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Trial record 42 of 69 for:    ORLISTAT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00871845
Recruitment Status : Terminated (Protocol expired and not renewed)
First Posted : March 30, 2009
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hossam Kandil, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Obesity
Insulin Resistance
Metabolic Syndrome
Hepatitis C
Intervention Behavioral: Dietary and Lifestyle modification educational sessions
Enrollment 36
Recruitment Details  
Pre-assignment Details While the initial study design included a drug intervention, drug intervention was not done. The study team could not identify an adequate study population willing to undergo drug intervention and funding to cover the costs of the drug intervention. Therefore, the only intervention was weight loss instruction/management.
Arm/Group Title Lean Overweight
Hide Arm/Group Description Treatment naive HCV Genotype 1 infected patients with BMI<25 Treatment naive HCV Genotype 1 infected patients with BMI >=25
Period Title: Overall Study
Started 11 25
Completed 11 25
Not Completed 0 0
Arm/Group Title Lean Overweight Total
Hide Arm/Group Description Lean (BMI<25) Overweight (BMI>=25) Total of all reporting groups
Overall Number of Baseline Participants 11 25 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 25 participants 36 participants
Age > 50 years
4
  36.4%
20
  80.0%
24
  66.7%
Age ≤ 50 years
7
  63.6%
5
  20.0%
12
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 25 participants 36 participants
Female
7
  63.6%
14
  56.0%
21
  58.3%
Male
4
  36.4%
11
  44.0%
15
  41.7%
1.Primary Outcome
Title Percentage of Participants With HCV RNA (Early Virological Response)
Hide Description Early virological response (EVR) defined as a greater than 2-log10 decline in serum HCV RNA from the pretreatment baseline or an undetectable serum HCV RNA at treatment week 12
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lean Overweight
Hide Arm/Group Description:
Lean (BMI<25)
Overweight (BMI>=25)
Overall Number of Participants Analyzed 11 25
Measure Type: Number
Unit of Measure: percentage of participants
82 52
2.Primary Outcome
Title Body Weight Loss
Hide Description Mean weight change from week 0 to week 12
Time Frame Weight loss as of Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lean Overweight
Hide Arm/Group Description:
Lean (BMI < 25)
Overweight (BMI >=25)
Overall Number of Participants Analyzed 11 25
Mean (Standard Deviation)
Unit of Measure: kg
1.44  (3.82) 3.44  (4.12)
3.Primary Outcome
Title Percentage of Participants With Early Virological Response (EVR) and Significant Weight Loss
Hide Description EVR compared between overweight subjects who achieved significant weight loss (>=3%) and those who did not
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overweight Achieving >= 3% Weight Loss Overweight Not Achieving >=3% Weight Loss
Hide Arm/Group Description:
Overweight subjects who achieved significant weight loss (>=3%)
Overweight subjects who did NOT achieve significant weight loss (>=3%)
Overall Number of Participants Analyzed 15 10
Measure Type: Number
Unit of Measure: percentage of participants
69 33
Time Frame 12 weeks
Adverse Event Reporting Description Collected AEs related to nutrition and exercise interventions, not Hepatitis C therapy
 
Arm/Group Title Lean Overweight
Hide Arm/Group Description Lean (BMI < 25) Overweight (BMI>=25)
All-Cause Mortality
Lean Overweight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lean Overweight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lean Overweight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/25 (0.00%) 
Study design adjusted due to subject availability & financial constraints. The drug intervention was not done. Waist circum & skin fold thickness not done due to patient refusal. HOMA/IR not done as not available/performed by primary providers.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hossam Kandil
Organization: Allegheny Singer Research Institute
EMail: Hossam.KANDIL@ahn.org
Layout table for additonal information
Responsible Party: Hossam Kandil, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00871845     History of Changes
Other Study ID Numbers: PRO07090035
First Submitted: March 26, 2009
First Posted: March 30, 2009
Results First Submitted: October 16, 2017
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018