Last reviewed · How we verify
NCT01652157
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)
trial testing ULTRESA in Fibrosing Colonopathy in 17 participants. Terminated before completion.
8 April 2020
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 17 |
| Start date | 31 July 2012 |
| Primary completion | 8 April 2020 |
| Estimated completion | 8 April 2020 |
| Sites | 123 locations across United States |
Drugs / interventions tested
- ULTRESA — full drug profile →
- PANCREAZE
- CREON (PROTEASE)) — full drug profile →
- ZENPEP
- other non-sponsor pancreatic enzyme replacement therapy
- PERTZYE — full drug profile →
- No pancreatic enzyme replacement therapy
Conditions studied
- Fibrosing Colonopathy — all drugs for Fibrosing Colonopathy →
Sponsor
AbbVie — full company profile →
Who can join
Adults 0 Months to 99, any sex, with Fibrosing Colonopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pancreatic enzyme replacement therapy for people with cystic fibrosis.
Somaraju URR, Solis-Moya A. · · 2020 · cited 26× · PMID 32761612 · DOI 10.1002/14651858.cd008227.pub4 -
Poster Session Abstracts.
· 2016 · cited 7× · PMID 27653516 · DOI 10.1002/ppul.23576
Verify or expand the search:
- PubMed search for NCT01652157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other AbbVie trials
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- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01652157 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 22 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01652157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing