their standard of care following enrollment into the study; and
- Provide informed consent/assent.
- Patients in the PERT-Exposed Group must meet the following criteria:
- Have been diagnosed with CF; and
- Have received PERT for a minimum of 6 months.
Show all 11Show fewer
- Patients in the Unexposed Control Group must meet the following criteria:
- Be under medical management for chronic disease;
- Never received any PERT product; and
- Match an enrolled PERT-exposed patient based on age and region-of-residence.
- Have a blood draw planned to be performed within 180 days of the matched PERT-exposed patient blood draw.
Who cannot join
- Has a porcine heart valve, a porcine-derived graft, or has had exposure to porcine derived insulin. This exclusion does not apply to previous porcine-derived heparin exposure. ;
- Refuses blood collection; or
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Site Reference ID/Investigator# 116382
Anchorage, Alaska, 99508
Site Reference ID/Investigator# 131935
Atlanta, Georgia, 30125
Site Reference ID/Investigator# 116452
Boise, Idaho, 83712
Site Reference ID/Investigator# 116461
Boston, Massachusetts, 02115
Site Reference ID/Investigator# 116876
Buffalo, New York, 14222
Site Reference ID/Investigator# 116462
Charleston, South Carolina, 29425
Site Reference ID/Investigator# 116442
Chicago, Illinois, 60611-2291
Site Reference ID/Investigator# 116458
Cincinnati, Ohio, 45267-0564
Site Reference ID/Investigator# 154681
Denver, Colorado, 80206-2761
Site Reference ID/Investigator# 116440
Gainesville, Florida, 32610
Site Reference ID/Investigator# 116463
Grand Rapids, Michigan, 49503
Site Reference ID/Investigator# 116441
Hartford, Connecticut, 06106
Site Reference ID/Investigator# 116457
Hershey, Pennsylvania, 17033
Site Reference ID/Investigator# 116856
Houston, Texas, 77030
Site Reference ID/Investigator# 116877
Indianapolis, Indiana, 46202
Site Reference ID/Investigator# 116445
Jackson, Mississippi, 39216
Site Reference ID/Investigator# 116875
Knoxville, Tennessee, 37916
Site Reference ID/Investigator# 116444
Little Rock, Arkansas, 72202
Site Reference ID/Investigator# 116595
Long Beach, California, 90806
Site Reference ID/Investigator# 116855
Los Angeles, California, 90027
Site Reference ID/Investigator# 116879
Los Angeles, California, 90027
Site Reference ID/Investigator# 116448
Los Angeles, California, 90033
Site Reference ID/Investigator# 136816
Louisville, Kentucky, 40202
Site Reference ID/Investigator# 116439
Madison, Wisconsin, 53792
Site Reference ID/Investigator# 116465
Maywood, Illinois, 60153
Site Reference ID/Investigator# 116882
Miami, Florida, 33136
Site Reference ID/Investigator# 116438
Morgantown, West Virginia, 26506
Site Reference ID/Investigator# 127584
New Haven, Connecticut, 06510
Site Reference ID/Investigator# 130461
New Hyde Park, New York, 11040
Site Reference ID/Investigator# 116450
New Orleans, Louisiana, 70112
Site Reference ID/Investigator# 141881
Niles, Illinois, 60714
Site Reference ID/Investigator# 116278
Norfolk, Virginia, 23507
Site Reference ID/Investigator# 116464
Oklahoma City, Oklahoma, 73104
Site Reference ID/Investigator# 116883
Omaha, Nebraska, 68198
Site Reference ID/Investigator# 116277
Orlando, Florida, 32803
Site Reference ID/Investigator# 127295
Peoria, Illinois, 61603
Site Reference ID/Investigator# 116880
Philadelphia, Pennsylvania, 19104
Site Reference ID/Investigator# 116467
Philadelphia, Pennsylvania, 19134
Site Reference ID/Investigator# 116466
Pittsburgh, Pennsylvania, 15224
Site Reference ID/Investigator# 116460
Richmond, Virginia, 23219
Site Reference ID/Investigator# 116455
Shreveport, Louisiana, 71103
Site Reference ID/Investigator# 116453
Sioux Falls, South Dakota, 57105
Site Reference ID/Investigator# 116449
Syracuse, New York, 13210
Site Reference ID/Investigator# 116435
Tampa, Florida, 33606
Site Reference ID/Investigator# 116276
Toledo, Ohio, 43606
Site Reference ID/Investigator# 116459
Tyler, Texas, 75708
Site Reference ID/Investigator# 116436
Wichita, Kansas, 67214
About this study
Official title: A Point Prevalence Study to Evaluate the Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Who Are Receiving Porcine-Derived Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors
This is a point prevalence study conducted entirely in the United States (US) to establish the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for pancreatic insufficiency compared with matched (age and region of residence) control patients with chronic medical conditions unexposed to PERT.
