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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00614757
Other study ID # PKP0003
Secondary ID 00173
Status Suspended
Phase N/A
First received January 31, 2008
Last updated October 25, 2012
Start date May 2005
Est. completion date December 2013

Study information

Verified date October 2012
Source Midwest Biomedical Research Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how often patients with hepatitis C infection have abnormalities of sugar and fat utilization. Additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight.


Recruitment information / eligibility

Status Suspended
Enrollment 121
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ability to give written consent

- HCV RNA PCR positive for 6 months

- Normal Hgb, WBC,Neutrophils

- Platelets of >/= 65,000

- Direct Bili, within 20% ULN

- Albumin >3

- Serum Creatinine <20% ULN

- TSH WNL

- AFP </= 100

Exclusion Criteria:

- Women who are pregnant or breast-feeding

- No Thiazolidinedione, Metformin,unless required for the treatment of type II DM

- Hepatitis C of non-genotype 1,2,3

- Any other cause for liver disease other than chronic hepatitis C

- Hemoglobinopathies

- Evidence of advanced liver disease

- Previous organ transplant

- Severe psychiatric disorder

- Significant cardiovascular dysfunction within the past 12 months

- Poorly controlled diabetes mellitus

- Immunologically mediated disease

- Any medical condition requiring chronic systemic administration of steroids

- Evidence of an active or suspected cancer

- Substance abuse at the time of the study

- Known HIV

- Irritability or unwillingness to provide informed consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
N-acetylcysteine 20% 4ml
N-acetylcysteine 20% 4ml
N-acetylcysteine 20% in 4 ml
N-acetylcysteine 20% in 4 ml

Locations

Country Name City State
United States Kansas City VA Medical Center Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Midwest Biomedical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study 2 years No
Secondary One half of patients with insulin resistance will undergo 30 day treatment with N-acetylcysteine to see if we can measure an improvement in fasting insulin and glucose levels 2 years No
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