Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients - Full Text View

Sponsor:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00871845

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:

MedlinePlus related topics: Diabetes Medicines Hepatitis Hepatitis A Hepatitis C Liver Diseases Metabolic Syndrome Obesity

Drug Information available for: Orlistat Hepatitis A Vaccines

U.S. FDA Resources

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

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
Hepatitis A
Hepatitis C
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 May 24, 2012