Read the detailed description
This is a multicenter, non-interventional point-prevalence study conducted in the US to determine the seroprevalence of antibodies to selected porcine viruses in pancreatic enzyme replacement therapy-exposed CF patients and in an unexposed control group with chronic medical conditions matched for age and geographic region of residence. Data collection includes demographic and medical history, pancreatic enzyme replacement therapy, transfusion history, and history of potential exposure to pig viruses. If a patient meets all the requirements of the study and provides a study specific informed consent/assent, a single blood sample is obtained as part of a planned standard-of-care blood collection.
This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Aptalis Pharma and Janssen Research \& Development, LLC.
- Conditions
- Cystic Fibrosis
- Keywords
- pancreatic enzyme replacement therapy, antibodies, porcine viruses, epidemiology, prospective
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CF patients receiving PERT | Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) | |
| Matched control patients unexposed to PERT | Patients unexposed to pancreatic enzyme replacement therapy (PERT); matched on age and location of residence to PERT-exposed CF patients with chronic disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses
Seroprevalence of antibodies to selected porcine viruses in cystic fibrosis (CF) patients exposed to porcine-derived pancreatic enzyme replacement therapy (PERT) compared with a 1:1 matched control group of patients with chronic disease unexposed to PERT
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories, Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Gerhard J Leitz, MD, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858519
- Sponsor's protocol ID
- JSPP-12-01
- Status last verified
- Dec 2020
- First submitted
- 17 May 2013
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Point Prevalence Study to Evaluate the Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Who Are Receiving Porcine-Derived Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors
- ClinicalTrials.gov ID
- NCT01858519
- Acronym / sponsor ID
- JSPP-12-01
- Conditions
- Cystic Fibrosis
- Keywords
- pancreatic enzyme replacement therapy, antibodies, porcine viruses, epidemiology, prospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,310 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories, Janssen Research & Development, LLC
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a point prevalence study conducted entirely in the United States (US) to establish the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for pancreatic insufficiency compared with matched (age and region of residence) control patients with chronic medical conditions unexposed to PERT.
Detailed description
This is a multicenter, non-interventional point-prevalence study conducted in the US to determine the seroprevalence of antibodies to selected porcine viruses in pancreatic enzyme replacement therapy-exposed CF patients and in an unexposed control group with chronic medical conditions matched for age and geographic region of residence. Data collection includes demographic and medical history, pancreatic enzyme replacement therapy, transfusion history, and history of potential exposure to pig viruses. If a patient meets all the requirements of the study and provides a study specific informed consent/assent, a single blood sample is obtained as part of a planned standard-of-care blood collection.
This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Aptalis Pharma and Janssen Research \& Development, LLC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF patients receiving PERT | – | –Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) |
| Matched control patients unexposed to PERT | – | –Patients unexposed to pancreatic enzyme replacement therapy (PERT); matched on age and location of residence to PERT-exposed CF patients with chronic disease. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) and patients with chronic disease not receiving any PERT.
Key inclusion criteria (11 listed)
- Have a blood draw planned as part of their standard of care following enrollment into the study; and
- Provide informed consent/assent.
- Have been diagnosed with CF; and
- Have received PERT for a minimum of 6 months.
- Be under medical management for chronic disease;
Key exclusion criteria (3 listed)
- Has a porcine heart valve, a porcine-derived graft, or has had exposure to porcine derived insulin. This exclusion does not apply to previous porcine-derived heparin exposure. ;
- Refuses blood collection; or
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses
Time frame: 18 Months
Seroprevalence of antibodies to selected porcine viruses in cystic fibrosis (CF) patients exposed to porcine-derived pancreatic enzyme replacement therapy (PERT) compared with a 1:1 matched control group of patients with chronic disease unexposed to PERT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- clinical study report synopsisLink provided by the sponsor.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard J Leitz, MD study director
Janssen Research & Development, LLC
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by AbbVie at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.