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Fatty LiverPhase 4HCVNASHNCT00207311

Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus

A Phase 4 study testing Xenical, Pegasys, Copegus and Xenicare Program in people with Fatty Liver and Hepatitis C, run by Brooke Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of > 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naive) will be enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fatty Liver, Hepatitis C
What is being tested?
Xenical, Pegasys, Copegus and Xenicare Program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2005to May 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be willing to give written informed consent and be able to adhere to dose and visit schedules.
  • HCV-Ab or HCV-RNA by PCR Positive for at least 6 months
  • Serum positive for HCV-RNA by PCR assay
  • Treatment naïve participants who have hepatitis C with genotype 1, 2, 3, or 4
  • Body mass index >27
  • Liver biopsy within 12 months with a pathology report confirming the histological diagnosis consistent with CHCand NASH or hepatic steatosis of >33%
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  • Compensated liver disease with minimum hematological, biochemical, and serologic criteria at the Enrollment Visit (WNL = within normal limits):
  • Hemoglobin values of <12 gm/dL for females and <13 gm/dL for males
  • WBC <3,000/ mm3
  • Neutrophil count < 1,500/mm3
  • Platelets <65,000/ mm3
  • Direct bilirubin within 20% of ULN
  • Indirect bilirubin WNL
  • Albumin > 3 gm/dL
  • creatinine < 20% of ULN
  • TSH WNL
  • Alpha fetoprotein value < 100 ng/mL
  • Reconfirmation and documentation that sexually active female subjects of childbearing potential are practicing adequate contraception method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for six months following the last dose of study medication
  • Reconfirmation that sexually active male subjects are practicing two acceptable methods of contraception

Who cannot join

  • Women who are pregnant or breast-feeding
  • Males whose female partner is pregnant
  • No other Thiazolidinedione after liver biopsy and/or during the entire study
  • Hepatitis C of non-genotype 1,2,3 or 4
  • Previous anti-viral therapy for treatment of Hepatitis C
  • Suspected hypersensitivity to interferon, PEG-interferon, ribavirin, Xenical
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  • Any other cause for liver disease other than chronic hepatitis C and NASH or steatosis, including but not limited to:
  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Co-infection with HBV
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Drug-related liver disease
  • Any condition that would prevent the subject from having a liver biopsy
  • Hemoglobinopathies (e.g., Beta Thalassemia)
  • Evidence of advanced liver disease
  • Patients with organ transplants other than cornea and hair transplant
  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
  • Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
  • CNS trauma or preexisting/active seizure disorders uncontrolled with medication
  • Significant cardiovascular dysfunction within the past 12 months
  • Poorly controlled diabetes mellitus
  • Chronic pulmonary disease with documented pulmonary hypertension
  • Immunologically mediated disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis
  • Any medical condition requiring, or likely to require chronic systemic administration of steroids
  • Evidence of an active or suspected cancer or a history of malignancy where the risk of reoccurrence is ≥ 20% within 2 years
  • Active clinical gout
  • Substance abuse
  • Participants not willing to be counseled/abstain from alcohol
  • Participants with clinically severe retinal abnormalities
  • Any other condition that in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol
  • Known positive HIV
  • Inability/unwillingness to provide informed consent or abide by the requirements of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

Other trials in United States

About this study

Official title: A Multi-Centered, Prospective, Randomized, Placebo-Controlled Clinical Trial for the Treatment of Significant Steatosis or NASH With Xenical Followed by Treatment of Hepatitis C (HCV) With PEG-Interferon Alpha-2a/Copegus

This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of > 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naive) will be enrolled.

Read the detailed description

Recent evidence suggests that patients with concomitant chronic HCV infection and NASH or significant hepatic steatosis (>33%) respond less well to standard antiviral therapy. As previously noted, up to 10% of patients with chronic HCV infection will have concomitant NASH and an even greater percentage will have associated hepatic steatosis. No prospective studies to date have evaluated the sustained viral response rates to standard antiviral therapy in this group of patients who were previously treated with a medication to eliminate or improve the underlying NASH and/or hepatic steatosis.

Primary Outcome: To determine if decreasing the amount of NASH or hepatic steatosis in overweight (BMI >27 kg/m2) HCV patients results in improved overall SVR to PEGASYS and Copegus.

Secondary Outcome: 1.To determine the amount of steatosis, necroinflammatory activity, and fibrosis change in a group of participants with chronic hepatitis C and NASH or significant steatosis treated with Xenical vs. placebo for 36 weeks. 2. To assess for a difference in insulin resistance, as measured by the QUICKI score, before and after treatment with Xenical or Xenical placebo and diet and exercise.

Being tested
Xenical, Pegasys, Copegus, Xenicare Program
Keywords
Hepatitis C, Fatty Liver, NASH, Steatohepatitis
Medical subject headings
Fatty Liver, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xenical, Pegasys, CopegusDrug

    Also called Xenical (orlistat), Pegasys (PEG-Interferon alpha-2a)

    Xenical 120mg three times daily for 36 weeks or xenical placebo (Arm 1). Pegasys 180 mcg weekly for 48 weeks. Ribavirin daily for 48 weeks.

  • Xenicare ProgramBehavioural

    Also called Xenical placebo, Pegasys (Peg interferon alpha-2a)

    Xenicare program for 36 weeks.

Study groups in NCT00207311
Study groupRoleWhat they receive
Xenical placeboPlacebo comparatorXenical placebo PO three times daily with meals plus enrollment into the Xenicare program for 36 weeks followed by 48 weeks of therapy with Pegasys (180mcg/ml) plus weight based ribavirin for HCV genotype 1 or 4 and 24 weeks of therapy with Pegasys (180mcg/ml) plus 800mg ribavirin for HCV genotypes 2 and 3.
Receives: Behavioral: Xenicare Program
Xenical (orlistat)Active comparatorXenical (orlistat) 120mg PO three times daily with meals plus enrollment into the Xenicare program for 36 weeks followed by 48 weeks of therapy with Pegasys (180mcg/ml) plus weight based ribavirin for HCV genotype 1 or 4 and 24 weeks of therapy with Pegasys (180mcg/ml) plus 800mg ribavirin for HCV genotypes 2 and 3.
Receives: Drug: Xenical, Pegasys, Copegus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained virological response (SVR) defined as the percentage of participants with undetectable HCV-RNA as measured by the Roche AMPLICORTM HCV Test, v 2.0 (detection limit 50 IU/mL) at 24 weeks post completion of the treatment period

    Measured: 110 weeks

Secondary outcomes (1)

  1. Hepatic steatosis, necroinflammatory activity and fibrosis improvement at week 36 as determined by Dr. Elizabeth Brunt at Saint Louis University

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00207311
Sponsor's protocol ID
C.2004.140
Acronym
HCVNASH
Status last verified
Feb 2012
First submitted
13 Sep 2005
Last updated
14 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Xenical, Pegasys, Copegus and Xenicare Program in people with Fatty Liver and Hepatitis C, run by Brooke Army 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 19 inclusion and 34 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 14 Feb 2012. 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. Some participants in this study may receive a placebo. 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?

Sustained virological response (SVR) defined as the percentage of participants with undetectable HCV-RNA as measured by the Roche AMPLICORTM HCV Test, v 2.0 (detection limit 50 IU/mL) at 24 weeks post completion of the treatment period (time frame: 110 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00207311.

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 14 Feb 2012.

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