Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00871845
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

The purpose of this study is to determine whether obese people do not respond to hepatitis C treatment as well as lean people. This research studies whether obese people will show higher sustained virologic response rate if they lose weight by Orlistat use and dietary and lifestyle modification.


Condition Intervention Phase
Obesity
Insulin Resistance
Metabolic Syndrome
Hepatitis C
Drug: Orlistat
Behavioral: Dietary and Lifestyle modification educational sessions
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Dietary and Behavioral Intervention and Orlistat for Management of Obesity and Metabolic Syndrome on Response to Hepatitis C Therapy

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • HCV RNA [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times, ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • waist circumference [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]
  • skin fold thickness [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]
  • HOMA, IR [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1) non obese, naive
Patients naive to hepatitis C therapy with body mass index (BMI) <25
No Intervention: 2) obese, naive, control
Patients naive to hepatitis C therapy with BMI ≥ 30
Active Comparator: 3) obese, naive, orlistat

Patients naive to hepatitis C therapy with BMI ≥ 30 as an interventional group, patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy) at the health education room of center for liver diseases, to check dietary diaries. The dietary and physical education (given through up to 6 weekly sessions and subsequently up to 12 monthly follow-up meetings) will be presented.

Orlistat (60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy.

Drug: Orlistat
Orlistat 60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-HCV therapy.
Other Names:
  • obesity reducing medications
  • anti-obesity drugs
  • Xenical
  • Alli
Placebo Comparator: 4) obese, naive, Placebo

Patients naive to hepatitis C therapy with BMI ≥ 30 as an interventional group, patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy) at the health education room of center for liver diseases, to check dietary diaries. The dietary and physical education (given through up to 6 weekly sessions and subsequently up to 12 monthly follow-up meetings) will be presented.

Placebo will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy.

Behavioral: Dietary and Lifestyle modification educational sessions
6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy.
Other Names:
  • weight management classes
  • weight reduction counseling
Active Comparator: 5) obese, non-naive, orlistat

Patients non responder or relapser after previous course of Hepatitis C therapy, with BMI ≥ 25. Patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy. The dietary and physical education.

Orlistat 60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy.

Drug: Orlistat
Orlistat 60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-HCV therapy.
Other Names:
  • obesity reducing medications
  • anti-obesity drugs
  • Xenical
  • Alli
Placebo Comparator: 6) obese, non-naive, Placebo

Patients naive to hepatitis C therapy with BMI ≥ 30 as an interventional group, patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy) at the health education room of center for liver diseases, to check dietary diaries. The dietary and physical education (given through up to 6 weekly sessions and subsequently up to 12 monthly follow-up meetings) will be presented.

Placebo will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy.

Behavioral: Dietary and Lifestyle modification educational sessions
6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy.
Other Names:
  • weight management classes
  • weight reduction counseling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • positive diagnosis of hepatitis C, by Polymerase Chain Reaction (PCR
  • scheduled to start treatment of hepatitis C by peg interferon and ribavirin
  • agreeing to give a written consent to participate in this study.

Exclusion Criteria:

  • patients under 18 years of age
  • refusal to give a consent to participate in the study
  • history of recreational drug or alcohol use in the preceding 6 months
  • pregnancy by hCG pregnancy testing which will be done prior to and monthly during the 12 month hepatitis C therapy and for 6 months following the end of treatment
  • plan for pregnancy during the study period
  • failure to adhere to contraceptive methods
  • HIV disease
  • evidence of cirrhosis or confirmed hepatocellular carcinoma (HCC), evidence of decompensated liver disease or presence of other liver diseases such as hepatitis B, hemochromatosis, autoimmune hepatitis and Wilson disease
  • Patients will be removed from the study if they develop severe side effects to IFN (e.g marked depression, autoimmune reactions like thyroiditis, aplastic anemia..), severe side effects to ribavirin (e.g. marked hemolysis) or intolerance of Orlistat/placebo (e.g. allergic reaction, diarrhea, flatulence..) and withdrawal of the consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871845

Contacts
Contact: Hossam M Kandil, assist Prof 412-647-1170 hmk2@pitt.edu

Locations
United States, Pennsylvania
Center for Liver Diseases, UPMC. Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Hossam M Kandil, M.D, Ph.D    412-647-9268    hmk2@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Hossam M Kandil, MD, PhD assistant professor of medicine
  More Information

No publications provided

Responsible Party: Hossam Kandil, University of Pittsburgh Medical Center / Center for Liver Diseases
ClinicalTrials.gov Identifier: NCT00871845     History of Changes
Other Study ID Numbers: PRO07090035
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
obesity
hepatitis C
insulin resistance
metabolic syndrome

Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Hepatitis A
Insulin Resistance
Obesity
Metabolic Syndrome X
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat
Anti-Obesity Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014