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NCT01652157 · ClinicalTrials.gov registry record
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
A clinical trial, sponsored by AbbVie.
- Terminated
- Registry status
- 17
- Enrollment target
NCT01652157: Clinical Trial study, sponsored by AbbVie.
NCT01652157 is a clinical trial that was terminated before completion, run by AbbVie. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652157 was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- 17 participants
- Enrollment target
Study Summary
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.
Primary Outcome
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
Interventions
- BIOLOGICAL ULTRESA
- BIOLOGICAL PANCREAZE
- BIOLOGICAL CREON
- BIOLOGICAL ZENPEP
- BIOLOGICAL other non-sponsor pancreatic enzyme replacement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-07-31 |
| Est. Completion | 2020-04-08 |
Why NCT01652157 stopped before completion
NCT01652157 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which ULTRESA is the first listed.
NCT01652157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01652157 about?
NCT01652157 is a clinical study titled "Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)". This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical...
What is the current status of trial NCT01652157?
This trial is currently terminated. The enrollment target is 17 participants. The study started on 2012-07-31. Estimated completion is 2020-04-08.
What interventions are being tested in trial NCT01652157?
The interventions under investigation include: ULTRESA (BIOLOGICAL), PANCREAZE (BIOLOGICAL), CREON (BIOLOGICAL), ZENPEP (BIOLOGICAL), other non-sponsor pancreatic enzyme replacement therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT01652157?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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