Chronic Hepatitis CPhase 4NCT00351871
Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy
A Phase 4 study testing PEG-Intron Plus REBETOL in people with Chronic Hepatitis C, run by Louisiana State University Health Sciences Center in New Orleans.
Trial summary
The objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis C virus treated with PEG Intron and Rebetol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- PEG-Intron Plus REBETOL
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Nov 2007
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of chronic hepatitis C infection (viremia) by RT-PCR superquantitative
- HCV Genotype 1
- Liver biopsy within 36 months of enrollment consistent with chronic hepatitis
- Compensated liver disease with laboratory parameters at entry visit as follows:
- Hemoglobin values of > 12 gm/dL
- WBC > 2,500/mm3
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- Neutrophil count > 1,000/mm3
- Platelets > 100,000/mm3
- Prothrombin time < 2 seconds prolonged compared to control, or equivalent INR ratio
- Bilirubin within 20% of the upper limit of normal unless non-hepatitis related factors exists such as Gilbert's syndrome.
- Albumin > 3.0 g/dL
- Serum creatinine < 1.4 mg/dL
- Normal thyroid stimulating hormone (TSH) or thyroid disease clinically controlled
- Antinuclear antibodies (ANA)< 1:160
- FBS < 126 mg/dl
- No significant co-existing psychiatric disease
- Free from substance abuse for past 2 years
Who cannot join
- Previous treatment for HCV.
- Evidence of being HIV positive.
- Hypersensitivity to alpha interferon, Peg Intron or Rebetol.
- Any other causes for chronic liver disease other than chronic hepatitis C besides obesity.
- Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
- Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or hepatic encephalopathy.
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- Preexisting medical condition that could interfere with the patient's participation in the protocol including: CNS trauma or active seizure disorders requiring medication; diabetes mellitus; serious pulmonary disease; immunologically mediated diseases; gout attack within 12 months; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- Patients with evidence of ischemia on stress testing, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months.
- Patients with a history of organ transplantation will be excluded.
- Patients taking insulin sensitizing drugs.
About this study
Official title: Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy
The objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis C virus treated with PEG Intron and Rebetol.
Read the detailed description
The relationship between HCV and IR is an evolving one. This study will allow a more formal evaluation of this relationship. Four hundred patients will be treated using weight based Peg Intron and Rebetol. Clinical and biochemical data related to IR will be collected to determine if any such factors can predict who will have a sustained virological response. To evaluate patients for insulin resistance, the HOMA score (the product of the fasting insulin level and blood glucose level), waist circumference, and body mass index will be measured.
- Conditions
- Chronic Hepatitis C
- Being tested
- PEG-Intron Plus REBETOL
- Keywords
- HCV
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-Intron Plus REBETOLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in treatment response rates between those with insulin resistance those without.
Secondary outcomes (1)
Which marker of Insulin Resistance (i.e. the HOMA score, Waste Circumference or BMI) is the best measure for risk of hypo responsiveness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startApr 2002
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- William M. Cassidy, M.D., Principal investigator, Louisiana State University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351871
- Sponsor's protocol ID
- P03851
- Status last verified
- Feb 2009
- First submitted
- 12 Jul 2006
- Last updated
- 4 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy
- ClinicalTrials.gov ID
- NCT00351871
- Acronym / sponsor ID
- P03851
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Apr 2002
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 13 Jul 2006 (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.
The objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis C virus treated with PEG Intron and Rebetol.
Detailed description
The relationship between HCV and IR is an evolving one. This study will allow a more formal evaluation of this relationship. Four hundred patients will be treated using weight based Peg Intron and Rebetol. Clinical and biochemical data related to IR will be collected to determine if any such factors can predict who will have a sustained virological response. To evaluate patients for insulin resistance, the HOMA score (the product of the fasting insulin level and blood glucose level), waist circumference, and body mass index will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Evidence of chronic hepatitis C infection (viremia) by RT-PCR superquantitative
- HCV Genotype 1
- Liver biopsy within 36 months of enrollment consistent with chronic hepatitis
- Compensated liver disease with laboratory parameters at entry visit as follows:
- Bilirubin within 20% of the upper limit of normal unless non-hepatitis related factors exists such as Gilbert's syndrome.
Key exclusion criteria (10 listed)
- Previous treatment for HCV.
- Evidence of being HIV positive.
- Hypersensitivity to alpha interferon, Peg Intron or Rebetol.
- Any other causes for chronic liver disease other than chronic hepatitis C besides obesity.
- Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
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 |
|---|---|---|
| PEG-Intron Plus REBETOL | Drug | – |
Primary outcome
Difference in treatment response rates between those with insulin resistance those without.
1 secondary outcome
Which marker of Insulin Resistance (i.e. the HOMA score, Waste Circumference or BMI) is the best measure for risk of hypo responsiveness.
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 4 Feb 2009.
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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.
William M. Cassidy, M.D. principal investigator
Louisiana State University Health Sciences Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-Intron Plus REBETOL in people with Chronic Hepatitis C, run by Louisiana State University Health Sciences Center in New Orleans.
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 17 inclusion and 10 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 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in treatment response rates between those with insulin resistance those without.. 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 4 Feb 2009.