CancerPhase 2NCT01325584
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
A Phase 2 study testing Omegaven in people with Cancer and Hepatic Injury, run by Midwestern Regional Medical Center at 1 site in United States.
Trial summary
The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Hepatic Injury
- What is being tested?
- Omegaven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female; ages 18 to 80 years old
- Receiving treatment at Cancer Treatment Centers of America
- Receiving PN (either in the infusion center or at home)
- Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction
- Able to provide informed written consent
Who cannot join
- Hypertriglyceridemia (triglycerides [TG] > 400)
- Allergy to fish or egg protein
- Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
- Hemodynamically unstable
- Bilirubin > 5 mg/dL
- Documented liver metastases
Show all 14Show fewer
- Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
- Recent cardiac infarction (within 6 months) and taking plavix
- Severe hemorrhagic disorders
- Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism
- Active sepsis
- Undefined coma status
- In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion, Illinois, 60099
About this study
The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.
Read the detailed description
This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients > 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids \& benadryl will be administered \& Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).
- Conditions
- Cancer, Hepatic Injury
- Being tested
- Omegaven
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Also called fish oil
initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.
| Study group | Role | What they receive |
|---|---|---|
| Omegaven (compassionate use) | Experimental | This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Conjugated Bilirubin
Highest detected lab values will be summarized between baseline and end of study participation.
Measured: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Average Change in Alkaline Phosphatase
lab values will be summarized at baseline and as change from baseline to worst follow-up value.
Measured: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Number of Patients Experiencing Adverse Events
The number of patients reporting or experiencing adverse effects will be reported.
Measured: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Average Improvement in AST
Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.
Measured: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Average Improvement in ALT
Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value
Measured: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startOct 2012
- Primary completionDec 2016
- Study completionApr 2017
Why it stopped: Alternative product is now approved and available for use.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pankaj Vashi, MD, Midwestern Regional Medical Center
- Investigators
- Pankaj Vashi, MD, Principal investigator, Midwestern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325584
- Sponsor's protocol ID
- MRMC 10-06
- Status last verified
- Jul 2018
- First submitted
- 25 Mar 2011
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: At present, no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
- ClinicalTrials.gov ID
- NCT01325584
- Acronym / sponsor ID
- MRMC 10-06
- Conditions
- Cancer, Hepatic Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Alternative product is now approved and available for use.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Midwestern Regional Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Posted 27 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.
Detailed description
This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients > 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids \& benadryl will be administered \& Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omegaven (compassionate use) | Experimental | Drug: OmegavenThis is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female; ages 18 to 80 years old
- Receiving treatment at Cancer Treatment Centers of America
- Receiving PN (either in the infusion center or at home)
- Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction
- Able to provide informed written consent
Key exclusion criteria (14 listed)
- Hypertriglyceridemia (triglycerides [TG] > 400)
- Allergy to fish or egg protein
- Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
- Hemodynamically unstable
- Bilirubin > 5 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmegavenAlso: fish oilinitial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month. | Drug | Omegaven (compassionate use) |
Primary outcome
Maximum Conjugated Bilirubin
Time frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Highest detected lab values will be summarized between baseline and end of study participation.
Average Change in Alkaline Phosphatase
Time frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
lab values will be summarized at baseline and as change from baseline to worst follow-up value.
Number of Patients Experiencing Adverse Events
Time frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
The number of patients reporting or experiencing adverse effects will be reported.
Average Improvement in AST
Time frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.
Average Improvement in ALT
Time frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. At present, no plan to share individual participant data.
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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.
Pankaj Vashi, MD principal investigator
Midwestern Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omegaven in people with Cancer and Hepatic Injury, run by Midwestern Regional Medical Center at 1 site 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Conjugated Bilirubin (time frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.). The study lists 5 primary outcomes in all. 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 7 Aug 2018.