Last reviewed · How we verify
NCT03072667
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
trial testing Omegaven in Cholestasis. Approved for marketing.
Quick facts
| Lead sponsor | Catherine Cibulskis, MD |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
| Sites | 1 location across United States |
Drugs / interventions tested
- Omegaven — full drug profile →
Conditions studied
- Cholestasis — all drugs for Cholestasis →
- Liver Diseases — all drugs for Liver Diseases →
Sponsor
Catherine Cibulskis, MD
Who can join
Under 1, any sex, with Cholestasis or Liver Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and have not responded positively to currently available medical therapies. PNALD develops in newborns dependent on parenteral nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and nutritional fluids; although PN is necessary and life sustaining, it can result in severe liver disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03072667
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Omegaven
Trials testing the same drug.
- NCT04467138 — High Dose Intravenous Fish Oil Reduces Inflammation · completed
- NCT03662282 — Omegaven as Alternative Parenteral Fat Nutrition · Phase 3 · completed
- NCT03561194 — Omegaven Protocol:Intermediate Size Patient Population · approved for marketing
- NCT02148146 — Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis · no longer available
- NCT02328768 — Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children · approved for marketing
Other recruiting trials for Cholestasis
Currently open trials in the same condition.
- NCT04167358 — Linerixibat Long-term Safety, and Tolerability Study · Phase 3 · active not recruiting
- NCT05582447 — Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease · active not recruiting
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 NCT03072667 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Catherine Cibulskis, MD
- Last refreshed: 6 December 2018
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/NCT03072667.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing